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|Source: The John MOYNAHAN Archives
It occurred to me though, that as many times as I had stared at this familiar photo of my great grandfather and all of the other men who served with him on the First Sandwich South Council, that I knew nothing about those other men at all. My curiosity got the best of me and I researched every one of them (and constructed their public family trees on ancestry.ca ) and I am delighted to share my findings with you here.
|First Sandwich South Council - January 1893
In 1861 (five years before my great grandfather was born) the Township of Sandwich was divided into SANDWICH EAST and SANDWICH WEST.
In 1893, SANDWICH EAST was further subdivided and SANDWICH SOUTH was created and a first council was elected. When my great grandfather MOYNAHAN became the first clerk, he was 27 years old and also teaching in one-room schoolhouses in Essex county as well as studying to qualify for his Civil Service Exam. My great grandfather MOYNAHAN taught school in MAIDSTONE at 18 years of age from 1884 until 1896 when he was 30 years old.
The very first meeting on January 16, 1893 went like this...
|Source: The Windsor Evening Record; January 18, 1893, Page 2 of 4
The Seven Men of the First Sandwich South Council
The seven men are written about individually in some detail below but I thought I would start by briefly providing some highlights of what I have learned of them here:
The first Reeve was Abraham COLE. He was of limited education, schooled on the old Cole homestead "and taught lessons of industry, economy and thrift". He took care of his parents in their declining years and retired to private life in 1907.
The first Reeve was Abraham COLE. He was of limited education, schooled on the old Cole homestead "and taught lessons of industry, economy and thrift". He took care of his parents in their declining years and retired to private life in 1907.
The first Clerk was John MOYNAHAN. He was my great grandfather and the first of his family to abandon farming and pursue a life of teaching and civil service. I marvel at how many jobs he held concurrently while also starting his family with his wife Mary BRODERICK.
The first Treasurer was James McAULIFFE. When he died at 62 years of age in 1929, he was the only Treasurer that Sandwich South ever had, filling that post for 35 years. Prior to establishing himself on Talbot road, in 1889 McAULIFFE was elected Councillor of Sandwich East but disclaimed the seat on account of his youth.
The first Councillors were:
- Edward MOONEY While on his way to the Maidstone fair, a train struck Councillor Mooney's two seated Democrat carriage killing his two young sons and hired hand Denis BURKE. Young Addie JONES of Comber, Ontario narrowly escaped death along with Councillor Mooney.
- Charles McGUIGAN His parents Peter and Margaret McGuigan came from County Down Ireland, his father Peter served as a sergeant in the British Army. The family originally settled in Niagara then shortly after moved to Sandwich, Ontario.
- John GREAVES He received his education in England and New York and went on to become one of the largest landowners in Essex County. His wife Ellen (COLLINS) Greaves was an invalid for many years and it was always believed that she would predecease her husband. In 1908, when he died suddenly on the 7th of March, her death followed on the 17th of April 1908.
- Edward J. O'NEIL He had a long and dedicated record of service to the county (Councillor, Reeve, county roads supervisor, Warden and member of county council) and died due to a nervous breakdown and kidney trouble.
The first council meetings for the township of Sandwich South were held in, of all places, the bar of a hotel that owned and resided in by Mr. Michael McCARTHY of Oldcastle, and was located directly across from the site of the old township hall on Talbot Road (Highway #3).
|Newspaper clipping; John Moynahan archives
In 1896 a new township hall was built on land donated by Mr and Mrs Robert SYLVESTER and Mr. John WROTLEY was awarded the contract to build it for $640.00
The 1896 township hall was used until 1927 when it was replaced by the brick structure pictured below which was built by MORAND and RUSSETTE for $3,038.28, in the spring of 1927 opening officially on August 5th, 1927.
Michael McCARTHY of Lot 302 agreed to construct a ditch in the 1896 document below. The document bears the signatures of the witnesses that includes my great grandfather John Moynahan and Reeve Abraham Cole.
Michael McCARTHY of Lot 302 agreed to construct a ditch in the 1896 document below. The document bears the signatures of the witnesses that includes my great grandfather John Moynahan and Reeve Abraham Cole.
|Source: County of Essex Laserfiche document
|Source: County of Essex; Laserfiche
1893-1993 Centennial
|Re-enactment of First Sandwich South Council Meeting Source:
Tecumseh Tribune; January 22, 1993
On the occasion of the Sandwich South centennial in 1993, David WEEDMARK wrote about a time capsule that was buried at the Sandwich South Public Works Department (Hwy 3; the site of the old town hall that was torn down in 1980) and a re-enactment of the first Sandwich South Council meeting of 1893 where descendants of these early men took part (such as Abraham COLE'S descendant Mike TURTON)
|Sandwich South Centennial Time Capsule (1893-1993)
Source: "Sandwich South 100 Years" by David Weedmark
There is great comfort in the knowledge that the original chairs that were used by my great grandfather and the other men of the First Sandwich South Council (and pictured in the photograph on the men on Michael McCarthy's porch in 1893) still exist and have been preserved thanks to Sandwich South past Mayor Allan PARR.
|The 1893 Chairs
Source: The Tecumseh Tribune; July 31, 1998; Page 6 of 12.
The Men of the
First Sandwich South Council
First Reeve
Abraham Cole 1845-1928
|Abraham Cole 1845-1928
The first reeve of Sandwich South was Abraham COLE:
- He was born the 11th of April 1845 in the Cole Homestead at Lot 12 Concession 7, Sandwich South. He was the 8th of 9 children.
- He lived on Lot 12 Concession 7, Sandwich South
- His parents are Charles and Ellen (DRISCOLL) Cole of Ireland
- His siblings are
- Thomas,
- Richard,
- Charles,
- Frank,
- Frances,
- John,
- James and
- William
- He married Maggie McGUIGAN (b 1849) on 11th of February 1879.
- His four children are
- Charles,
- Mary,
- Fannie and
- Gertrude
- He died at 83 years-of-age on the 21st of January 1928 at the home of his son-in-law Thomas HARRINGTON in Fordson, Michigan
- He is buried at St. Mary's cemetery, Maidstone, Ontario
|Source: Commemorative Biographical Record of The County of Essex, Ontario by J.H. Beers & Co
|Source: Detroit Free Press (Detroit, Michigan) 23 Jan 1928, Mon • Page 11
|Source: The Amherstburg Echo Newspaper; 28 Jan 1928
First Clerk
John Moynahan 1866-1933
|John Moynahan 1866-1933
After John's death in 1933, County Clerk Percy Coyle, a good friend of Johns for over 35 years said, "John was a stickler of the truth. He was strictly honest in his business dealings and I often thought, as I heard him debate, that it would be too bad if John caught anyone in a lie"
Another of John's fine characteristics Mr Coyle related was his stern application of live and let live. "He would never speak an unkind word about any person," Coyle said, "If he didn't fancy any particular person, you would never hear him say anything detrimental to that person. He was well liked by all his associates"
- He was born the 10th of May 1866 on the family farm at 298 South Talbot Road, Maidstone, Ontario
- He lived on 298 South Talbot Road in Maidstone, Ontario (Township of Sandwich East in 1867)
- His parents are Jeremiah Moynahan (born 6 South Middle Rd., Maidstone) and Mary Brennan from Kerry, Ireland
- His siblings are
- Nellie
- May,
- Mary,
- Kate,
- Ann,
- James,
- Clara and
- Maud
- He married Mary BRODERICK on the 10th of May 1898
- His children are
- Eileen, (1899-1994)
- Ernest, (1900-1974)
- Mabel, (1902-1945)
- Raymond, (1904-1980)
- Gerald (1908-1961)
- Bernard (1909-1974)
- He died at 67 years of age on the 26th of June 1933 at his home 251 Campbell Ave., Windsor
- He is buried at Heavenly Rest cemetery, Windsor, Ontario
|Source: The Border Cities Star; June 27, 1933
|Source: Essex Free Presss; 30 June 1933
|1974: Windsor Street named after John Moynahan
First Clerk of Sandwich South
Source: Essex Free Press; July 5, 1974
First Treasurer
James Walter McAuliffe 1863 - 1929
- He was born on the 2nd of January 1863 in Sandwich East, Ontario on Tecumseh Rd. near Little River
- He lived on Talbot Rd. moving there in 1889 (40 years before his death in 1929)
- His parents are Patrick McAULIFFE and Ellen HOUGH
- His siblings are
- Margaret,
- John,
- Leonard,
- Thomas and
- Frank
- He married Ada HALFORD on the 4th of July 1898
His five children are
- Patrick, (b 1903)
- Paul, (b 1905)
- James, (b1907)
- Gertrude (b 1912)
- Thelma (b 1913)
- He died on the 31st of July 1929 at 62 years of age at Hotel Dieu hospital after a brief illness
- He is buried at St. Mary's cemetery in Maidstone, Ontario
|Source: The Border Cities Star, August 1, 1929
Edward J. O'Neil 1855-1919
- He was born on the 11th of August 1855 in Sandwich South on a 200-acre farm on the fifth concession
- He lived on this 200-acre farm on the fifth concession from the day he was born until the day he died
- His parents are James O'NEIL and Elizabeth SHUELL
- His siblings are unknown
- He married Alice Ann Holden on the 26th of February 1884
- His seven children are
- Justice, (b 1886)
- Nettie, (b 1888)
- Roy Valentine, (b 1890)
- Valetta, (b 1892)
- Rhoda, (b 1893)
- Wilfred, (b 1895)
- Della
- He died on the 10th of October 1919, Sandwich South after being ill for some time and his death was due to a nervous breakdown and kidney troubles.
- He is buried at Saint Stephen's Anglican Church Cemetery, Windsor, Ontario
|Edward J O'Neil
Source: Township of Sandwich Past and Present (Page 95)
John Greaves 1843-1908
- He was born on the 29th of June 1843 in Lancashire, England
- He lived at 291 South Talbot Road, Essex, Ontario
- His parents are John and Jane Greaves
- His siblings re
- Jane E.
- Betsey E.
- Mary
- Jos
- Sarah
- James
- He married Ellen Louis Collins (1851-1908)
- His children are
- Charles W (b 1868)
- John T (b 1868)
- George S. (b 1872)
- Albert (1875-1899)
- Ada (b 1881)
- Lily. (b 1889)
- He died the 7th of March 1908 in Essex, Ontario
- He is buried at North Ridge Cemetery, Essex County, Ontario, Canada
|John Greaves & Louisa Collins; Photo belongs to Julia Chupik
|Obituary John Greaves; Amherstburg Echo with thanks to the Marsh Historical Collection for clear copies
|Obituary Louisa (Collins) Greaves; Amherstburg Echo with thanks to the Marsh Historical Collection for clear copies
Charles McGuigan 1843-1923
- He was born September 8, 1842 in Amherstburg, Ontario
- He lived in Sandwich South
- His parents are Peter McGuigan and Margaret RAVEY
- His siblings are
- Margaret
- Peter
- James
- Alexander
- He married Ellen SEXTON
- His children are
- Peter (b 1875)
- Catherine (b 1877)
- James (b 1879)
- William (b 1880)
- Charles (b 1882)
- Thomas (b 1884)
- Leo (b 1886)
- Theresa (b 1888)
- Ann (b 1890)
- Mabel (b 1892)
- Samuel (b 1894)
- He died on the 12 September 1923 in Detroit, Michigan
- He is buried in Windsor, Ontario
Edward Mooney 1846-1907
- He was born in 1845 in Sandwich, Essex, Ontario
- He lived in Maidstone, Ontario
- His parents are Michael Mooney and Catherine SWEENEY
- His siblings are
- John
- Richard
- Elizabeth
- Rose
- Catherine
- Mary
- Ellen
- Michael
- Phillip
- He married Margaret Dixon (1854-1933)
- His children are
- William (b 1877)
- Thomas (b 1880)
- Bernard (b 1885)
- Marguerite (b 1887)
- Loretta
- Frank
- He died February 19, 1907 in Windsor, Ontario
- He is buried in St. Mary's cemetery, Maidstone, Ontario
A Horrible Railway Accident
Essex, Ontario 1895
Essex, Ontario 1895
While on their way to the fair, a train struck the two seated Democrat carriage carrying Councillor Edward Mooney, his two young sons, hired hand Denis Burke and a young girl Addie Jones of Comber, Ontario.
|The Windsor Evening Record: 2 October 1895
October 4, 1895, page 5. Horrible Railway Accident – the most horrible in it results of the numerous railway accidents that have happened at the M.C.R. crossing in this town occurred on Wednesday afternoon last at about 2:30 o'clock.
Councillor Edward Mooney, of Sandwich South, accompanied by his sons, William and Thomas, aged 10 and 17 respectively, his hired man Denis Burke, aged 26; and Miss Addie Jones, aged 17; were on their way to the fair, driving in a two seated democrat drawn by one horse.
The rig was struck about the front wheels and the young men were hurled into the air in various directions. Mr. Mooney and Miss Jones threw themselves from the rig in time to escape death, but Miss Jones fell almost under the wheels.
The bodies of the unfortunate Mooney boys were found a few feet to the north of the railway, while that of Burke was carried on the cow catcher several hundred yards before the train stopped and brought it back.
When the young men saw the danger they tried to urge on the horse but the frightened animal almost stood still and the time was too short for escape. The scene of the accident presented a terrible spectacle to the horrified bystanders ....the rig was smashed to atoms and the horse badly cit but will recover.
The bereavement to the families of the victims is a terrible one. The two brothers were the eldest sons of Mr. Mooney. The family consisted of four sons and one daughter, all of whom have been at home.
Denis Burke was a son of Denis Burke, Sr. who lives a few miles from Mr. Mooney's. He had one sister and one brother. All were unmarried.
Miss Jones was a daughter of Dow Jones, near Cottam, and was conveyed to her home on Wednesday evening.
The funeral of the victims was held at Maidstone church on Friday morning at 10 o'clock, and was probably the largest ever held at that place. There were 140 rigs in the drive from Mr. Mooney's home to the church where 100 more were met from the home of Mr. Burke. The bodies of the brothers were interred side by side, with the impressive ceremony of the church, while that of Burke was interred in the family plot but a short distance away.


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Jan 25, 2019
Balanced Scoring Leads to Win: Game with Gogebic Saturday at 2pm
All players scored in a 110-70 win against Bethany JV. Dashawn Walker had 21 points. Jerimiah Coddon added 18 points. Termaine Daniels contributed 14 points. Cody Sticha 12 points in the win.
DCTC plays region rival Gogebic Saturday at 2pm.

subset: commoncrawl


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Storm ~ Lilac that is.
Our double-layer Belgian linen slings are just dreamy. The linen is super-soft from the minute you take it out of the box. Some customers (you know who you are!) have reported wearing the slings without their babies just because the linen feels so nice.
Its also super comfortable and super versatile. As ready for a spin around the park or office, as it is a quick cooking session in the kitchen.
Here we're wearing our Storm~Lilac linen essential sling. Storm is the perfect grey; Lilac a classic pale purple. Together, they're just irresistible!


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Rama Spa at Rama Candidasa Dive & Spa Resort
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In a tranquil setting surrounded by water features and lush tropical gardens, Rama Spa at Rama Candidasa Dive & Spa Resort is designed to soothe the senses and indulge you in a range of holistic treatments. A full menu of treatments for singles and couples are available, includes traditional Balinese treatments, beauty treatments or massage therapy.
- 2 couple treatment rooms
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Between a big career change and getting ready to move, I haven't been cooking as adventurously as I have in the past. I've relied mostly on recipes I've cooked before, easy meat and vegetable dinners, and the occasional frozen curry or pot pie.
I think all of the new recipes I've tried recently have come from one source, The Food Lab by J. Kenji Lopez-Alt. I've had great success with his recipes, but I am most inspired by the accompanying articles where he walks through his thought process, and all of the experiments he did while developing the final recipe.
As an example, check out his new post, Rethinking Beef Stroganoff. Every ingredient and technique used is scrutinized, which I totally geek out on. It helps provide context that's useful while cooking the recipe yourself, and it's often knowledge that can be re-applied to improving other recipes.
Here's a quick list of Food Lab recipes that I've cooked and enjoyed in the last year:
- White Chili With Chicken (and see my post)
- American Chop Suey
- Roasted Chickpea and Kale Salad With Sun-Dried Tomato Vinaigrette
- Black Bean Soup With Chorizo and Braised Chicken
- Sage and Sausage Stuffing
Once the move is done, I'm really looking forward to cooking more adventurously again. And to trying out some more Food Lab recipes — that stroganoff looks great!


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Huntington Beach Senior Center
Architectural Photography for Icon West
The Senior Center in Huntington Beach was completed in July 2016 for $13 million. This huge complex covers an entire block, and includes a gym, banquet hall, music room, game room, and much more.
Dennis Davis Photography has shot many of Icon West's construction projects, and the "Twilight Shot" is always required. The image of the building lit up with the amazing purple sky took over an hour to set up, but the purple sky only lasted 15 minutes.


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4/9ths of a Pizza
Sometimes I get sent mathematical papers that are both interesting enough in their result and quirky enough for me to want to present them here even if the maths involved is a bit harder than the stuff I usually put it on here. I'll explain the problem and one of the basic cases, but I'll give you the link for you to read the full solution in their own words.
Alice and Bob are dividing up a pizza and each want to get as much of it as possible akin to the cake cutting problem. However the pizza is divided up into radial slices beforehand with all n pieces not necessarily of the same size. Alice starts by picking any piece and from then the two players take turns in taking pieces, but they can only pick pieces which are adjacent to the pieces which have already been picked. Here is the start of an example game from the paper:
If n is an even number then Alice can guarantee least 1/2 of the pizza. Imagine we colour in the slices red and green in an alternating fashion. There exists a colour with at least half of the pizza, say red. Alice can start with any red piece and then just take whichever red piece comes up for grabs each time. If n is odd then Alice will get to take one extra piece so it feels like Alice should do even better, but coming up with a strategy is harder than it looks.
The paper from 2008 spends 15 pages laying out the strategy which guarantees at least 4/9ths of the pizza for Alice which is the currently the best strategy we have yet found. It is unknown whether we can do any better.


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You've no doubt heard about the trouble with cake baker Jack Phillips in Colorado, florist Barronelle Stutzman in Washington, and other creative professionals who refused to lend their artistic talents to same-sex weddings in recent years. Now that trouble has come to Virginia.
Brett and Alex Sandridge, owners of the wedding photography and videography business Gardenia Weddings, have become the latest victims of intolerance. The young married couple faced immediate backlash after politely telling a same-sex couple that they "would not be the best match to film [the] wedding." Brett and Alex made this decision because of how important it is for them to remain true to their beliefs. You can read about it here:
WDBJ 7: Same-sex couple claims Charlottesville-based photographer discriminated against them
CBS 19 News: Charlottesville-based wedding photographers refuse to serve same-sex couple
Brett and Alex probably had no idea that their small act of declining their artistic services in accordance with their conscience would ignite such a firestorm. Within 24 hours they had experienced a huge amount of backlash and a smear campaign so big that Facebook deactivated their page. Outraged crusaders from everywhere flooded the page with so many negative reviews that it may even put them out of business for good.
Sadly, this is what has come to be expected for anyone who doesn't fully embrace – and even lend their artistic talents in celebration of – the judicially-created concept of same-sex marriage.
What's unique about this situation is that it appears to be the first major flashpoint of the "wedding wars" within Virginia. Our state has enjoyed relative immunity from the merciless targeting of conscientious business owners in the wedding industry in large measure because Virginia has wisely declined to add the classifications of "sexual orientation" and "gender identity" ("SOGI") to our nondiscrimination laws. We know that such a law would be used to punish religious business owners, and we continue to point out this connection every chance we get. (Read my recent Op-Ed in The Roanoke Times about it.)
It is worth noting that Brett and Alex Sandridge are experiencing the market equivalent of a tar-and-feathering for their decision without any non-discrimination law on the books to punish them for their convictions. The free market – all on its own – acted with incredible swiftness to address the "harm" that this same-sex couple felt in being turned down by Gardenia Weddings. (The highly connected and instantaneous world of social media brought about a kind of swift response that a court could never dream of offering.) Now the Sandridges are on the verge of losing everything within just days of their decision because it was not in lock-step with the demands of the uncompromising Sexual Revolution. Now just imagine how terrible it would be for them if the same-sex couple had access to a "nondiscrimination" law with which they could use as a weapon against these business owners and tie them up in expensive litigation for years.
This situation certainly puts to rest the oft-repeated argument that Virginia needs SOGI laws because LGBT people are unprotected in society. Far from being unprotected, those identifying as LGBT have an army of motivated supporters ready to spring into action at a moment's notice– and in this case, even a long list of other wedding photographers all too eager to bless the couple with a free wedding photo/video package. It is clear that the only people in this scenario who may need more protection are the faith-based owners of Gardenia Weddings.


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There is a cut up in the Genetic Sexual Attraction neighborhood, as I have noted before. I actually discover this submit useful and simply needed to share my story: I actually have been in a relationship for almost 5 years now. So if you've been asking somebody or yourself How Do I Save My Relationship with My Boyfriend currently, then this could be your reply. If you're an individual who can easily match into totally different teams, conditions, eventualities, then an interracial relationship might be straightforward-peasy for you. So both parties bring their emotional reactivity, sensitivity, impatience, and any one of the above potential traits into the relationship. There was a good motive why the two of you formed a relationship within the first place, and that basis for the relationship ought to stay even after a couple of months apart. I know a sure girl from his work who has given me vibes of insecurity over our relationship. If your relationship has gone to the purpose of being interested in different individuals, do the honorable factor: TELL THE TRUTH.
I particularly like that you simply level out sometimes you have to face the robust questions about whether or not it's cash issues hurting the relationship or just a doomed relationship hiding behind cash woes. One of essentially the most most depressing experiences for a spouse is that feeling of isolation when her husband emotionally leaves the relationship. Whether a specific man she's gone courting with sees her as marriage materials/lengthy-term relationship or not. If these assertions are even partially true, then the physician-affected person relationship has serious implications for a very powerful side of health care in this nation: money. As labor markets are usually seen as perfectly aggressive, they are embraced as the first driver of the employment relationship. Disagreements in a relationship aren't only regular however, if constructively resolved, truly strengthen the relationship. These individuals are not searching for a relationship from you, but see you as an object.
If the reply is not any after which it isn't your fault and possibly your girlfriend has modified and desires one thing else in a relationship which you'll be able to't supply her now at this moment (though you might be capable to provide it when you wished to vary maybe). If the opposite particular person is just not providing you with enough space and acts overly possessive for no motive and even gets suspicious too soon, speak to your companion and attempt to make them perceive that faith and belief are the bottom of any relationship. The scenario you describe is abusive, and if that is the case, then there are probably underlying issues as properly.
If one individual brings a considerable amount of unresolved debt into the relationship (scholar loans, baby help, alimony), the new relationship will suffer for it. It can turn into quite challenging and possibly unsolvable. The issues should be addressed and if there isn't a fixing the problems then ending the relationship makes much more sense to me than dishonest.
This could appear to be they're simply being good and attempting to maintain a friendship, however it might additionally imply he's keeping track of your life and what you're up to. This type of communication is the best means they can preserve you of their life without having to make any fast choices concerning the destiny of the relationship.


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We've covered quite a few luxury travel destinations here on Luxefeed, and while it's clear that they're all mesmerizing, the ones concerning the Maldives are certainly in a league of their own. Today we're going to tell you a bit about Milaidhoo Island Maldives, which is synonymous with luxury, relaxation, and natural beauty. It is located within the Baa Atoll UNESCO World Biosphere, and it stands ready to impress with exquisitely blue waters, lush vegetation, fine sandy beaches, and lavish accommodations.
During your stay, you'll be able to engage in activities such as snorkeling, swimming, sunbathing, as well as visiting the nearby coral reef and experiencing its unique wonders. The accommodations that we mentioned before include no less than 50 land and over-water villas that boast bespoke art pieces, sun decks with private freshwater pools, and breathtaking views of the ocean.
However, we should definitely mention the over-water spa at Milaidhoo Island Maldives, which tempts with refreshing treatments for the body and soul, as well as the complimentary yoga and meditation classes, which can be enjoyed at the resort's open-air over-water pavilion.
Dining can be savored at one of the establishment's three restaurants, with the Signature Restaurant being the most prominent. That's because it serves a mix of seafood, meat, and vegetarian specialties that can be shared with loved ones while taking in magnificent sunsets and ocean views. Fishing, diving, dolphin cruises, and spotting whale sharks or manta rays are just some of the resort's highlights.


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Sep 27, 2013 - A Rose Worth Remembering by Sarah Scout
Long before I wrote this article in the spring of 2002, I went to an AA round up in Standoff Alberta, on the Blood reserve during Mother's Day weekend. There was a small Alcoholics Anonymous group who, every year had their AA round up on and around Mother's Day. It was there in that small gymnasium, I saw Rose for the very first time, when she got up at the front podium to welcome everybody who had made it down; a welcome to everyone, and an extra special welcome to the native people.
In her greeting, she said something, that to this day I have not forgotten, nor do I intend to forget for the rest of my life:
"It's good to see so many brown faces."
It's not often that Native People in Southern Alberta, (or anywhere) get recognition or acknowledgement. And I think that is why this quote stuck with me.
She was giving recognition and respect to all those native people who had decided to come out that day, to listen to stories that could hopefully help them with whatever they were struggling with in their lives.
That's why I was there, that's why we were all there.
And it wasn't until she said it, that I too realized, it was good to see so many brown faces!
I wasn't there when she died. And I wasn't there at her funeral. But for many, in all the incredible masses of people who did attend, I was told it was like losing your mother.
For those who still had mothers, it felt like that, and for those who had already lost their own mothers, it felt like they were losing them again.
She was my friend. The one who always smiled and gave me a hug when I got close. Who would hold your hand and just sit with you, a smile on her face, glad for the company.
I didn't know her for that long, but with Rose, you didn't have to.
She loved everybody.
And she lived.
So with that, I dedicate this to my friend Rose, her family, and to all those she made feel like family.
To Rose, whose one beautiful brown face I will miss seeing the most.
Rose Yellow Feet
March 12, 1927 — February 28, 2006
She sits there, quite as a mouse. A tiny smirk creeps up on her lips, and a glimmer of satisfaction can be read in her almond colored eyes. A satisfying advantage of knowing something not too many others do.
"This, never use to be here," she says, lifting her hand as she makes a gesture to the mini mall in front of us. We are sitting side by side in her white F-150 Ford Pick up truck. The Lethbridge parking lot is dry and dusty, even though it is early February. The screams of wind, and the unmistakable sound of traffic zooming up and down Mayor Magraph Drive is almost too much to take.
There are few people alive today who can still remember a time when the Blood Indian reserve was alcohol free. For most, conjuring up the thought of a reservation without alcohol is more then difficult to imagine. In fact, it almost sounds like a fantasy.
But for Rose Yellow Feet, remembering such a time is easy, because it is something she has lived through.
"At the time, you could count how many people drank on the reserve," she says, holding up her ten fingers.
"We weren't allowed to buy alcohol, if we did, we got charged for it."
A simple walk down memory lane with Rose Yellow Feet can cover almost three quarters of a century, simply because that's how old she is. At 74, she still laughs at things like ATM machines, because she finds it funny that machines give people money.
Being born only three years before the Great Depression, Rose remembers how the people in the community always helped each other, and how nobody ever fought.
"We were really good to one another," she says with a smile.
People always spared what little food they had so visiting guests could eat.
"Whenever people came around to a house they'd get served, even if it's just bannock."
If anyone wanted to travel somewhere, it had to be done with a horse and wagon.
"It took us a day and a half to get to Lethbridge from the reserve."
Today it takes less then an hour.
Though Rose was very young at the time, she realized how hard her family worked to get through.
"When I think about it, it wasn't the Great Depression, it was just survival."
Before the age of 10, Rose was made to attend the St. Mary's residential school.
"At the time, they said if the parents didn't take us to school, they would be put in jail…so everybody was sent to school."
The same message was going around the reserve for all the native children living there.
She attended the school with approximately 180 girls and boys, and kept going until she reached the age of 15.
"I hated the school…there was nothing for the poor people," said Rose, "I was one of the poor girls, my mother died when I was about eight, so I didn't have a mother."
"We always had to do what the rich girls wanted us to do, and if we didn't…we'd get pilled on."
Rose sees some of what she learned at the residential school, as some things she can laugh at today.
"We learned to read, write, go to church, and not to go to hell." said Yellow Feet.
Eventually, she broke away from school to visit a relative in the United States, a place where she had her first alcohol experience.
"I just stayed there, I didn't want to come back."
But Rose did come back. Too old to return to school, she had to see about settling into reserve life.
In the early 1940s of white society, a woman's main role for survival was to get married, raise children, and look after their husband. On the reservation, this way of thinking was exactly the same.
"That was the tradition at the time, it was no good to be single…the women had to get married," said Rose, recalling that single people were the most talked about people on the reserve.
"You had to have a husband. Either legally, or common law," said Yellow Feet.
"As long as you have a husband, you're OK."
This meant that invisible chains were being attached to girls like Rose, who weren't even interested in getting married.
During the '60s, alcohol was made legal for native people on the reserve.
"And that's when everything went bad."
Like the majority on the reserve, Rose too, turned to alcohol and lived with a man who was also into drinking.
"I got really abused…I always had black eyes whenever we'd drink."
Because there was no form of birth control made for women on the reserve, Rose had nine children. She described this time of her life as not knowing how to live on the outside, and having no clue of what to do.
"We all suffered."
"From the residential schools, we didn't learn how to be parents…there was no training of what was going to happen when we'd get out of there."
Against those odds, Rose and her family worked very hard to keep on surviving. They sold hay, and cut poles for fencing. With no electricity in the house, the family had to chop their own wood, carry their own water, and wash their clothes with a scrub board.
"We did everything ourselves," said Yellow Feet, "this is what I learned from my mother in law, and the people around me at the time. Not from the school."
"My husband did a lot of trapping…and I was always getting the fur ready for selling."
Rose was taught how to live off the land and trap her own animals when need be.
"We did a lot of fishing for food, and any meat we'd get, we dry it…I think we were healthier then we are now, with the food we ate."
But with the constant presence of alcohol, life for Rose quickly fell apart when she began drinking.
"I thought I was having fun, but when the alcohol got a hold of me, it just controlled me."
It wasn't long before she lost everything. With her children taken away and put into foster homes, Rose soon ended up on the streets all by herself.
"I was in Lethbridge…three years altogether," said Yellow Feet, "then I ended up in Edmonton on the streets, and in jail."
"There was no shelters, and none of these treatment centers…there was nothing."
"I wasn't even a bag woman, I had no bags to carry," says Rose with a chuckle.
Because most of her time was spent in jail, Rose saw jail as the only shelter the police had for people on the street.
"[Natives] were picked up for drinking off the reserve," said Rose, "drunk in a public place they call it now."
Yellow Feet says back then, there was no place for native people."I always think of the discrimination that we lived around, even when I was young, before I started drinking."
She recalls an experience that happened to her and a friend in the town of Cardston Alberta.
"We were walking, and there was a cafe there, it said: ALL WHITES ONLY!!"
Rose says the only place Indians could go to, was a restaurant which was run by a Chinese man.
"I always felt that discrimination, and I didn't like the white people…I always felt they looked down on us at the time."
In Lethbridge, Rose remembers sleeping in Galt Gardens in the summer time with other native people on the street.
"There was quite a few of us really, they'd do a clean up before Whoop-Up Days, and they send everybody to jail."
During other times, Rose said she always had somebody to take her off the street.
While Rose was in Edmonton, she drank everyday and got very sick, eventually putting herself in the hospital.
"I was taken to the hospital from the street, I thought that was the end of my life."
But she made it through, and from there, it was her doctor who referred her to the AA program, which means Alcoholics Anonymous.
"It was hard at first, but going to the meetings and being with the people that are sober really helped me to change my life."
Because of her complete lack of trust of white people, Rose went back and forth from the street in her first year of recovery.
"Finally, I learned that these people are not so bad, they welcomed me and invited me back."
After her first year of sobriety, she got all her children back from foster care. And after staying in Edmonton for five years, they moved back to Lethbridge, and eventually the Blood reserve.
This started a whole new positive change for Rose's life. She worked hard everyday to stay sober. Today, she has been sober for 37 years, and has had 38 years with the AA program.
The work she did from that point on would make her a phenomenon in the future, as being one of the most respected Elders on and off the reservation.
Starting with minor jobs like house keeping, Rose quickly resented the work she was asked to do.
"I didn't want to work there because they'd tell me to polish their doorknobs, and take a toothbrush and clean out their corners."
But with a little convincing from her AA sponsor, Rose knew she had to change her way of thinking. "I thought, oh OK, I'm getting paid for it, I'll do whatever they want."
Soon after, she received a job working as a bouncer in a halfway house for women.
"I walked out because they'd tell me to kick out some girls, and I didn't like that," said Rose, "they were the same girls [I knew] from jail, and on the streets."
After Rose left, a new harbor house was started called the McDougal House for Women. Rose was on the board to get the shelter going, and she was soon hired as one of the councilors.
From that point on, Rose said she never had to look for a job, because the jobs always came looking for her. She became the first director ofthe Sik-ooh-koto-ki Friendship Center, and helped start the Native Counseling Services.
"And when that started, they hired me as a court worker here in Lethbridge."
She was then asked to help develop the Nechi Treatment Institute in Edmonton, and later was elected to Chief and Council on the reserve.
In the 1980s, Rose saw that a lot of the youth were training themselves for alcoholism counseling. Realizing she wasn't as young as she use to be, she decided to go back to school and train to be a teachers aid.
Before receiving her diploma from the Lethbridge Community College, she was approached by a professor from the University of Lethbridge.
"Before I even put in my final presentation, the guy from the university said ' don't take any job, you're coming to the University."
There, she ran a program for Elders Health, and was asked to do a lot of public speaking to the students about her life experiences.
Retiring at the age of 65, for Rose, becoming an Elder almost sounds like a part time job.
Her two main interests she tries to keep up with today, are supporting the Friendship Center, and the new emergency shelter for people living on the streets of Lethbridge.
She is also honored as an elder at the Institute of the Aboriginal Women, a program made for all aboriginal women in Alberta.
In her spare time, (that is, when she has any) Rose enjoys making trips to the jails to talk to people who are in the same position she once was.
"That's how I contact the people from the street," said Yellow Feet.
"Nobody really noticed them as people, they're just drunks from the street. But I know how it feels…if only they knew what I know."
For Rose, staying sober has been the challenge of a lifetime, and more than anyone, she understands how hard it can be for those still addicted to drinking.
"You have to have the will if you want to sober up."
One thing she credits her sobriety to, is keeping herself busy by doing things she enjoys the most. Even when the times get hard, she always challenges herself to rise above. This was especially difficult, when she discovered she had serosis of the liver, and then a year ago, she lost her son. A time when she chose not to drink, because she knew her son wouldn't have wanted her to.
"If you don't know how to challenge, everything will get you down."
Right now, she says she's not really thinking about the future, she just wants to appreciate her life from day to day.
"I ask God to help me enjoy my last days of my life…I think it's better to be old now, and be treated good."
She can even look at her illnesses with less seriousness than most.
"My health is not too good now, I'm a diabetic with high blood pressure, and arthritis. I just about got everything," she says with a laugh, calling them her new diseases.
"It's a real challenge today to live with my sickness…to live with it, and try my best."
Without AA, and her faith, Rose believes she would have died years ago.
"Everywhere I go, I meet people that are very happy," said Yellow Feet, "I didn't do it just for being selfish, or to try and show off."
"I did it from my heart, because I suffered, and I know I want to help people."
Even her relationship with her children is better then ever, and now she has almost 20 grandchildren and great-grandchildren combined.
"They're always with me."
"Just keep trying your best, that's what the old people use to say, iyika'kimaap," says Rose.
"Do something that makes you happy."
Sarah Scout is an active urban Aboriginal writer and Indigenous Artivist in the Calgary, Alberta community where she has lived for the past ten years. From 2000 – 2002 she attended Lethbridge Community College where she studied print journalism and communication arts under D'Arcy Kavanaugh. Her work has been published in print mediums such as The Endeavour, The Lethbridge Herald, Say and Beatroute Magazine. From November 2006 – February 2009 she was the managing editor of New Tribe Magazine: Calgary 's non-profit Urban Aboriginal Youth Monthly. Founding the Aboriginal Writers Circle in 2007, Sarah created this group for Aboriginal writers, authors and storytellers to come together in celebration and exploration of the written word and oral storytelling tradition. In her spare time, she also creates and distributes her own independent zines which document personal anecdote, stories, life writing experience and poetry in a mixed collage of black and white photography and experimental graphic design. Her zine titles include: Out Cast By Choice, Out Cast By Choice: Issue Two – A Choice of Futures Waiting To Happen, Jack Rubber, Assimilated Ego, Assimilated Ego 2 and Indian Grave Yard. Winner of the Royal Bank of Canada Aboriginal Student [two year] Scholarship in 2009, Sarah studied at the University of Calgary in pursuit of her BA in English. She currently is writing her first 'life writing' novel "Incomplete Indian: The Indigenous Life Writings of Sarah Scout."


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By Sarah Taylor
Since 2012, the Burmese minority Muslim population has been the victim of increasingly violent attacks from the country's Buddhist majority. The rape of a Buddhist woman in 2012 in the state of Rakhine in northwest Burma led to the latest upswing of communal violence between the two communities. At least 300 people, mostly Rohingya Muslims, died.
The Burmese government and military have done little to prevent the spread of violence that has only gained momentum in the last two years. It has left at least 200 people dead and 150,000 homeless. However, calls from the UN and human rights organizations like Human Rights Watch to label the violence as an egregious human rights violation have fallen upon deaf ears in the Burmese capital.
The Rohingyas are an unrecognized, majority-Muslim ethnicity in Burma where they have lived for at least the past 200 years, but the Buddhist majority in the country does not recognize the Rohingyas as a legal ethnic group. The United Nations defines the Rohingyas as a "religious and linguistic minority from western Myanmar" and "one of the most persecuted minorities in the world."
Hostilities against the Muslim minority throughout Burma, not just the Rohingyas in Rakhine state, have been mounting for decades. The anti-Muslim, pro-Buddhist movement called the 969 Movement has been credited with carrying out many deadly attacks and spreading violence against Muslim communities throughout Burma.
Ashin Wirathu, one of the leaders of the 969 Movement, calls himself the "Buddhist bin Laden." Time Magazine named him in a 2013 article as "The Face of Buddhist Terror," highlighting Wirathu's own anti-Muslim campaigns that have called for Buddhists across Burma to shun Muslim businesses and communities, not unlike the call across Nazi Germany to shun Jewish businesses.
Following the violence, many Rohingyas in Rakhine fled to neighboring Bangladesh. More than 200,000 of them now live in refugee camps run by the United Nations High Commission for Refugees (UNHCR), but only 30,000 of those refugees are legally registered and benefit from aid from the Bangladeshi government. The remaining 200,000 unregistered refugees do not.
This is not the first time that communal violence and deadly riots have forced the Rohingyas from their homes in Myanmar. The Burmese government executed, imprisoned, and tortured Rohingyas both in 1977 and from 1991-1992, forcing hundreds of thousands of Rohingyas to flee into Bangladesh.
The current President of Burma, Thein Sein, responded to the 2012 return of ethnic violence by calling for the deportation of all Rohingyas, but backed off his original statement by organizing a committee to investigate the violence and on occasion suggested the government should offer the Rohingyas citizenship. In response to an angry backlash from the Buddhist Burmese, President Thein rescinded his offer. Even Burmese international icon, Aung San Suu Kyi, has remained silent on the issue in an appeal to her political base, which is majority Buddhist.
Where are foreign aid groups? Many aid groups like Doctors without Borders and the Organization of Islamic Cooperation have attempted to observe the crisis, but Rakhine Buddhists have succeeded in keeping them out of Burma for the most part. With the economic liberalization of Burma many nations have invested in Burma's economy. However, since most foreign investments are limited to the oil and gas sector, they have not benefitted rural states without infrastructure and oil reserves, like Rakhine state.
Is this an example of ethnic cleansing? Thant Myint-U, one of Myanmar's leading historians, stated, "There's a deep-seated prejudice against many minority communities." In 1982 the government's Citizenship Law declared the Rohingyas to be recent immigrants to Burma, even though many of them had lived in Burma for centuries. The declaration effectively rendered the Rohingyas stateless. The Buddhist Rakhines and the Muslim Rohingyas existed peaceably for years. In 2013 the government enacted a two-child policy for the Rohingyas. Government officials have long pointed to the high birthrate of Burma's Muslim communities as a cause of the rising tensions, a claim that a recent Harvard University study found to be untrue. Burmese citizens fear unemployment and persistent poverty, made worse by a growing population. By forcing out some of the country's one million Rohingyas, the Buddhist Burmese may hope to lower the country's rate of unemployment.
At this moment, the situation looks like apartheid. The Burmese state denies Rohingyas their basic rights, such as access to food, education, and healthcare, and keeps them in crowded and disease-infested camps for internally displaced peoples (IDPs). In 1993, shortly after the ethnic cleansing of the Bosnia-Serbia war, Foreign Affairs defined ethnic cleansing as the "expulsion of an "undesirable" population from a given territory due to religious or ethnic discrimination, political, strategic or ideological considerations, or a combination of these." The pattern of violence against and departure of Muslim Rohingyas seem to follow this definition.
By allowing the violence to continue, Burma puts two things at stake. First it gambles with the lives of up to 1 million Rohingyas. Even President Sein has, at times, suggested the best solution to the violence is to send the Rohingyas to refugee camps where international NGOs could take care of them. Second, Burma threatens its stability and the preservation of democracy.
The increase in violence may be due to the country's shift toward democracy, which has coincided with a general shift in the country's attitude away from tolerance and toward extremism. Two years ago the government loosened restrictions on street demonstrations, along with other revolutionary political and social reforms. Before the reforms, if a newspaper produced unverified and anti-Muslim propaganda in the time of the military junta, the censorship machine would shut the newspaper down. The introduction of the free press has proved to better spread inflammatory and "unsourced" information. According to the International Crisis Group, the senior military commander for the state admitted that some of those involved in the riots might be trying to stop the broader political reforms going on in the country by turning communities against each other. The military, in an attempt to maintain power and influence, may use the increase in violence as an excuse to seize power in a coup.
Buddhist extremists legitimize their campaign of violence through fear tactics, promoting Islamaphobia through claims of a "global Muslim power". Rather than face the reality of the growing public support for violence against Muslims, Burmese politicians purport to support peace and non-violence while condoning the attacks with their refusal to enact any real action. In this video, journalist Nicholas Kristof interviews not only Buddhists actively promoting hatred against Muslims but also those go so far as to actually deny the existence of the Rohingya as an ethnic group.
The violence in Myanmar against its Muslim minority parallels an increase in violent attacks against Muslim homes and businesses in Sri Lanka. About 10% of Sri Lanka's population is Muslim, which is considered both a religion and ethnicity in Sri Lanka. Buddhist nationalists have stirred up violence and conflict between the Buddhist and the Muslim communities that rarely existed until the last thirty years. This is especially troubling, given that the latest wave of violence occurred in late June 2014 and left many Muslims dead or homeless. The attacks came after an inflammatory rally organized by the Buddhist extremist group in Sri Lanka, Bodu Bala Sena.
By no means do all Buddhists support violence against Muslims. The Dalai Lama himself, the world-renowned Buddhist spiritual leader, has called on both Sri Lankan and Burmese Buddhist officials to halt the violence, but to no avail.
Image Source: UN Office for the Coordination of Humanitarian Affairs


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Research Article Volume 4 Issue 4
1Puma Biotechnology Inc., Los Angeles, CA, USA
2Puma Biotechnology Inc., South San Francisco, CA, USA
3BioMarin Pharmaceutical Inc., Brisbane, CA, USA
Correspondence: Bin Yao, Puma Biotechnology Inc., 10880 Wilshire Boulevard, Los Angeles, CA 90024, USA, Tel (424) 248-6500
Received: August 20, 2016 | Published: September 1, 2016
Citation: Yao B, Ye Y, Yu H (2016) Data and Analysis Considerations in Oncology Clinical Trials.Biom Biostat Int J 4(4): 00101. DOI: 10.15406/bbij.2016.04.00101
Background: Oncology clinical trials are distinct from trials in other disease areas in its unique patient population, treatment and toxicity monitoring, endpoint assessment and follow-up. Promising innovative therapies to treat and prevent cancer have made oncology a fertile ground to conduct clinical research.
Purpose: To raise awareness and discuss relevant data and analysis issues that are critical to the ultimate success of oncology clinical trials.
Methods: We review data collection, cleaning, and analysis considerations in oncology clinical trials in the area of dosing, adverse events, tumor assessments, and survival follow-up. Operational issues relating to statistical analysis milestones and validation are also discussed.
Results: Upfront planning and careful considerations in data collection, monitoring, cleaning, and analyses have major impacts on the quality and conduct of the trial. Clear and appropriate data presentations not only enhance the interpretability of the results but also boost the confidence in the analyses.
Conclusion: Collaboration and coordination among multiple stakeholders and different functions of the trial sponsor are essential at all stages of a clinical trial. Special emphasis should be given to systematic approaches to collect appropriate data and to monitor data issues as early as possible to ensure quality in execution and clarity in reporting of oncology clinical trials.
Keywords: Oncology; Clinical Trial; Treatment Emergent Adverse Event; Dose Intensity; RECIST criteria; Data cut-off Date; Event-driven Analysis; Analysis Validation
Clinical trials have become a more complex undertaking. Trials that enroll patients globally are commonplace. Biomarker trials involving companion diagnostics become more sophisticated and require coordination and seamless execution from multiple stakeholders. Innovative trial designs involve upfront planning and attention to details in execution. These factors along with regulatory requirements have placed a greater burden on the sponsors to ensure that the data collected from the trials have unimpeachable integrity, quality, and validity to draw conclusions with respect to the objectives of the trials.
Data are arguably the ultimate measure of clinical trial performance. Appropriate trial design, well-thought-out case report forms (CRF) and clear CRF completion instructions are among the first steps to ensure data are consistenly collected in order to achieve the trial objectives. These efforts are augmented by ongoing data cleaning and monitoring to ensure data accuracy. Monitoring visits are one of the most resource-intensive activities to ensure valid data are collected against source documents. The US Food and Drug Administration (FDA) has provided guidance [1] on an integrated approach to monitor clinical trial quality and subject safety through a risk-based centralized monitoring approach. The main idea is to implement a central, systematic, and ongoing review of data which allows the monitoring to be more focused and data-driven. Continued advances in technology, data sharing standards including Clinical Data Interchange Standards Consortium (CDISC) [2], and the increasing sophistication of data visualization tools promise to increase efficiency and reduce clinical trial cost.
In this article, we focus on data collection and analysis issues in oncology clinical trials. In particular, we will take a deeper dive on data related to dosing, adverse events (AEs), tumor assessments, and overall survival. Special emphases are given to considerations in collecting relevant data and in identifying data issues in oncology clinical trials. We strongly believe that the biggest bang for the buck in monitoring trial conduct and ensuring quality comes from early identification of issues and trends so preventative and remedial actions can be put in place to avoid costly damages to the trial. Analysis and reporting considerations are also discussed to highlight the need for effective and clear presentation of data.
Treatment exposure
In oncology trials, treatment exposure is not only informative in its own right but also acts as an indirect measure of tolerability and even efficacy.
Actual versus prescribed dose: Dosing information is commonly captured in a log format with key elements such as start date, stop date, actual dose, and dose change reasons. When a dose is withheld due to AE, a record with zero actual dose and dose change reason as "withheld due to AE" is expected. When dosing records do not cover a period of time continuously, it is common to assume that there are no doses given during the gap. However, one cannot be certain if this is due to data entry error (that there is actually no dosing gap). Even though it's cumbersome, dosing records should cover the treatment period continuously with zero dose records always entered and the appropriate dose change reason provided when does are not given (either intentionally withheld due to AE or missed by accident by patients).
Some sponsors collect prescribed dose in the dosing log along with the actual dose. We think it provides useful information and suggest that care be given to the CRF design. In a hypothetical example, a patient may be prescribed with a reduced dose due to AE but accidently doesn't take the dose. A CRF with both the prescribed and actual dose along with the respective reasons of dose change can accurately capture the scenario. Table 1 outlines a sample dosing CRF incorporating the actual dose and prescribed dose.
Start Date
Stop Date
Prescribed Daily Dose
Actual Daily Dose (mg)
Reason for Prescribed Dose Change
Reason for Administered Dose Change (if different from prescribed dose)
Prescribed Dose Change Codes:
01 Reduced due to adverse events
02 Withhold due to adverse events
03 Resumed to previous dose level
04 Other (specify)
Administered Dose Change Codes;
01: adverse event
02: Other
In the above example,
DI = (200mg/day × 2+ 200mg/day ×1 + 100mg/day × 5)/10=110 mg/day
P-DI = (200mg/day × 5 + 100mg/day ×5)/10 =150mg/day
RDI = DI/ (200mg/day) = 55%
P-RDI = P-DI/(200mg/day)=75%
If the protocol specified treatment duration is 20 days, then the patient stopped after only 10 days of treatment. An alternative (unconditional) dose intensity and relative dose intensity may be derived as the following:
DI = (200mg/day × 2+ 200mg/day × 1 + 100mg/day × 5)/20=55 mg/day
RDI = DI/ (200mg/day) = 27.5%
Table 1: A sample dosing CRF and dose intensity calculations.
Pill Counts: For orally administered treatment, bottles of pills are dispensed to patients to be taken home. Patients are usually asked to keep dosing records in a diary. Upon return to the clinic, they are to return the unused pills and are dispensed with a new supply. As a part of the protocol procedure, sites are required to review and discuss the dosing diary with patients and to account for the returned pills. In addition, some sponsors design specific CRFs to capture each transaction of dispense and return of the bottles and pills. In theory, one can take the difference between each dispense and return to obtain the exact number of pills consumed and therefore the total amount of dose. In reality, such efforts do not always yield reliable results. Patients may forget to bring back a dispensed bottle at a visit; a bottle may be lost; sites may only guesstimate the number of returned pills as the actual counting is time-consuming for busy clinics. Any one of these issues poses challenges to rely on pill counts to capture actual dose administered. We view data collected from pill counts as a nice-to-have and potentially redundant to the dosing information collected in the log format described above.
Dose intensity and compliance: Dose intensity (DI) is expressed as the amount of dose per unit of time. It is calculated by dividing the actual cumulative dose by treatment duration. It is common in trials where treatment is given until disease progression. Dose intensity calculation is straightforward based on the above definition. However, in settings where treatment is given for a fixed period of time, for example in the adjuvant breast cancer setting where the standard of care is one year of trastuzumab treatment after surgery, for patients with HER2-positive disease, alternative definition of dose intensity may be relevant. If the protocol specified treatment period is for one year and a subject has stopped treatment after 6 months on drug, dose intensity may be calculated for this patient as the cumulative dose over 6 months or over one year. The former definition may be viewed as dose intensity conditional on the patient being treated. The latter definition insists on the protocol specified treatment duration regardless of the actual treatment duration (unconditional). While we are not advocating one definition of dose intensity over the other as the emphasis may be different depending on the situation, we recommend greater clarity and transparency when reporting results. In calculating treatment duration, it is common practice to add the dosing interval after the last dose. If prescribed dose is collected, prescribed dose intensity (P-DI) can also be obtained similarly.
Relative dose intensity (RDI) is calculated as the (actual) dose intensity divided by the protocol specified dose intensity. It compares the actual dose and schedule captured in dose intensity with the protocol specified intensity (protocol specified dose and schedule). With the exception of over-dose (which should be monitored and flagged), a higher RDI represents closer adherence to the protocol specified dose and schedule. Prescribed relative dose intensity (P-RDI) can also be obtained analogously reflecting prescribed rather than the actual dose and schedule relative to the protocol dosing specification. One may also be interested in calculating adherence ratio (AR), defined as the ratio between the (actual) dose intensity divided by the prescribed dose intensity. AR compares the actual dose relative to the prescribed dose with the understanding that prescribed dose has taken into account dose changes, if any, prescribed by the treating physician. It can be shown that AR may also be expressed as RDI/P-RDI.
Table 1 also includes hypothetical data of a patient to illustrate dose intensity and adherence calculations. By providing the details, we wish to highlight the nuances in summarizing dose exposure and intensity.
Dose intensity is a single summary measure incorporating both dose and treatment duration.When a treatment is given in cycles, as is common in oncology, summary measuressuch as dose received per cycle and percent of planned dose received per cycle may be more appealing. However, dose intensity and relative dose intensity may still be relevant as they capture delays of cycle time due to the need to manage treatment toxicities.
Adverse events
The collection of adverse events include description of the event, start date, stop date, seriousness, severity, relationship to study drug, actions taken and outcome. Typically, AEs are collected during the screening phase after informed consent has been signed and continues until the end of the protocol specified safety follow-up time. Ensuring the quality of safety data capture is the foundation of all pharmacovigilence activities. Common checks of the AE data include review of overlapping dates when more than one episodes of the same event of different severity are reported. Actions taken due to an AE should also be cross-checked against dosing data if it leads to a dose reduction or against the end of treatment reason if it leads to the discontinuation of treatment. A more complete suite of cross checks with other data in the database such as labs, concomitant medication, death, or hospitalization should be a part of the standard built-in data cleaning process.
Treatment-emergent adverse events: Because AEs are collected after the date the informed consent is signed which may be prior to the initiation of treatment, treatment emergent adverse events (TEAEs) are often the primary focus of the safety analyses. The idea of TEAE is to include any AE that occurs or worsens after the initiation of treatment and before a pre-defined period of time (e.g. 30 days) after the last dose of treatment. ICH E9 [3] defines TEAE as an event that emerges during treatment but having been absent during pre-treatment, or worsens relative to the pre-treatment state. There are some controversies when implementing this. The following (Figure 1 & Table 2) present four cases that illustrate the key issues. It seems that cases 1 and 3 may not be considered as TEAEs since case 1 may be considered as a continuation of the same event and case 3 may be a continuation of the same event but with a lower grade. However, for cases 2 and 4, the AEs are recorded by investigators as separate episodes starting on Day 5. Because the severity grades are no worse than the pre-existing episode, one may argue the events are pre-existing and should not be counted as TEAEs. Following this logic, what about events of the same severity which start on Day 15 rather than on Day 5? One may be hard pressed to not include separate events long after a subject has received the first dose and has continued to receive doses. We advocate a simple and inclusive approach in that any AEs with a start date on or after the first dose date (and within the pre-defined period after the last dose) should be considered as TEAE regardless of pre-treatment conditions. The TEAE summary should be complemented by a separate summary of any AEs not considered as treatment emergent (AEs occurred pre-treatment or post the pre-defined period after the last dose). When applicable, and depending on the disease area, more in-depth summaries of TEAE taking into account of pre-treatment conditions may be explored. Finally, we want to emphasize the importance of providing clear and specific CRF completion instructions to the sites on adverse events that should be recorded as separate events and events that should be considered as continuing without an end date. In our experiences, this is an area that sponsors should proactively engage the sites during the study setup phase.
Pre-Treatment AE Records
Post treatment AE (recorded as a separate entry from the pre-treatment record)
Grade 2 headache started 5 days before the first dose, ended on Day 3 (Day 1 is the first dose)
Case 1
Grade 2 headache started on Day 4.
Data query, potentially the same event as the pre-treatment.
Case 2
Grade 2 headache started on Day 5
A new event of the same grade.
Case 3
Grade 1 headache started on Day 4.
A continuing event of a lower grade.
Case 4
Grade 1 headache started on Day 5.
A new event of a lower grade.
Table 2: Determining treatment emergent adverse events (TEAEs).
Incidence by severity grade: A popular way to present AE incidence table is to layer in the severity grade. For illustration purpose, we provide a simple example to highlight the issues when incorporating worst grade in the AE summary. In this example, ten subjects are given treatment A and have experienced AEs with system organ class of nervous system disorders (with preferred terms of headache and dizziness) and eye disorders (with preferred terms of dry eye and eye pain). Table 3 appears to yield some surprising results where, in the column of worst grade 1, 5 patients have reported grade 1 headache which is larger than the 2 patients reporting any grade 1 AE and the 4 patients reporting grade 1 nervous system disorders as the system organ class. This may be counter intuitive but is not an error. A patient experiencing a grade 1 headache is counted as grade 1 under headache (preferred term), but the same patient also has a grade 3 event (e.g., vision blurred) and is counted in the "Any AE" row under worst grade 3. The same applies when a patient has different severity of two preferred terms associated with the same system organ class . This can be, admittedly, quite confusing. We recommend that AE tables by severity grade using the layout as in Table 3 be shown with preferred terms (PTs) only, skipping the customary first row of "Any AEs" and the system organ class rows. A separate summary table on system organ class may be provided. An alternative layout (Table 4) avoids the issue by displaying the by-grade summary for PT only in rows rather than in columns. This is the recommended layout if one wants to include both the system organ class and preferred terms in the table.
Arm A (N=10)
All Grades
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Any AEs
Nervous System Disorder
Eye Disorder
Vision Blurred
Eye Pain
Table 3: AE by worst grade with system organ class and preferred term.
Arm A (N=10)
Any AEs
Nervous System Disorder
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Eye Disorder
Vision Blurred
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Eye Pain
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Table 4: AE by worst grade with system organ class and preferred term.
Tumor assessments
Tumor may be assessed over time by multiple modalities in oncology trials. These assessments contribute to the definition of key endpoints such as response rate and progression free survival (PFS). Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [4] is a set of standardized and widely accepted criteria used to assess tumor. Any modifications by the sponsor of the criteria should be documented in the protocol and in a radiology review charter.
Automated response assessment: There are three components in the overall tumor response assessment when RECIST criteria are used: target lesion response, non-target lesion response, and the appearance of a new lesion. Each individual lesion identified at the baseline (target or non-target lesion) are tracked and entered into the CRF. Investigator assessments of response of the target, non-target, and new lesions along with an overall response assessment are provided at each protocol specified tumor assessment time. Typically, investigators are expected to do their own derivations following the RECIST criteria and then provide the response assessment. Invariably, some errors occur along the way as some tumor burden calculations are in reference to baseline and some are in reference to the nadir (e.g., progressive disease), Sponsors may pick up these errors during the data cleaning process and issue queries. Since these queries may arrive long after the assessments have been done, investigators may or may not recall all the details why a particular response assessment is given. The time lag can be overcome by implementing a real time automated response derivation within the EDC so the investigators will get immediate feedback on any derivation errors or inconsistencies with the RECIST. Investigators should be allowed to overwrite the automated response assessment and ideally provide reasons for the discrepancy. We believe such an automated response system implemented in real time will help improve the efficiency of data cleaning and more importantly enhance the quality of the data. In addition, the investigators are given the flexibility to differ from the automated derivation to reflect the autonomy of investigator assessments.
Date of response and date of progression: In addition to the overall response assessment at each time point during the study, assessment date is also critical when it comes to defining a time-to-event endpoint such as PFS. Some sponsors require the date associated with the overall response assessment be provided in the CRF. Other sponsors require dates in the individual CRFs of target or non-target lesions but not dates of the overall response assessment. Regardless of the approach, clear instructions will need to be provided to the sites on how to fill in the dates when they are expected to provide an overall responseassessment date based on potentially different dates from each component of the assessment. The same instructions should be provided to data management and statistical programming staff tasked to derive the dates for analysis purposes. As a general principle, consistent with the FDA guidance [5], for progression based on unequivocal progression of non-target lesion or a new lesion, the disease progression (PD) date is the earlier date when PD is detected. If progression is based on target lesions where scans may be obtained at different times, the target lesion PD date is the date of the later scan when complete information is available to establish PD. For the overall response assessment when PD may be due to target lesions, non-target-lesion, or new lesions, the earliest date when PD is identified from any source is the date of PD. However, for time-to-response endpoint (partial response or complete response), the date of response is the last date when complete information is available to establish response.
Central Radiology Review: While RECIST is the standard for solid tumor assessments, its implementation in practice and consistency across global sites in a clinical trial setting can be challenging. As a result, independent radiology review is set up to assess response in a centralized and blinded fashion (although the trial may be open label) [6,7]. For the central review to be successful, a great deal of coordination and collaboration is essential among the study sites, sponsors, vendors, and central review providers. A charter is required to outline all the requisite steps and the handoffs. Data quality checks are important to be imbedded in the central review process.
Recognizing the independent nature of the central review, we recommend minimum sponsor involvement in influencing the data review. However, we encourage a thorough testing of the central review system at the beginning of the trial using a suite of pre-determined test cases to ensure that the data checks in place are compliant with the RECIST so the quality of the data can be relied upon by the sponsor at the time of the analysis.
Overall survival: Overall Survival (OS) is an objective endpoint and it's the gold standard to demonstrate clinical benefit in oncology trials. A key consideration in trial design and analysis when OS endpoint is involved is to minimize loss to follow-up. The trial protocol must draw clear distinctions between withdrawal from treatment and withdrawal from follow-up. Patients may withdraw treatment for any reason; however, every effort should be made to ensure that patients are followed up for OS and long term safety after terminating treatment. It's common to focus on deaths when the number of deaths may be used to trigger the analysis. Equal emphasis should be given to the adequacy of follow-up to patients who are censored. When there are substantial gaps in follow-up, censoring patients using the snapshot date is not advised. In addressing the loss to follow-up, some sponsors undertake public record search to identify death information. Such an approach is not without controversies as it may introduce bias because of different local regulatory and legal requirements. If data from public records are used in the analyses, we recommend the information obtained from this source be clearly flagged in the data to allow for additional sensitivity analyses.
Statistical Analysis
Design and analysis methods: For pivotal oncology trials, group sequential designs [8-10] allow for flexibility of one or more interim analyses and are the most commonly used designs. A complexity is introduced when more than one primary endpoint is involved in a group sequential design. The group sequential Holm procedure [11] has been proposed to handle both multiple primary endpoints (e.g. PFS and OS) and multiple analyses while controlling for the overall type I error rate.
Study adaptation [12-14] has been an area of fertile research although it has not gained wide-spread adoption in practice. Adaptations such as sample size re-estimation, switch of hypotheses (e.g. between non-inferiority and superiority), switch of analysis populations defined by a biomarker, dropping of an arm in a seamless phase 2/3 design are among the most researched. The growing interests in adaptive designs have prompted the U.S. FDA to issue a guidance document [15].
Bayesian designs and analyses have been adopted in phase 1 or phase 2 oncology trials with aims including dose finding or identification of winners among multiple treatments. For example, the I-SPY 2 [16] trial is a phase 2 randomized trial which used an adaptive design based on biomarker subtypes to evaluate novel agents in the neoadjuvant breast cancer setting. It employed response adaptive randomization based on Bayesian modelling of accumulating data. I-SPY 2 has the potential to speed the process of screening drugs with the goal of bringing safe and effective new drugs to market more efficiently.
Event trigger and data cut-off: In oncology trials, analyses are commonly event driven, i.e. the analyses will only occur when a pre-specified number of events (e.g. OS or PFS) are reached. Event goals are specified in the protocol and statistical analysis plan to ensure appropriate study power. In tracking the events, sponsors typically employ a statistical model [17-19] to project the time the event goal may be reached based on accumulating data. When the event goal is nearly reached, sponsors may project a data cut-off date in the future upon which all events up to the date will be included in the analysis whether the final number of events is more or less than the event goal. Alternatively, a sponsor may decide a data cut-off date upon actually observing the event goal. The data cut-off date needs to be communicated to all sites to ensure not only the event goals are reached as close as possible but also a clear understanding from sites that all data on or prior to the cut-off date must be entered and verified in a timely fashion. For interim analysis, if a different number of events from the protocol is obtained, some adjustment is necessary in the analysis, for example, the interim boundaries.
Data snapshot and filtering: For a live clinical database with EDC, data entry across global sites may occur at any moment in time either before or after the data cut-off date. Since the data cleaning and query resolution are unlikely to finish on the same day of data cut-off, a period of several weeks are commonly required to accomplish these activities. By the time a snapshot of the database is taken, a mixture of cleaned data (data prior to the cut-off date) and uncleaned data (data post the cut-off date and up to the snapshot date) is unavoidable.
This begs the question whether all data contained in the snapshot should be the basis for the analysis. Strictly speaking, the intended analysis is to include data up to the data cut-off date both from the perspective of event triggering and data cleaning. The fact that one ends up with additional data post the cut-off date has more to do with practicality than the intent. Sponsors opting to emphasize the original intent will necessarily want to filter out data contained in the snapshot that are beyond the data cut-off date. This is not a simple undertaking and requires careful planning. For example, an adverse event may have a start date before the data cut-off date but with a stop date post the data cut-off date. The stop date should not be used in calculating duration of the AE if one wants to strictly enforce the data cut-off in the analysis. It's also possible that an event (e.g. death) occurred post data cut-off. Assuming it's agreed that the death should not be counted as event in the main analysis, it's not always clear whether knowing the subject's death post data cut-off can be used to infer that the subject is alive on the data cut-off date (therefore the subject is censored on the date). We recommend using only data within the declared data cut-off date for all analysis purposes since there's no assurance that all sites enter data in a timely manner post the data cut-off date.
While "data filtering" described above is tempting with sound rationales, the benefits may not outweigh the time and efforts involved. This is especially true for interim analyses when data cleanliness is not of paramount concern compared to data timeliness. For final analyses, these extra efforts may be worthwhile.
Validation: Statistical analysis of the final or interim data is the climax of a clinical trial. The final analysis represents the fruit of labor from the patients, sites, sponsor and numerous collaborators around the world. The stakes are even higher when a phase 3 trial is reported. Since the results may be considered material for many publically traded pharmaceutical and biotech companies, time is a luxury that the sponsors do not have. To ensure accuracy of the results released to the sponsor management and then to the public, meticulous planning and seamless execution are essential. In our experiences, analysis outputs are typically generated by statistical programmers working in collaboration and under the guidance of statisticians. Programmers are expected to follow sponsor standard procedures in performing validation which forms the first line of defense. However, this alone may not be adequate as programmers tend to focus on data processing from raw data to analysis data (e.g. data conforming to CDISC standards) and from analysis data to analysis displays. We recommend a parallel, independent validation path from raw data directly to analysis results performed by statisticians or programmmers (more than one validators if necessary) for key endpoints so analyses are connected to the raw data. It reduces the risk of relying on the intermediate datasets and boosts the confidence on the final results.
Oncology clinical trials are among the most exciting and challenging. Enormous amount of interest, resources, time, and money are invested in oncology drug development. In the end, it all boils down to the data. Data quality and integrity are the cornerstones of all clinical trials. We have highlighted specific issues to consider in collecting, monitoring, and analyzing a wide range of data collected in oncology trials. These are by no means exhaustive nor should they be limiting. We have deliberately emphasized on issues that may be taken for granted in practice. We hope by sharing our experiences and recommendations, more awareness is raised toward designing and executing high quality oncology trials.
The Authors declare that there is no conflict of interest. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
©2016 Yao, et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and build upon your work non-commercially.


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23-24 June, 2016 | Renaissance Shanghai Putuo Hotel | 50 Tong, Chuan Road, Shanghai, CHINA
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Students at Walton High School are preparing to welcome Ace – the guitarist, writer and co-founder of iconic British rock band Skunk Anansie, who is swapping stage and studio for classroom to inspire the next generation of musicians.
A group of up to 50 young musicians will benefit from a unique lesson and insight into the music industry from Ace who, during a 20-year career, sold over five million records and toured the world seven times over, including headlining Glastonbury.
Currently Head of Creative Industry for The Academy of Contemporary Music in Guildford, Ace is a renowned music educator who co-wrote and taught the BA Hons Live Performance and A&R modules at the acclaimed Brighton Institute of Modern Music. He holds a Master of Arts qualification in Media and Project Management based in music education from London Middlesex University and operates his own London schools incorporating the 'Ace Method' of guitar tuition.
He will be visiting Milton Keynes on Tuesday, (November 10) as part of the Ace Tour, which is supported by the world's largest manufacturer of musical instruments, Yamaha,
Ace said:"I'm very much looking forward to visiting Milton Keynes. It's always amazing to be working with Yamaha sharing the passion for, and inspiring young musicians through their schools and programmes. Also working together with such prestigious events as Rock the House in Parliament and within Higher Education at the acclaimed Academy of Contemporary Music (ACM) is an honour and a pleasure!"
Yamaha have been working with Ace since organising the Under 19 section of Parliament's 'Rock the House' competition to showcase the UK's best new musical talent, of which Ace is a patron.
Yamaha Music Schools education manager, Nigel Burrows, said: "We are delighted to be working with Ace again this year and visiting a number of Yamaha Music Schools and Education partners. We share a common goal in trying to inspire young musicians and give them practical advice gained from our collective experience as well as providing them with a number of platforms to develop their talent. Ace's presentation is very inspiring and motivational tempered with a reality check that can only come from being a working rock musician."


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Surviving Mars Review
Our planet is far from perfect. It's polluted and overstressed, filled with war, and pushed to the brink of total ecological disaster. But worst of all, it isn't red. You see where I'm going with this? If you aren't sold on leaving Earth just yet, you still might want to sit down with Haemimont Games' newest building simulator, Surviving Mars. Why? Well, like an atmospheric moisture extractor, I'm going to condense everything you need to know.
Haemimont is known for their Tropico titles, and much like those, Surviving Mars has the player building a rags-to-riches settlement that thrives on exporting goodies. I recommend going with New Game as opposed to Easy Start, as this lets you set variables, such as starting funds, perks, and researched items. You even get to choose a landing site, which cleverly effects your playable map's terrain, available resources, and natural disaster frequency. Then you have scenario names to choose from, from easy to difficult, encouraging potential hundreds of hours' replay value. If you think this sounds surprisingly complex already, sit tight. In what constitutes the game's great drawback, Surviving Mars has a learning curve of planetary proportions.
At first, you'll get a fair amount of guidance. The game will guide you to the "build" menu, from which you'll want to build a solar panel, and then a charging station for your drones, the robotic worker bees that carry resources and construct buildings. After similar guidance to build concrete and water extractors, the training wheels start to slip off. This is where you'll have to be experimental, and my best advice is to just scan your eyeballs over available buildings and think to yourself, "what would I want next for a colony?" And then just build it... or inevitably try to and watch it not get done for days and then unintuitively find out you don't have enough resources. Moreso than in Tropico 5, there's definitely a chronic lack of active information conveyance from here on, with crucial gameplay intricacies buried in the pause menu's encyclopedia if not entirely unexplained. As you can imagine, this results in hours of intermittent trial and error as you move on to build your first settlement domes. But I urge you; stick to it, because along the way there's a special gaming experience.
Much of that comes down to the setting. I'm sure you've seen those eerie photos from our expensive little rovers out there, but there's something surreal, tangible, and authentic about this game's depiction of the Red Planet. It's this feeling of hope, loneliness, and humility that just pours from the screen, thanks in large part to the fact that all of this feels surprisingly grounded and plausible. Natural disasters occur, things break down and wear out, people have hopes, dreams and fears when they move in, and you have to maintain public support by keeping colonists alive, happy, and healthy. Suffice to say, Surviving Mars comes off as a reasonable approximation of the growing pains our species will face. This is complemented by an outstanding soundtrack that perfectly captures this bittersweet spirit. From soaring symphonies to forlorn piano interludes, I just couldn't get enough of it and don't think I ever will.
Beyond its emotional significance, Surviving Mars is generally fun and entertaining throughout. It's that "model train" type of satisfaction you'll get from any good management sim, but with an extra dose of cool factor, as if every object is a piece of a dusty space machine. Outside the domes, your base will have a network of windmills and solar panels, which connects to cables that run everything. Moxies and vaporizers supply oxygen and water respectively, which connect via a pipe system and are also used in fuel production, which occurs in factories, which have to be staffed, and now we move inside the domes. To keep people sane, you'll need to build gardens and recreational spots such as casinos. All of these will have to be placed carefully to maximize space, especially with your beginner domes. To keep out ne'er-do-wells and prioritize based on your desired industry, you'll have to exempt people with certain personalities from arriving. And it gets deeper, too. Yes, all of this is dumped on you at once without proper explanation, but when you figure it out, it's cathartic to watch it unfold. In other words, I was annoyed with the game's user-unfriendliness, but once I could grasp how things worked, I fell in love.
Finally, I should mention the port job. Being that this is a management simulator, console play was simply never going to be perfect. Text has a tendency to be smaller than needed, and inevitable as it may perhaps be, learning the controls will compound the daunting learning curve at hand. Once you get used to it, it's definitely functional, but I do have to call into question the bizarre omissions, like the inability to toggle from one object to another of the same type. Regardless, the transition was done well enough that I would recommend buying this based on where you feel most comfortable playing games.
I wish I could sit here and call Surviving Mars an excellent game, because once you get past the eight-ish hours of unnecessary enigmas, it approaches that. It's rich, intelligent, and deeply moving, succeeding as an entertaining simulation time sink and a profound, uplifting window into the future. And as headache-inducing as it could be, I was always having enough fun to figure it out, and I suppose that says it all. Surviving Mars is flawed, but nonetheless great.