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The Pragmatic Clinical Trials Unit (PCTU) leads and supports clinical trials in which the primary question of interest relates to intervention effectiveness: whether an intervention works under real-life conditions.
It also leads and supports pilot studies for these trials. Currently, the unit focuses on trials of complex interventions, and on trials designed to understand processes explaining effectiveness, but also supports a small number of other pragmatic trials. In addition, the unit leads methodological research relevant to its focus.
The aim of the unit is to lead, support and encourage high quality pragmatic trials and pilot studies particularly where they fit with the research strategies of the two centres with which the unit is linked, or with the methodological interests of the unit.
About us
The PCTU is based in the Centre for Primary Care and Public Health and linked to the Centre for Psychiatry. We have been conducting pragmatic clinical trials since the mid 1990s. We have considerable experience and expertise in primary care, community-based and mental health trials, and particularly cluster randomised trials and trials of complex interventions and behaviour change.
We are a UK Clinical Research Collaboration (UKCRC) registered clinical trials unit.
This unit receives National Institute for Health Research CTU Support Funding. This funding has been awarded to support the unit in developing and supporting NIHR trials.
What does a clinical trials unit do?
The UKCRC defines a clinical trials unit as a unit with overall responsibility for the design, recruitment, data management, publicity and analysis of multi-centred randomised controlled trials or other well-designed studies, working in any disease/topic area. There are more details on their website.
Some trials units are generic, covering all types of trial and disease areas. Other trials units, like the PCTU, have a more specific focus.
Current Projects
The PCTU is currently involved in these projects, which are at varying stages of completion and led by a variety of investigators. For further information please click on the title.
DAPPA - How accurate is spot urinary protein:creatinine ratio (SPCr) and spot albumin:creatinine ratio (SACr) compared to 24-hour protein estimation to assess women with hypertensive disease in pregnancy (HDP) after 24 weeks gestation.
EMPIRE - Antiepileptic drug (AED) management in Pregnancy: An evaluation of effectiveness, cost effectiveness and acceptability of dose adjustment strategies
ENRICH - Enhanced discharge from inpatient to community mental health care (ENRICH): a programme of applied research to manualise, pilot and trial a Peer Worker intervention
EPOCH - Enhanced Peri-Operative Care for High-risk patients (EPOCH) Trial. A stepped wedge randomised cluster trial of an intervention to improve quality of care for patients undergoing emergency laparotomy
ESTEEM: Effect of simple, targeted diet in pregnant women with metabolic risk factors on pre-eclampsia: A randomised trial
FIAT - Financial incentives to improve adherence to anti-psychotic maintenance medication in non-adherent patients – a cluster randomised controlled trial
HABSelect - Hyaluronic Acid Binding for Sperm sELECTion
LSI - What makes online patients' communities effective: An interdisciplinary study informed by network analysis.
MEDAL- Can magnetic resonance imaging (MRI) scan replace or triage the use of laparoscopy in establishing a diagnosis among women presenting in secondary care with chronic pelvic pain (CPP)?
mEsh - Multi-disciplinary Evidence Synthesis Hub (mEsh)
NESS - Effectiveness and Cost-Effectiveness of Body Psychotherapy in the Treatment of Negative Symptoms of Schizophrenia – A multi-centre randomised controlled trial
PACE-UP - Randomised controlled trial of a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45-74 years
PIMS - A multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holesPositioning in Macular hole Surgery (Positioning in Macular hole Surgery)
SALVO - A randomised controlled trial of intra-operative cell salvage during caesarean section in women at risk of haemorrhage
SWAP - A peer-support weight management programme to supplement brief advice in general practice for obese adults from deprived communities
CapaCiTY - Chronic Constipation Treatment pathwaY
EPOS - Effective patient-clinician interaction to improve treatment outcomes for patients with psychosis
HepFree – Chronic viral hepatitis in ethnic minorities. Strategies to prevent the predicted increase in mortality
QuEST – Quality and Effectiveness of Supported Tenancies for people with mental health problems
STOP - Optimising pharmacist-based treatment for smoking cessation
VOLUME - Volunteering in Mental Health Care for People with Psychosis
Other studies
iWIP - Effects of weight management interventions on maternal and fetal outcomes in pregnancy: Individual patient data (IPD) meta analysis of randomised trials and model based economic evaluation
PREP - Development and validation of a Prediction model for Risk of complications in Early onset Pre-eclampsia
START - Systematic Techniques for Assessing Recruitment to Trials: a programme to test recruitment interventions
Completed Projects and Publications
Below is a list of projects that PCTU staff have been involved with in the past. These projects are now completed and resulting publications as well as further information on the trial will be available from links below.
AdjuVIT - Does vitamin D enhance response to treatment in smear positive pulmonary tuberculosis? A double-blind randomised placebo-controlled trial
BELLA - Development, pilot and feasibility study for a chronic obstructive pulmonary disease (COPD) specific version of the Expert Patients Programme (EPP)
Body Psychotherapy - Effectiveness and processes of body psychotherapy in Chronic schizophrenia
Calcitriol trial - Does 1,25-dihydroxyvitamin D3 (calcitriol) enhance corticosteroid activity in steroid-refractory asthma?
ComQuol – A pilot trial to assess the effect of a structured Communication approach on QUality Of Life in secure mental health settings
CONFIDeNT - Control of faecal incontinence using distal neuromodulation
DIALECT - Dialectical-behaviour therapy for people with borderline personality disorders and self harm - a pragmatic pilot trial
The Diabetes Manual - Effectiveness of patient self-managed structured education for type 2 diabetes: a cluster randomised-controlled trial
IRIS - Primary care Identification and Referral to Improve Safety of women experiencing partner violence: a randomised controlled trial
MEDEA - Does the chronic disease self-management programme (expert patient programme) improve metabolic control of diabetes? A randomised controlled trial
Music Therapy - Group music therapy for patients with treatment resistant posttraumatic stress disorder – a pilot randomised controlled trial
OEDIPUS - Can education for South Asians with asthma and their clinicians reduce unscheduled care? A cluster randomised trial and qualitative evaluation
OPERA - Older people's exercise intervention in residential nursing accommodation
PRISMS - A rapid synthesis of the evidence on interventions supporting self-management for people with long-term conditions
RHIVA 2 - Effectiveness of HIV screening in primary care: a cluster RCT and economic analysis
SNS vs PTNS - A randomised mixed methods pilot (phase II exploratory trial) of sacral and percutaneous tibial nerve stimulation for faecal incontinence
WAIT - Parent-determined oral montelukast therapy for preschool wheeze with stratification for arachidonate-5-lipoxygenase (ALOX5) promoter genotype
COPERS - COping with Persistent Pain, Effectiveness Research into Self-management
OViD - Effectiveness of vitamin D supplementation to prevent acute respiratory illness and reduce health care use. The OViD programme encompasses the following trials:
- ViDiAs
- ViDiCO
- ViDiFlu
Other studies
ASAP - Is poor educational attainment in white and Bangladeshi children related to asthma? A study linking health, education and social care datasets
GEM Study (Guided E-learning for Managers ) - Pilot study of a randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee wellbeing and reduction of sickness absence
HiLo - High blood pressure control and lipid Lowering in patients at high cardiovascular risk: a cluster-randomised factorial comparison of educational and protocol
LEZ - Impact of the London Low Emission Zone on Children's Respiratory Health
LPE /Homeless study - Discharge planning for the homeless, examining The London Pathway. Does a GP led discharge team reduce the in-patient burden and improve quality of care?
NHS health checks - NHS Health Checks Evaluation
TOPAS - Measuring and understanding the meaning of chronic widespread pain amongst Bangladeshis in Tower Hamlets, East London
We undertake methodological research emerging directly out of discussions and deliberations around specific trials; this is an important part of the way in which we ensure that we stay at the forefront of the science and execution of pragmatic trials. Important and interesting questions can often be answered in a short time frame with no need for external funding. Senior academic staff also have their own longer term research interests. In particular we have long term interests in cluster randomised trials, pilot and feasibility studies, innovative trial design, and best practice in the design, analysis and reporting of trials. We try to keep a balance between following interesting new avenues and focusing on specific areas.
Theme 1: Cluster randomised trials
Theme 2: Pilot and feasibility studies
Theme 3: Innovative trial design
Theme 4: Best practice in the design, analysis and reporting of trials
Eldridge SM, Costelloe CE, Kahan BC, Lancaster GA, Kerry SM. How big should the pilot study for my cluster randomised trial be? Stat Method Med Res 2015;doi: 10.1177/0962280215588242.
Froud R, Ellard D, Patel S, Eldridge S, Underwood M. Primary outcome measure use in back pain trials may need radical reassessment. BMC Musculoskeletal Disorders 2015;16(1):88.
Hooper R, Bourke L. Cluster randomised trials with repeated cross-sections: alternatives to parallel group designs. BMJ 2015;350:h2935.
Kahan BC, Harhay MO. Many multicenter trials had few events per center, requiring analysis via random-effects models or GEEs. J Clin Epidemiol 2015;doi:10.1016/j.jclinepi.2015.03.016.
Kahan BC, Rehal S, Cro S. Blinded outcome assessment was infrequently used and poorly reported in open trials. PLoS One 2015;10(6): e0131926.
Pinnock H, Epiphaniou E, Sheikh A, Griffiths C, Eldridge S, Craig P, Taylor SJC. Developing standards for reporting implementation studies of complex interventions (StaRI): A systematic review and e-Delphi. Implementation Sci 2015;10(1):42.
Rutterford C, Copas A, Eldridge S. Methods for sample size determination in cluster randomized trials. Int J Epidemiol 2015;doi:10.1093/ije/dyv113.
Rutterford C, Taljaard M, Dixon S, Copas A, Eldridge S. Reporting and methodological quality of sample size calculations in cluster randomized trials could be improved: A review. J Clin Epidemiol 2015;68(6):716-723.
Wright N, Ivers N, Eldridge S, Taljaard M, Bremner S. A review of the use of covariates in cluster randomized trials uncovers marked discrepancies between guidance and practice. J Clin Epidemiol 2015;68(6):603-609.
Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McDonald S, McKenzie JE. The use of the cluster randomized crossover design in clinical trials: protocol for a systematic review. Systematic Reviews 2014, 3:86.
Díaz-Ordaz K, Kenward MG, Cohen A, Coleman CL, Eldridge S. Are missing data adequately handled in cluster randomised trials? A systematic review and guidelines. Clin Trials published online 5 June 2014 DOI: 10.1177/1740774514537136.
Hooper R. Versatile sample size calculation using simulation.Stata Journal 2013;13(1):21-38
Hooper R & Bourke L. The dog-leg: an alternative to a cross-over design for pragmatic clinical trials in relatively stable populations. Int J Epidemiol 2014;43(3):930-936.
Kahan BC. Accounting for centre-effects in multicentre trials with a binary outcome - when, why, and how? BMC Med Res Methodol 2014;14:20.
Kahan BC, Cro S, Doré CJ, Bratton DJ, Rehal S, Maskell NA, Rahman N, Jairath V. Reducing bias in open-label trials where blinded outcome assessment is not feasible: strategies from two randomised trials. Trials 2014;15(1):456.
Kahan BC, Jairath V, Doré CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: An assessment of 12 outcomes from 8 studies. Trials 2014;15(1):139.
Morris TP, Kahan BC & White IR. Choosing sensitivity analyses for randomised trials: principles. BMC Med Res Methodol 2014;14:11.
Rick J, Graffy J, Knapp P, Small N, Collier DJ, Eldridge S, Kennedy A, Salisbury C, Treweek S, Torgerson D, Wallace P, Madurasinghe V, Hughes-Morley A, Bower P. Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials. Trials. 2014;15(1):407.
Weijer C, Taljaard M, Grimshaw JM, Edwards SJL, Eccles MP & Group tOEoCRTC. The Ottawa statement on the ethical design and conduct of cluster randomized trials: a short report. Research Ethics 2014;10(2):77-85.
Diaz-Ordaz K, Froud R, Sheehan B & Eldridge S. A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality. BMC Med Res Methodol 2013;13:127.
Diaz-Ordaz K, Slowther AM, Potter R & Eldridge S. Consent processes in cluster-randomised trials in residential facilities for older adults: a systematic review of reporting practices and proposed guidelines. BMJ Open 2013;3(7).
Hooper R, Diaz-Ordaz K, Takeda A & Khan K. Comparing diagnostic tests: trials in people with discordant test results. Stat Med 2013;32(14):2443-2456.
Hooper R, Froud RJ, Bremner SA, Perera R, Eldridge S. Cascade diagrams for depicting complex interventions in randomised trials. BMJ 2013;347:f6681
Kahan BC. Bias in randomised factorial trials. Stat Med 2013;32(26):4540-4549.
Kahan BC & Morris TP. Adjusting for multiple prognostic factors in the analysis of randomised trials. BMC Med Res Methodol 2013;13:99.
Kahan BC & Morris TP. Assessing potential sources of clustering in individually randomised trials. BMC Med Res Methodol 2013;13:58.
Kahan BC & Morris TP. Analysis of multicentre trials with continuous outcomes: when and how should we account for centre effects? Stat Med 2013;32(7):1136-1149.
Taljaard M, Weijer C, Grimshaw JM, Eccles MP & Group tOEoCRTC. The Ottawa Statement on the ethical design and conduct of cluster randomised trials: precis for researchers and research ethics committees. BMJ 2013;346:f2838.
Choudhury Y, Hussain I, Parsons S, Rahman A, Eldridge S & Underwood M. Methodological challenges and approaches to improving response rates in population surveys in areas of extreme deprivation. Prim Health Care Res Dev 2012;13(3):211-218.
Eldridge S & Kerry S. A practical guide to cluster randomised trials in health services research. Chichester, Wiley, 2012.
Froud R, Eldridge S, Diaz Ordaz K, Marinho VC & Donner A. Quality of cluster randomized controlled trials in oral health: a systematic review of reports published between 2005 and 2009. Community Dent Oral Epidemiol 2012;40 Suppl 1:3-14.
Froud R, Underwood M & Eldridge S. Improving the reporting and interpretation of clinical trial outcomes. Br J Gen Pract 2012;62(603):e729-731.
Kahan BC & Morris TP. Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis. BMJ 2012;345:e5840.
Kahan BC & Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Stat Med 2012;31(4):328-340.
Peacock JL, Sauzet O, Ewings SM & Kerry SM. Dichotomising continuous data while retaining statistical power using a distributional approach. Stat Med 2012;31(26):3089-3103.
Reininghaus U & Priebe S. Measuring patient-reported outcomes in psychosis: conceptual and methodological review. Br J Psychiatry 2012;201(4):262-267.
Teerenstra S, Eldridge S, Graff M, de Hoop E & Borm GF. A simple sample size formula for analysis of covariance in cluster randomized trials. Stat Med 2012;31(20):2169-2178.
Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M & Group tOEoCRTC. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med 2012;9(11):e1001346.
Froud R, Eldridge S, Kovacs F, Breen A, Bolton J, Dunn K, Fritz J, Keller A, Kent P, Lauridsen HH, Ostelo R, Pincus T, van Tulder M, Vogel S & Underwood M. Reporting outcomes of back pain trials: a modified Delphi study. Eur J Pain 2011;15(10):1068-1074.
Nadeem NJ, Taylor SJ & Eldridge SM. Withdrawal of inhaled corticosteroids in individuals with COPD - a systematic review and comment on trial methodology.
Respir Res 2011;12:107.
Eldridge S. Pragmatic trials in primary health care: what, when and how? Fam Pract 2010;27(6):591-592.
Lancaster GA, Campbell MJ, Eldridge S, Farrin A, Marchant M, Muller S, Perera R, Peters TJ, Prevost AT & Rait G. Trials in primary care: statistical issues in the design, conduct and evaluation of complex interventions. Stat Methods Med Res 2010;19(4):349-377.
Eldridge S, Kerry S, Torgerson DJ. Bias in identifying and recruiting participants in cluster randomised trials: what can be done? BMJ. 2009 Oct 9;339:b4006
Eldridge SM, Ukoumunne OC, Carlin JB. The Intra-Cluster Correlation Coefficient in Cluster Randomized Trials: A Review of Definitions. International Statistical Review 2009, 77, 3, 378–394.
Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G. Internal and external validity of cluster randomised trials: systematic review of recent trials. BMJ 2008; 336(7649):876-880.
Who we are
Director: Sandra Eldridge (statistician)
Deputy Director and clinical lead, mental health: Stefan Priebe (psychiatrist)
Senior academic staff
Clinical lead, chronic conditions & primary care: Stephanie Taylor (GP)
Clinic lead, surgical research: Charles Knowles (colorectal surgeon)
Clinical lead, translational research & primary care: Chris Griffiths (GP)
Clinical lead, women's health: Khalid Khan (obstetrician)
Chair in health economics: Anita Patel
Reader in medical statistics: Sally Kerry
Senior lecturer in medical statistics: Richard Hooper
Senior lecturer in medical statistics: Gian Luca Di Tanna
Senior lecturer in clinical trials: Ayesha de Costa
Senior managerial and administrative staff
Head of Operations: Tahera Hussain
Quality assurance manager: Anitha Manivannan
Clinical trials information systems (CTIS) manager: Arouna Woukeu
PCTU administrator: Charlotte Ayton-George
Senior trials managers
Generic: Ann Thomson
Translational health: Bev MacLaughlin
Surgical Unit: Tash Stevens
Women's health: Julie Dodds
The unit also has statisticians, health economists, database programmers, monitors and administrators who each work across a number of projects, and trial managers, trial coordinators, data assistants, research nurses who usually focus on individual projects.
Staff role definitions
We want to ensure researchers get the best possible support from the Pragmatic Clinical Trials Unit and know who is responsible for which tasks within the unit. Different clinical trials units operate differently so this guide applies specifically to the Pragmatic Clinical Trials Unit.
Please see below outlines of some of the roles individuals can play within a trial. You may wish to refer to this guide in combination with the support services available when requesting PCTU support. Staff listed below are employed by the PCTU. Funding for their roles is incorporated in research grant applications, and for successful grants this funding is then paid by the organisation that receives the grant direct to the PCTU to pay these staff.
Data Manager
PCTU data managers: Tom Power, Mike Waring
We offer database design appropriate to the individual needs of each project we support. The data manager will develop appropriate data management strategies for trials and advise on their implementation. They will advise on current regulatory framework regarding data protection and data management procedures in compliance with data protection act and other regulations.
The data manager will advise on suitable database for individual study and set up databases in liaison with chief investigators, statisticians and health economists working on trials. Each database will have integrated data validation checks and full audit trails. Clinical and patient identifiable data are kept on physically separate databases. The data manager will advise on and set up data transfer systems and encryption systems so that all patient identifiable data is encrypted. The data manager will also advise on storage, back-up and archiving of data to ensure databases are regularly backed up to ensure data are safeguarded from accidental loss. In addition to this data management covers the following tasks:Advise on case report form (CRF) design
- Agree with chief investigator time line for database set up and database lock
- With chief investigator, draw up trial data management SOPs.
Health Economist
PCTU health economist: Natalia Hounsome
In some clinical trials, it can be important to compare how much different treatments cost, as well as how well they work. This can be particularly important when two (or more) treatments are equally effective, but differ considerably in their costs. An economic evaluation as offered by our health economist will ensure that all costs (treatment, care and recovery, as well as the costs of prevention, research and training of healthcare personnel) have been considered when the trial results are presented.
The health economist will:
- Develop plans for economic analyses and advise on appropriate data collection
- Collaborate with statisticians and data managers working on trials to ensure appropriate data management systems
- Carry out economic analyses for trials including modelling
- Input into report and publication papers.
Quality Assurance Officer
PCTU QA managers: Anitha Manivannan
The quality assurance officer will train trial staff in PCTU and Joint Research Office's Standard Operating Procedures (SOPs) as relevant to their work, liaise with chief investigators regarding set up trial master files and carry out audits of the trial master file for ongoing quality assurance. They will also ensure compliance with GCP regulations and advise on staff GCP requirements, clinical trial regulatory requirements, adverse event reporting and on PCTU support available.
PCTU Head of Operations
PCTU Head of Operations: Tahera Hussain
The PCTU Head of Operations will act on behalf of the unit director and negotiate with chief investigators over PCTU involvement in trial, agreeing costs and timing. The Head of Operations will liaise with the Joint Research Office over costings for PCTU staff and with grant holding organisation regarding transfer of funds for PCTU support. They manage the PCTU budget and also liaise with R&D departments to ensure necessary contracts are in place.
PCTU Administrator
PCTU administrator: currently vacant
The administrator acts as first point of contact for researchers wishing to collaborate with the PCTU. Day to day admin within the unit covers tasks such as:
- Filter enquiries to the unit, liaising with unit staff as necessary
- Maintain records of all agreements between CIs and PCTU
- Maintain database logging PCTU activity
- Maintain database of active and completed projects supported
- Administrative support for supported projects includes design and maintenance of trial websites for all supported projects.
Further administrative support can be arranged (mainly for trials led from within the Centre for Primary Care and Public Health) to include for example trial correspondence, liaising with research staff or setting up site files as required.
PCTU statisticians: Lauren Bell; Lee Beresford; Claire Coleman; Gordon Forbes; Lauren Greenberg; Brennan Kahan; Vichithranie Madurasinghe; Nadine Marlin; Claire Nightingale; Neil Wright
Statistical support is required at all stages of a project starting with input into protocol development. Further support includes developing analysis plans, performing randomisation or minimisation for trials, liaising with health economist and data managers working on trials, or other studies under the remit of the PCTU, to ensure appropriate data management systems are in place and of course carrying out statistical analyses. Other tasks performed by the statisticians are:
- Carry out sample size/power calculations
- Input into CRF/data capture tools development
- Write detailed statistical analysis plans
- Liaise with data manager to ensure adequate cleaning of final dataset
- Write and check Stata .do files or other appropriate programmes to perform data manipulation and analysis
- Produce reports for the Data Monitoring Committee, Trial Steering Committee or funder as necessary
- Perform any pre-planned interim analysis blinded to treatment allocation. If unblinded analysis is necessary, such analysis will be performed by another statistician in the PCTU.
- Attend trial/study team meetings where possible
- Liaise with data manager and trial manager throughout the duration of the trial to ensure data quality and integrity
- Write a final statistical report
- Authorship on publications arising from projects
- Respond to publication reviewers' comments.
Trial coordinator / Trial manager
PCTU trial managers and coordinators: John Allotey; Sybil Bannister; Lesley Dibley; Julie Dodds; Jessica Gavira; Eion Golden; Wai Yee James; Paula John; Doris Lanz; Bev MacLaughlin; Jacqueline Mansfield; Katie Myers-Smith; Sian Newton; Hana Pavlickova; Sarrah Peerbux; Anna Placzek; Ewelina Rogozinska; Irene Simmonds; Sarah Snuggs; Natasha Stevens; Shiva Taheri; Ann Thomson; Jenn Walker; Karolina Witt
The trial coordinator or manager will maintain general oversight of trial coordinating participating sites as necessary over the full duration of the project. They also manage the trial administration by ensuring that files and documentation is up to date and complete, by keeping accurate written and computerised secure and safe records. They will ensure that all clinical trials procedures are fully compliant with the PCTU's and sponsor's standard operating procedures as applicable to the trial.
They will act as the point of contact for all external and internal agencies and provide efficient day-to-day management of the trial.
This includes but is not limited to:
- Maintain confidentiality and security of patient and staff records
- Recruitment, retention, training, appraisal and supervision of trial team members.
- Establish procedures to ensure adherence to trial protocols and administrative requirements
- Ensure the timely recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management
- Monitor the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems
- Manage the trial budget(s) and maintain the accounts
- Coordinate the preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements
- Liaise with the Trials Steering Committee and Data Monitoring and Ethics Committee with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements
- Provide regular and ad hoc information, both written and verbal, to all the trial participants, funders and sponsors. This could include reports, updates, guidance, proformed commitments and, possibly, a Newsletter.
- Work with the Chief Investigator to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time
- Ensure the inclusion of patient representatives at the appropriate levels and times
- Plan and support meetings and work of the various groups and bodies associated with the trial.
The trial coordinator will also have access to additional advice and assistance from the PCTU's senior trial manager as well as the quality assurance officer. This will be particularly relevant at approval stage, when liaising with various external agencies to gain the appropriate approvals for the project, and in the event of any non-compliance or serious adverse events.
Trial monitor
PCTU trial monitor: Jeanette Hansen
PCTU will monitor and/or audit PCTU supported CTIMP and non-CTIMP trials on a risk-based basis as agreed by the sponsor. The monitoring plan will be agreed by the CI, sponsor and PCTU QA manager prior to study initiation.
Tasks performed by the monitor are:
- Source data verification
- Monitor progress of trial
- Confirm that all adverse events are being documented and reported as necessary
- Check CI adheres to their responsibilities according to GCP and delegates responsibilities appropriately
- Scrutinize trial related documents
- Examine research staff on their knowledge of the protocol
- Ensure that the trial is being conducted according to GCP, clinical trial regulations and sponsor requirements.
- The purpose is to verify that reported trial data is correct, complete and verifiable (ICH GCP 1.38 and 5.18.1). Findings are reported to the PCTU QA manager and sponsor via a monitoring report.
What PCTU does
What is a clinical trial?
We use the definition of a clinical trial as proposed by the International Committee of Medical journal editors:
"Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. By 'medical intervention' we mean any intervention used to modify a health outcome. This definition includes drugs, surgical procedures, devices, behavioural treatments, process-of-care changes, and the like."
This definition is wider than other definitions, some of which restrict the use of the word 'clinical' to trials in which medicinal products are being investigated. Many of the trials the PCTU leads and supports are not trials of investigational medicinal products.
What is an investigational medicinal product (IMP)?
Article 2 (d) of the EU Clinical Trials Directive 2001/20/EC provides the following definition for an IMP:
"a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form."
The PCTU does lead and support trials of investigational medicinal products but these are in the minority.
Trials led by the unit
The unit leads trials conducted within the Centre for Primary Care and Public Health and the Centre for Psychiatry.
Trials linked to the unit
These include trials led from elsewhere in Barts and The London School of Medicine and Dentistry or Barts Health NHS Trust, and trials led from outside these organisations. The last category includes multi-centre trials led from other centres, where the unit may sometimes have joint responsibility for aspects of trial design and analysis together with another clinical trials unit. Trials from outside the Centres of Primary Care and Public Health and Psychiatry can be linked to the unit if they are trials of effectiveness fitting broadly with either the research strategies or methodological interests of the unit.
How to obtain support
Initial request
The initial request has to be received at least 12 weeks before the intended application's submission date (outline application if applicable).
Level of support
Usually, the PCTU would expect to provide all the services listed under details of support available, dependant on the potential costs for support and the capacity of the PCTU. In some cases the level of support will depend on the costs involved and the capacity of the PCTU. We are able to offer bespoke advice tailored to the individual needs of each supported project but will only engage in high quality, methodologically sound trials where we also have academic input. All trials supported by the PCTU must adhere to relevant Standard Operating Procedures already in place.
Once the trial chief investigator and the PCTU manager are in agreement about the level of support and costs, approval for support must be gained in writing (usually by email) from the PCTU director or manager. This approval must be gained before any funding applications are submitted and must include full details of the support and cost agreed upon.
Support available
Support can be accessed during protocol development and during the trial itself. Support accessed during protocol development is not charged for and must be negotiated depending on PCTU capacity. This support is important in relation both to successful funding and successful projects and we encourage all researchers to take full advantage of the support offered this stage.
We often encourage researchers to also link with the London Research Design Service for further support in developing their application.
Services accessed after trial funding is secured must all be adequately costed and agreed beforehand. We will expect to recover the true costs of our engagement in a study in terms of staff costs and consumables.
Such funding supports staff employed by the unit to work across a range of trials, such as data managers, statisticians, health economists, quality assurance officers, administrators and the unit manager.
Areas in which the unit supports trial are:
In protocol development
- Statistical advice prior to submission
- Advice about sample size calculation
- Advice about statistical analysis plan in protocol development
- Advice about trial design
- Other field specific advice about:
- health economics analysis
- data management
- quality assurance
At Set up and during trial
- Randomisation service
- Statistical Services
- Statistical analysis planning
- Statistical advice and analysis
- Contribution to report writing
- Data Management
- Data management advice
- Database set-up
- Quality Assurance
- Advice on adverse event reporting
- Advice on clinical trial regulatory requirements and quality assurance
- Access to and advice about CTU endorsed SOPs
- Health Economic Services
- Economic evaluation
- Contribution to report writing
- Administrative support
- Senior Statistician advice and presence on steering committees
- Senior Health Economist advice and presence on steering committees
- Senior trial management advice
- Trial coordinator support
- Trial monitoring
The unit does not provide advice that can be accessed elsewhere. For trials led from Barts and The London School of Medicine and Dentistry, detailed advice about research governance, ethical approval and MHRA procedures please see Joint Research Management Office (JRMO) of Barts Health NHS Trust and Queen Mary, University of London.
SOPs & CI responsibilities
CI responsibilities
The chief investigator is responsible for negotiating level and cost of support and for gaining approval for support by the PCTU (as specified in PCTU support), and for clearly specifying the role of the PCTU and corresponding financial implications in any funding application.
The PCTU works to a number of SOPs specific to the PCTU. The chief investigator is responsible for ensuring that trials linked to the PCTU follow these SOPs. Compliance will be monitored by the PCTU. The responsibilities of the chief investigator as detailed in the ICH Good Clinical Practice guidelines are listed below:
- Qualifications and agreements (GCP, delegation of trial-related duties)
- Adequate Resources – time, funding, demonstrate ability to recruit (via pilot etc)
- Medical care of trial subjects
- On-going communication with REC/MHRA throughout trial (amendments, annual reports etc)
- Ensure full compliance with protocol and document deviations and submit amendments to REC
- Investigational Product (if applicable) - responsible for IMP accountability at site/s (can be assigned to appropriate pharmacist)
- Randomization Procedures and Unblinding – responsible for following trial's randomization and blinding/unblinding procedures (if applicable)
- Informed consent – responsible for following GCP guidelines on informed consent
- Records and Reports – follow GCP guidelines on CRF and source documentation, maintenance of trial documentation, financial agreements and archiving
- Progress Reports – provide written summaries to REC (annually or more frequently if requested) and sponsor and REC regarding substantial changes to trial
- SAEs - responsible for ensuring all SAEs reported to sponsor ('Sponsor' is an individual, company, institution or organisation which takes responsibility for the initiation and management of the clinical trial)
- Premature Termination or Suspension of Trial – Responsible for ensuring trial subjects, institution sponsor and REC are promptly informed if trial ends prematurely or is suspended
- Final Report – ensure that final report provided to institution, REC, regulatory authorities and sponsor
Standard Operating Procedures
- PCTU SOP DM 02 CRF Design v2.0
- PCTU SOP DM 04 Data Entry, Quality Control, Data Extraction and Database lock v2.0
- PCTU SOP DM 05 Electronic Data Security v3.0
- PCTU SOP DM 06 eCRF-Database Application Design and Development v2.0
- PCTU SOP DM 07 Database Validation v2.0
- PCTU SOP DM 08 Database Application Versioning and Change Control v2.0
- PCTU SOP DM 09 Business continuity - Backup and disaster recovery v2.0
- PCTU SOP DM 10 Database Application Documentation v2.0
- PCTU SOP DM 11 Data Transfer v2.0
- PCTU SOP GA 01 PCTU Trial Support Proceedure (for CIs) v5.0
- PCTU SOP GA 02 PCTU Filtering System for Trial Support Enquiries (PCTU Staff) v5.0
- PCTU SOP GA 03 Event Organising v3.0
- PCTU SOP GA 04 Agreement between PCTU and JRMO regarding costing of PCTU v2.0
- PCTU_SOP_HE 01 Health Economics Analysis v3.0
- PCTU_SOP_IT 01 Clinical Trials Systems Access v2.0
- PCTU SOP QA 01 Pragmatic CTU SOPs v4.0
- PCTU SOP QA 02 QA and QC System v6.0
- PCTU SOP QA 03 Document Control v5.0
- PCTU SOP QA 04 Monitoring of PCTU Supported Research Projects v2.0
- PCTU SOP QA 05 Statistical and Health Economic Analysis QC v2.0
- PCTU SOP QA 06 Staff Training v3.0
- PCTU SOP QA 07 Preparing for regulatory inspections v1.0
- PCTU SOP SP 01 Statistical Analysis v4.0
- PCTU SOP TC 01 Trial Close Out v2.0
- PCTU SOP TC 02 Archiving Research Projects v3.0
- PCTU SOP TM 01 Trial Master File and Investigator Site file maintenance v6.0
- PCTU SOP TM 02 External Trial Oversight Committees v3.0
- PCTU SOP TM 03 IMP management and labelling v4.0
- PCTU SOP TM 04 Informed Consent v2
- PCTU SOP TM 05 Adverse Event Reporting for CTIMPs v2.0
- PCTU SOP TM 06 Adverse Event Reporting for non-CTIMPs v2.0
- PCTU SOP TM 07 Document Completion, Transport and Storage v2.0
- PCTU SOP TM 08 Reporting of Amendments and Deviations v2.0
- PCTU SOP TM 09 Site Initiation and Staff Training v3.0
- PCTU SOP TM 10 Handling Trial Correspondence v2.0
- PCTU SOP TM 11 Effective Trial Management v3.0
- PCTU SOP TM 12 Annual progress, safety and end of trial reports v3.0
- PCTU SOP TP 01 Protocol development v4.0
- PCTU SOP TP 02 Statistician Involvement v5.0
- PCTU SOP TP 03 Randomisation and blinding v5.0
- PCTU SOP TP 04 Clinical Trial Risk Assessment v2.0
- PCTU SOP TP 05 Trial Management - The Approval Processt v2.0
There are a number of other sites which researchers may find useful.
The MRC/DH clinical trials toolkit provides practical help for those trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004, which implement the EU Clinical Trials Directive in the UK.
An online module has been added to IRAS to guide new users through IRAS. The module, which is free, explains how IRAS is structured and guides users through how to prepare and make applications using IRAS.
Other Useful Information
Clinical Research Zone - The Guardian
European Agency for the Evaluation of Medicinal Products
Institute of Clinical Research
MRC Guidelines for Good Clinical Practice
National Research Ethics Service for guidance on ethics applications including a CV template
Queen Mary, University of London Information Security
Understanding Clinical Trial booklet
We also recommend researchers contact the Research Design Service.
For further information and to submit a request see www.rdslondon.co.uk
(Please select 'Queen Mary, University of London' as RDS co-ordinating centre at the bottom of the form if you submit a request.)
Pragmatic Clinical Trials Unit
c/o Centre for Primary Care and Public Health
Yvonne Carter Building
58 Turner Street
Whitechapel, London E1 2AB
Telephone: + 44 (0)20 7882 3449
Facsimile: + 44 (0)20 7882 2552
Please note the PCTU does not recruit trial participants. If you wish to participate in any of the trials we support please contact the trial team directly. For contact details see trial information in our research section.
News & Events
Training Courses
Inside a Clinical Trials Unit
This course will be of interest to new principal investigators and other researchers who have not previously worked closely with a Clinical Trials Unit (CTU), and who want to learn more about the design and conduct of pragmatic clinical trials and the nature of CTU involvement. The course is an immersive experience including observation of real-life trial processes and the work of CTU staff, and one-to-one time spent with knowledgeable tutors.
Registration on one of our 3-day taught courses (Introduction to Design, Conduct and Analysis of Pragmatic Clinical Trials, or A Practical Guide to Cluster Randomised Trials (Introductory Course)) is also included in the price. The course will be based at the Pragmatic Clinical Trials Unit (PCTU) at Barts & The London School of Medicine & Dentistry.
In addition to the 3-day taught course, the total time commitment amounts to no more than 1 hour a week, spread over a period up to one year, though this can be scheduled flexibly to suit your needs. You will benefit from:
- a lead tutor who will be your main point of contact with PCTU, who will help you to plan a series of opportunities (at least 10 hours in total) for observing meetings and other PCTU activities encompassing the complete natural history of a trial;
- 6 one-to-one 1-hour sessions with your lead tutor, spread over the year, to consolidate what you have learned and discuss issues in depth;
- 6 one-to-one 1-hour sessions, spread over the year, with a specialist tutor from one of four PCTU teams (depending on the area you particularly want to focus on): statistics, data management, quality assurance or trial management.
Some of your time will be devoted to self-directed learning: your lead tutor will give you resources and practical tasks suited to your study programme, and there will be space in PCTU for hot-desking and engaging more fully with the Unit.
You can start the course at any time during the year, but the number of places at any one time is very limited, and you will need to give us at least 1 month's notice of your intended start date, so we advise that you contact us as early as possible if you are interested in joining.
Cost for those booking before end of June 2016:
QMUL staff: £2,500
External: £2,800
CONTACT (also for information about our 3-day taught courses, including dates)
Website: http://www.blizard.qmul.ac.uk/pragmatic-clinical-trials-unit.html#news-events
Current developments in cluster randomised trials and stepped wedge designs
This meeting will consist of a series of short talks and discussion about new perspectives for the design, the analysis and the reporting of cluster and stepped wedge trials.
We will reply with decisions regarding abstracts by Sept 29th 2016.
Old Library at Queen Mary University
29th November 2016: 10:30am-4pm
Link for online registration and payment:
Registration ends: 14thNovember 2016
Cost: £25 includes Lunch
Pragmatic Clinical Trials Unit
PCTU Newsletter
30 June 2015 - Prof Sandra Eldridge awarded Honorary Fellowship of Royal College of General Practitioners
12 July 2013 - Publication checklist proposed to boost rigor of pilot trials
A Practical Guide to Cluster Randomised Trials in Health Services Research
Sandra Eldridge and Sally Kerry have published a book 'A Practical Guide to Cluster Randomised Trials in Health Services Research' with Wiley & Sons Ltd. The book provides a concise guide to running cluster randomised trials in a health care setting; covering ethics, recruitment, piloting, design, reporting, systematic reviews, process evaluations and monitoring with introductions to analysis, sample size calculations, and health economics. The book is available to purchase from Wiley.


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This story breaks my heart. I can't imagine.....
As for that damned fence, does it really matter how tall it was? Do you know in Yellow Stone there are NO fences to separate you from the wild animals
From what others have said on here, from pictures and from a video the fence description has been off. I've been to Yellowstone, this summer and I know that. You can also walk right up to boiling hot geysers. .
I think its fair to say that everything except condolences have been said enough times in this thread.
I know it may look like I was being like a bitch, but that's only because I was acting like a bitch.
"I asked Mom if I was a gifted child...she said they certainly wouldn't have paid for me."
[Insert a witty saying here!]
Colin (11/07), Corbin (1/11), and Lorelei due 4/13!
R.I.P Maddox ♥
Rachael (18) ~ Mommy to Anabelle (2)
Platinum Boobie Award ( . Y . )
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WordPress – Update Theme, Fixes three small problems with the layout and Plugins to install - Project 6
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Foundation grantmaking focuses on four major program areas.
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The Southern Cape Land Committee was established in 1987 and works with rural communities, farmworkers and farm dwellers, and small-scale farmers to create the conditions for agrarian reform. Past support assisted the Southern Cape Land Committee to educate people on farms about their rights and how to access them. Support was provided to eight rural community advice offices and 35 farmworker committees, representing the interests of over 2,200 farmworkers and farm dwellers. This grant will support the Southern Cape Land Committee to support community advice offices and farm and forestry workers in rural parts of the Eastern and Western Cape provinces. The support will include assisting communities to organize themselves and understand their rights so that they can engage decision makers on accessing these rights, conducting research to better understand the living and working conditions of poor people on farms, and producing and disseminating information that enables people to access their rights.
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*Note: This program area previously included support to organizations working in Russia, and such support is detailed in the Foundation's grants database. However, in 2015, the Charles Stewart Mott Foundation was included on a list of organizations that the upper house of the Russian parliament recommended designating as "undesirable." We therefore concluded that the best course of action was to discontinue our support in Russia. See the Foundation's statement regarding this development for more information.
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The Hidden Power of Speaking in Tongues
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Product Description
In The Hidden Power of Speaking in Tongues, we are once again reminded and carefully taught about the incredible possibilities available in speaking in tongues. This spiritual gift, much maligned and controversial in our day, was a vibrant and necessary part of the worship and intercession of the early Church. It is an experience that hungry believers long to rediscover here in the twenty-first-century Church, as millions search for a more meaningful understanding and relationship with their Lord.
As he softly removes the mystique and mystery overshadowing this glorious gift, Chavda challenges the Body of Christ to pursue afresh the secret dynamic of speaking in tongues.
Product Information
|Format: Paperback
Number of Pages: 176
Vendor: Destiny Image
Publication Date: 2003
|Dimensions: 9 X 6 (inches)
Availability: Expected to ship on or about 08/10/16.
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peteFARMINGTON HILLS,MIAge: Over 65Gender: female5 Stars Out Of 5HIDDEN POWER OF SPEAKING IN TONGUESApril 25, 2016peteFARMINGTON HILLS,MIAge: Over 65Gender: femaleQuality: 5Value: 5Meets Expectations: 5This book is a must for all believers. I was at a prayer shut-in on July 10, 2009 and God answer my question while I was reading this book from that shut-in. I started Praising God as I was reading chapter 2 as the words seem to lift off the page and click in my spirit, giving me my answer. This book is powerful. I thank God for Pastor Chavda , giving him the knowledge for writing this book. It took 4 years from that shut-in to get my answer but 1 day is as 1000 years with God. My prayer language have grown from reading and understanding this gift and the deeper things of God, This book will bless you if you want to go deeper in God.
Debra Adkins5 Stars Out Of 5May 7, 2009Debra AdkinsThis book is very powerful. I think it explains in laymans terms the awesome gift of speaking in tongues. I think it will help others get rid of the fear or intimidation felt sometimes in a service where the Holy Spirit has reigned down.
Art Henderson5 Stars Out Of 5February 29, 2008Art HendersonHidden Power of Speaking in Tongues has redirected my religous life in a new direction. The very thought of praying in tongues, speaking in Heaven's language is excciting and this book has been an insperation.
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Outrageous Advertising That's Outrageously Successful: Created for the 99% of Small Business Owners Who Are Dissatisfied with the Results They Get Paperback – May 1 2009
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Book Description
OUTRAGEOUS ADVERTISING THAT'S OUTRAGEOUSLY SUCCESSFUL gives you the secrets to succeeding with the most effective advertising of all--OUTRAGEOUS advertising.
Rich with examples and stories showing exactly how to implement a successful OUTRAGEOUS program, this book cracks the code on getting a return on your advertising dollars--an OUTRAGEOUS return! Glazer points out that the biggest advertising day of the year, the Super Bowl, became that way because people expect to see OUTRAGEOUS ads. OUTRAGEOUS ads get attention, and this book proves you can do it without the Super Bowl ad.
OUTRAGEOUS ADVERTISING THAT'S OUTRAGEOUSLY SUCCESSFUL presents the clear fact that OUTRAGEOUS advertising works because of its ability to get you noticed, and then it offers you specific OUTRAGEOUS marketing principals, and finishes by taking you into the OUTRAGEOUS idea factory.
This book is graphically rich with examples from Glazer's years in the trenches doing exactly this kind of advertising for his Baltimore menswear store, Gage Menswear, as well as examples from many other industries. It includes resources cited throughout the text for you TO find more information or access to promotional materials. This is not a book about theory or generic branding. This is simply about creating OUTRAGEOUS results with OUTRAGEOUS ADVERTISING THAT'S OUTRAGEOUSLY EFFECTIVE. It's easy if you know how!
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This is really a decade-spanning swipe file of the very best marketing campaigns Bill Glazer has seen and done.
This book is messy in the same way that good marketing is messy. It's not a book about brand-building or graphic design, it's a book about getting attention, surprising and delighting customers with provocative messages and promotions. It's sort of like Bill dumped the contents of his filing cabinet on the floor and started going through them one by one.
Most of the examples in this book are direct mail. Direct mail is a whole lot less fashionable than Facebook and online video, but done properly it commands far more attention. And since the size of most peoples' "junk mail" pile is at an all time low, mailing to existing customers and high-probability prospects is a strong bet. No sensible person can go through this book and not find a great idea they can use.
This is outstanding for retailers because of Bill's retail background. Many examples in this book are from retail.
As for my own audience, online marketers, it's good for us because it FORCES you to consider things you would never otherwise think about. Just by executing one or two of these ideas you'll put yourself in elite company.
Ideas in this book include examples of making web pages more outrageous with documented response percentages; sending things like popcorn and lunch bags and birthday specials. Placemats and x-rays and collections of winning headlines.
The only drawback is that the print in the book is sometimes fuzzy and you can't read the fine detail in the pictures. Fortunately, however, he offers a CD with all the exhibits.
Bill, thanks for putting out such a great addition to my swipe file.
Perry Marshall
We've all seen brilliant TV commercials which are so memorable, we will never forget them. The problem is, many people cannot recall what was being sold. That is a problem which Glazer addresses, although not regarding TV ads. He shows how to be different enough to be noticed, without being bizarre to the point of distracting the prospects.
If you want to have people notice you, you can't beat this book or even The Ultimate Sales Letter: Attract New Customers. Boost your Sales. if you're considering a direct mail campaign. For general theory of setting yourself apart from the pack, check out 10-Ways To Stand Out From The Crowd by Connie Podesta. So what do you use to get all these ideas written on napkins and rattling around in your brain into a usable platform? I use ThoughtOffice Brainstorming and Creativity Software, which asks you questions which you never even knew you needed to answer.
I do think this book was about 25% longer than it needed to be. It became a little repetitive, but not obnoxiously so. Some people would probably benefit from having these good ideas drummed into their heads a little. Also, I think he makes it all seem a little easier than it actually is. Million dollar ideas don't just pop up every day, but with this book you have a better shot.
At the beginning Bill gives you a lot of background on the effective ways to use advertising to generate customers. Bill's an advocate of direct mail and he shows you several examples of campaigns that have worked for other people. But, rather than talking about advertising theory, Bill provides you real examples of mailings that business people have used to promote their business. Anyone can tell you what should work. Bill gives you examples that did work and tells you why.
You've probably seen ridiculous attempts by advertisers to get attention that leave you asking, "What?" In this book Bill dissects effective advertising campaigns to show you how to turn the attention you get from the outrageous and into buying activity. In chapters 5-8, Bill gives you the essential components to make your advertising effective as well as several ideas you can select from to boost your response. This book includes several split test examples so you can see the results of the letter mailed one way compared to the results of another method.
Appropriately, there's an entire chapter about follow-up campaigns. Outrageous advertising isn't all about one mailing and then done. It's about persistent communication with your customer. And, Bill's book gives you several examples of follow-up letters that are equal parts outrageous and easy to create.
I'm so glad to have this book. It'll be a huge short-cut when I'm looking for ideas to get attention and a checklist for the elements I must include to turn the attention I generate into new customers. I recommend that you add this book to your library. It'll be one of those books that pays dividends to you for years.
However, what I like best is that Bill is not just some ordinary consultant or guru who only tells you how to do it. He's actually done it all himself! Bill has owned the number one men's retail store in Baltimore and many of the examples are from his very successful campaigns.
Everyone will enjoy these fun filled, exciting marketing ideas that will make their marketing stand out from the crowd.
On a personal note, I have known Bill for several years and have waited patiently to read this book. Bill has given us one of the biggest marketing swipe files that exists, with the best of the best marketing ideas I personally have seen. Bill even gives us a free CD with examples of all of these successful marketing pieces. Congratulations to Bill on an outstanding book.
Because there are more proven, effective, immediately useful advertising tips and examples in this book than any other I can remember.
Advertising rookies will benefit from this because, if you read it early in your business career, you'll have far, far fewer bad habits to unlearn later.
Advertising veterans (like me) can pick up a half dozen new tricks every chapter on such topics as direct mail, offers, deadlines, headlines, premiums, holiday promotions, and sequential mailings.
Bottom line: If you have to feed your family tomorrow with the ads you write today, get this book.
Three takeaways:
1. Understand that there are 3 possible responses to every ad: "yes," "no," and "maybe later."
Key corollary: When you pay attention to people who say "maybe later," your profits will soar.
How to do it?
Follow up multiple times and offer valuable information that educates, informs, and ingratiates your business with your prospects. You can deliver marketing-based information to convert more "maybe" prospects into "yes" customers via web pages, email, direct mail, tele-seminars, webinars, brochures, articles, etc.
2. Think of your business card as a mini sales letter. Because it is one.
Your business card must stand out or get thrown out. Don't scrimp on this and get the $25 "name, rank, and serial number" type cards from Vista print.
Instead, put some thought into your business cards. What would you include on your cards if they were the only chance you had to impress prospects enough to call you? If you're stuck, Google "creative business cards" to get ideas.
3. You can't sell to people who don't know you exist.
This is actually the thesis of the book. Anything you can do to stand out and be memorable (within reason) will improve your advertising. Examples from the book include:
* mailing a sales letter inside a coconut, a bank pouch, a wastebasket, etc.
* personalizing your sales letters wherever possible with the prospect's name
* taping a rubber band, a nickel, or other "grabber" atop your sales letters
* tying your promotions to holidays, current events, prospects' birthdays, etc.
No, you don't have to dress up in a straitjacket and imitate the local used-car dealer on late night cable. But yes, you do have to get noticed to get customers.
Not only can you do it with your dignity intact, but you can use Outrageous Advertising to make your business fun again. That's important. Just as most cars rust out before their engines wear out, most small business owners tire of their businesses before their customers and markets tire of them.
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text:
About Conditions Treated
Plantar Fasciitis
Plantar fasciitis is a painful inflammatory process of the plantar fascia, a thick fibrous band of connective tissue originating on the bottom surface of the calcaneus (heel bone) and extending along the sole of the foot towards the five toes.
Probably the most common complaint presenting at our centres, pain in the arch or heel often indicates inflammation of the long band of tissue under the foot (the plantar fascia). It can cause sharp pain and discomfort in either the mid arch region or at the inside heel, and less commonly the outside heel. It frequently causes pain upon rising from rest (especially first thing in the morning) and can progress to agony by the end of the day. Although plantar fasciitis is the most common cause of this pain, it must be skilfully differentially diagnosed from other conditions via a thorough history taking and physical examination.
Assessments are guided towards finding the cause of the injury, often mechanical in origin. Treatment of plantar fasciitis may include one or a number of: stretching, footwear modification, orthotic devices, specially placed padding, dorsiflexion night splints, ice, and either topical or oral anti-inflammatories.
Plantar fasciitis is often treated using orthotics or plantar fasciitis splints.
Conditions Treated
range of foot ailments treated
- About Conditions Treated
- Where Is Your Pain?
- Achilles Tendinopathy
- Anterior Knee Pain
- Arch Pain
- Bunions
- Diabetic Footcare Tips
- Feet in Down Syndrome
- Feet in Stroke Patients
- Footcare & Diabetes
- Forefoot Pain
- Fungal Nails
- Heel Pain / Plantar Fasciitis
- Ingrown Toenails - Nail Surgery
- Leg Length Discrepancy Following Joint Replacement Surgery
- Metatarsalgia
- Mortons Neuroma
- Paediatric Lateral Foot Pain - Is It Iselin's?
- PinPointe FootLaser - Nail Fungus Treatment
- Plantar Fasciitis
- Plantar Plate Tear
- Plantar Warts
- Posterior Tibial Tendon Dysfunction
- Pregnancy and Your Feet
- Rheumatoid Arthritis
- Sesamoiditis
- Sever's Disease
- Shin Splints
- Smelly Feet (Bromhidrosis)
- Tailor's Bunions
- The Truth About Heel Pain
- Shoe Fitting Guide
- Children's Feet
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Christensen Glacier (Bouvet Island)
From Wikipedia, the free encyclopedia
Christensen Glacier is a glacier which flows to the south coast of Bouvet Island (Bouvetøya), 1 nautical mile (2 km) east of Cato Point. It was first charted in 1898 by a German expedition under Karl Chun, and recharted in December 1927 by a Norwegian expedition under Captain Harald Horntvedt. It was named by Horntvedt after Lars Christensen, the sponsor of the expedition.[1]
- ^ "Christensen Glacier". Geographic Names Information System. United States Geological Survey. Retrieved 2011-11-11.
This article incorporates public domain material from the United States Geological Survey document "Christensen Glacier" (content from the Geographic Names Information System).
Coordinates: 54°28′S 3°24′E / 54.467°S 3.400°E
|This Bouvet Island location article is a stub. You can help Wikipedia by expanding it.


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To The Editor:
I know I will probably take a lot of criticism for this letter but sometimes you just have to write what you feel. Right now I'm not feeling very good about Washington as a community.
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Hi everybody,
On certain pages with a gallery I have an error loading the language file. The English one. I already uploaded it again, cleared the cache etc. but that doesn't help.
I use the Amazon Cloudfront CDN. When I disable that the error is gone.
But I want to use the CDN. What can I do?


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Select your hotel from the list. Or search for hotels on the City page of Putzbrunn
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- CareerXactCo-Founder, 1999 - present
- ClearFitCo-Founder, 2007 - present
I'm a board member of EO/YEO (Entrepreneurs' Organization). Awarded U.S. Patent No. 7,502,748 B1 for for job matching system and method; Other Patents Pending.
Chasing Stars: Why the Mighty Red Sox Struck Out — HBS Working Knowledge
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Find employees who fit and employee hiring tool | ClearFit
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Are You Charging Enough for Your App?
GUEST MENTOR Ben Baldwin, CEO of ClearFit: Charging customers for your product not only makes you money, it also cues who should pay for it,
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ClearFit - AngelList
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Recruiter Recruiters Recruiting Recruitment. Recruiters. Latest Activity; Forum; Articles; News; Recruiter Today; Whitepapers; Glossary. Job
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4 Mistakes Big Companies Make When Selling to Small Businesses
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Dear Friend: Sorry. My heart says yes, but my schedule says no.
Dear Friend, Thanks for reaching out and connecting. It is likely that you, your idea, your company, or your proposition is awesome. U
On Startups by Dharmesh Shah
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Finding Employees with the Owner of Infinity Asset Solutions
In my interview today, we are finding employees with Josh Sugar, whom I met through my work with Entrepreneurs Organization.
Hiring Mistakes: How to Avoid Them and What to Do If You Don't
Ever hired someone who didn't turn out as expected? Did that job candidate become one of your hiring mistakes; turning off your best custom
Hiring tool with critical interview questions and answers
ClearFit online hiring tool finds job applicants, identifies the best candidates and reveals critical interview questions and answers.


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Jan Christiaan Smuts, The Man Who Invented Holism
Friday 29th July 2016
E-Cigarettes May Have Their Own Health Risks
Wednesday 27th July 2016
Take Time To Think Of The Universe & Human Consciousness
Friday 22nd July 2016
Quantum physics has always been a source of mystery and delight. It defies common sense yet we have learned to manipulate these strange phenomena.Hey, is this even the right question? I think we should be saying that "common sense" defies physics. "Common sense" says that the mind is in the brain; aspirin kills pain; cancer is a consequence of genes; old age is a "disease" of wearing out par ...[click to continue]
Picture Postcard from Prof's African Travels
Friday 15th July 2016
Does Gut Health Affect Autism?
Wednesday 13th July 2016
Albert Abrams Discovers Human Sensitivity to Earth's Magnetic Field
Friday 8th July 2016
Humans Have an On-Board CompassCan humans detect the Earth's magnetism in their cells? Of course not, say the experts. Is the Sun the center of the solar system? Of course not, said the experts. Does washing your hands after touching corpses help avoid the spread of disease? Of course not, said the experts. Can food allergies make you ill? Of course not, said the experts. So I would just yawn at the "science" that says of course not… without them even looking! But I have a particular reason for supposing that humans are, indeed, very sensitive to the Earth's geomagnetic field. Those of you who have read my sensational book ...[click to continue]
The Impact & Dangers of Antibiotics on Your Child
Thursday 7th July 2016
Dangers of Antibiotics Impact Children's Gut HealthNew research from Aalto University in Finland followed more than 1,000 children with the DIABIMMUNE project and tracked their overall gastrointestinal health in relation to antibiotic use. Several ...[click to continue]
Renegade Gardening Resources Instead Of Who Is President
Friday 1st July 2016
Gardening, especially public, renegade gardening, is one of the most important things conscious and awakening people can do right now to affect global change in favor of good health, a sound environment, and personal liberty—Alex Pietrowski, Staff Writer, Waking TimesThe following three paragraphs are directly from RealFarmacy.com. As someone who loves gardening resources, the message resonates well with me!
The most effective change-makers in our society aren't waiting around for a new president to make their lives better, they're planting seeds, quite literally, and through the revolutionary act of gardening, they're rebuilding their communities ...[click to continue]
How Benefits of Nitric Oxide Can Help Your Heart
Wednesday 29th June 2016
How To Better Your Life
Friday 24th June 2016
Can You "Catch" Obesity?
Tuesday 21st June 2016
Is Obesity Contagious?You know my standing on the health of your gut microbiome. An unhealthy gastrointestinal system wreaks havoc on every other aspect of your health. Obesity may be one of many conditions that's affected. Could microbes in your gut create contagious obesity? Scienc ...[click to continue]
Is Medical Error the 3rd Leading Cause of Death?
Friday 17th June 2016


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|Paizo Pathfinder® Paizo Games
|Pathfinder Adventure Card Game Pathfinder Roleplaying Game Pathfinder Adventures Pathfinder Campaign Setting Pathfinder Player Companion Pathfinder Accessories Pathfinder Miniatures Pathfinder Fiction Pathfinder® Society™ Pathfinder Roleplaying Game Compatible Products Pathfinder Apparel & Gifts Pathfinder Licensed Products
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Pathfinder Society Scenario #7–23: Abducted in Aether (PFRPG) PDF
Pathfinder Player Companion: Legacy of Dragons (PFRPG)
Pathfinder Player Companion: Blood of Angels (PFRPG)
Paizo Inc.(based on 4 ratings)
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Touched by benevolent beings of the good Outer Planes somewhere in their ancestry, aasimars are viewed with either awe or fear by all who know of their celestial heritage. Hailed as scions of angels at best or otherworldly bringers of heavenly destruction at worst, there is no doubt that aasimars hold a very special place in the world of mortals, and all know to be wary of their actions in the presence of an aasimar.
Blood of Angels presents a player-friendly overview of the aasimars of the Pathfinder campaign setting, as well as new rules and information to help players create unique and interesting celestial characters for any type of game.
Written by Amber E. Scott
Each bimonthly 32-page Pathfinder Player Companion contains several player-focused articles exploring the volume's theme as well as short articles with innovative new rules for social, magic, religious, and combat-focused characters, as well as traits to better anchor the player to the campaign.
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Product Reviews (4)
Paizo Blog: A Legacy Is So Much More Than Blood,
Clarification Request: Kapenia Dancer armor proficiencies,
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Store Blog: Come Now Miss Moneypenny!,
Hellknight Armor Training and Advanced Armor Training,
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Pathfinder's Mischievous Goblins Return to Wreak Havoc on Free RPG Day in New We B4 Goblins Module,
Trapdoor Technologies Releases Officially Licensed Digital Toolset for the Pathfinder Roleplaying Game,


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Well, it's official now: John Kiriakou, the former CIA operative who affirmed claims that waterboarding quickly unloosed the tongues of hard-core terrorists, says he didn't know what he was talking about.
Kiriakou, a 15-year veteran of the agency's intelligence analysis and operations directorates, electrified the hand-wringing national debate over torture in December 2007 when he told ABC's Brian Ross and Richard Esposito in a much ballyhooed, exclusive interview that senior al Qaeda commando Abu Zubaydah cracked after only one application of the face cloth and water…
Now comes John Kiriakou, again, with a wholly different story.
More from Ken Silverstein:
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In Havana, the past year has been marked by a parade of bold-faced names from the north — John Kerry reopening the United States Embassy; Andrew Cuomo bringing a delegation of American business leaders; celebrities ranging from Joe Torre, traveling on behalf of Major League Baseball to oversee an exhibition game between the Tampa Bay Rays and the Cuban national team, to Jimmy Buffett, said to be considering opening one of his Margaritaville restaurants there. All this culminated with a three-day trip in March by Barack Obama, the first American president to visit Cuba since Calvin Coolidge in 1928. But to those who know the city well, perhaps nothing said as much about the transformation of political relations between the United States and Cuba that began in December 2014 as a concert in the Tribuna Antiimperialista.
Estimated portion of registered voters in Zimbabwe who are dead:
Zimbabwe Election Support Network (Harare)
Honeybees can recognize individual human faces.
Pope Francis announced that nuns could use social media, and a priest flew a hot-air balloon around the world.
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"Matt was happy enough to sustain himself on the detritus of a world he saw as careening toward self-destruction, and equally happy to scam a government he despised. 'I'm glad everyone's so wasteful,' he told me. 'It supports my lifestyle.'"


text:
- EMC CorporationInformation Storage Specialist, 2012 - presentInstructor for Latin America.
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- NBA Jam
- メタルスラッグ ディフェンス
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What parents need to know
Parents Need to Know
Parents need to know that Popplet is a mind-mapping tool that can be especially helpful for kids who have problems with organization and visual memory. The app allows kids to insert words, images, and their own drawings to help kids who benefit from visual presentation. It also has many uses, including classroom use for instruction and student projects. The terms of service prohibit kids younger than 13 from creating accounts, but the developer's policy does allow for parent/guardian or teacher-created accounts to be overseen by an adult and used by kids. Popplet allows collaboration and sharing of the creations, so objectionable content could get through.
What kids can learn
Language & Reading
- discussion
- presenting to others
- brainstorming
- combining knowledge
- making new creations
- presenting
Tech Skills
- digital creation
Engagement, Approach, Support
Popplets are fun to create, and kids will enjoy adding content to them and viewing them.
The app's design allows kids to easily make connections and delve deeper into ideas and concepts visually. The learning power of Popplets, though, is in the content. The simple delivery engages kids and helps them remember new information.
Online tutorials and examples make learning to create Popplets easy.
User reviews
Parents say
Kids say
What's it about?
POPPLET is a dynamic organization tool for users to create "Popplets" on a board. These Popplets can be filled with text, drawings, images, or video and then connected to other, related Popplets to create a mind map, similar to an interactive outline of related ideas. The Popplet board can be updated by multiple users in real time, so it's a collaborative tool for planning or discussion. Popplet boards can be shared, too.
Is it any good?
This productivity app has many uses, in business, personal planning and management, and education. It's fascinating and really easy to use. Kids may be drawn to the visual pop the Popplets have, especially when they add images and video and utilize the social aspects of sharing and collaborating in real time. However, the content kids create and share is wide-open -- so Popplet is technology, similar to texting and social media, that parents may want to keep a watchful eye on.
Families can talk about...
Talk to kids about appropriate uses for Popplets, outlining whether the tool should only be used for educational purposes and what is acceptable to create and share.
Show kids some of the organizational methods you used in school (outlines!) and talk about how technology and brain research have created new methods.
App details
|iPhone, iPod Touch, iPad
|Pricing structure:
|Free to Try, Paid
|Subscription price:
|Release date:
|October 22, 2012
|Minimum software requirements:
|iOS 5.0 or later
About Our Rating System
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