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Education section – Studies Within A Trial (SWAT)

In earlier issues of the Journal of Evidence Based Medicine, we have discussed the importance of randomised trials for resolving uncertainty about healthcare interventions and actions; but what about uncertainty in the methods for doing these trials? How should one identify and resolve that uncertainty, given that there are alternative approaches to many of the steps in doing a trial? This article discusses the SWAT programme, established by the All-Ireland Hub for Trials Methodology Research in collaboration with the MRC Network of Hubs in the UK and others, to help tackle this through the conduct of research within research. SWAT means Study Within A Trial. There have been hundreds of thousands of clinical trials in the last few decades that have recruited tens of millions of patients; and at least 25,000 trials are likely to be ongoing at the moment across the world [1], and yet the amount of research into the conduct of trials is negligible. For example, the recent update of a systematic review of research to improve recruitment to randomized trials found only 45 eligible studies which contained a total of less than 45,000 participants [2]. Similarly, there are relatively few systematic reviews of research into the methodology of trials [3], although this is increasing in part through the work of the Cochrane Methodology Review Group and others working in and alongside Cochrane Methods Groups. The SWAT programme is identifying issues about the methods of trials about which there is sufficient uncertainty to justify a research study to help resolve this uncertainty and generate the evidence needed to support well-informed decision making about future designs and choices. It will build an online library for these methodology studies and a data repository into which people using the designs could log their study prospectively and deposit their findings to contribute to meta-analyses of the individual SWAT. This major collaborative effort would include mechanisms to allow people to propose new topics for SWAT, submit new designs and suggest modifications to existing ones, and report problems in implementing them. Some of the topics that are already underway or are being prepared as SWAT are outlined below. One of the challenges that many multi-centre trials encounter is that recruitment slows in one or more centres. A potential solution to this is for the principal investigator or the core team to visit the site that is struggling. This SWAT would explore the impact of such visits on recruitment, while also analyzing whether the boost in recruitment that might follow such visits is simply an example of regression to the mean (when a site that was doing poorly picks up again as part of a natural cycle), and whether the patients that are recruited in such a boost go on to complete the trial. There is debate about whether making data from trials available to other researchers or to people in general through, for example, the internet will improve the quality and transparency of research or hinder research through the need to remove key elements of patient characteristics from the anonymised dataset. It is also uncertain if patients will be more or less likely to take part in trials if their data will be made available in this way. The impact of proposing different levels of access to data by people outside the original research team could be explored in the context of real trials or through the use of a variety of information leaflets that could be shown to people who would be asked to comment on the potential of the different approaches to influence their willingness to take part in research. Social media (including Facebook, LinkedIn and Twitter) are being used to promote research and to encourage participation and collaborative working. A SWAT could investigate the advantages and disadvantages of using these new tools for recruitment, retention and adherence in randomized trials. Finally, in this short list of examples, SWATs could be done to explore the understanding that potential participants have of the randomization process. This might include tests to determine any differences that arise if the random allocation is done by the participant (for example, by having her choose the sealed envelope that contains the details of the intervention to use) or by the researcher in the presence (or not) of the participant. This section was prepared as part of the work of the All-Ireland Hub for Trials Methodology Research and the TENALEA project. The TENALEA project provides an online system for the registration and randomisation of participants into research studies in health care. It has been developed by the National Cancer Institute in Amsterdam in The Netherlands, working with partners in some of the largest cancer research groups in Europe and is now being deployed, with funding from the European Union (contract C029334). More information, including details of how to use the system, is available at www.tenalea.com. Further information on the All-Ireland Hub for Trials Methodology Research and the MRC Network of Hubs is available from. http://www.qub.ac.uk/research-centres/ CentreforPublicHealth/Research/TheAllIrelandHubforTrialsMethodologyResearch/.