Improving the evidence base for trial process decision-making: Studies Within A Trial (SWAT) and why we should be coordinating and doing more of them
Portland, USA

Speaker: Shaun Treweek

This is an oral presentation at the Society of Clinical Trials annual meeting, to be held 20th – 23rd May (date to be confirmed) at the Hilton Portland & Executive Tower. 921 SW Sixth Avenue, Portland, Oregon 97204, USA.

This talk will introduce SWATs, explain why they are important and how to design them as well as providing some practical ‘top tips’ from the experience of doing SWAT in the UK and Ireland.

Experience shows that SWATs need not be expensive, are ethically acceptable (in the UK and Ireland some types have not needed formal approval by an Ethics Committee) and analysis is often simple.  There are challenges though, which will be discussed.  They work best when done as part of a coordinated and collaborative initiative to reduce uncertainty around high priority trial process alternatives.

Two concrete examples of collaborative SWATs will be presented, including one evaluating the effect on recruitment of a structured way of developing participant information materials.  This was tested in four trials in three years, involved nearly 8000 people and gave a clear result: little or no effect on recruitment (absolute increase = 1% (95% CI = -1% to 2%); GRADE assessment: high certainty).  The recent update of the Cochrane systematic review of interventions to improve recruitment (which ST leads) finds that the global literature supports this level of certainty for just two other interventions.  The evidence behind the other 69 interventions in that review is far less certain and, even for the two other high certainty interventions, little has changed since 2004.

A SWAT protocol together with coordinated, collaborative evaluation can take evidence from a standing start to evidence-informed decision making in a few years. The current approach to finding ways to improve trial processes takes decades.



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