Using Studies Within a Trial (SWATs) to increase the evidence base for trial process decision-making
New Orleans, USA

Speaker: Shaun Treweek, Andrew Cook, Katie Gillies, Spencer Hey, Jan Jansen, Adwoa Parker

This is an evening workshop held as part of the Society of Clinical Trials 2019 conference (see

Workshop: 7pm – 9pm at the Sheraton Hotel, Canal St, New Orleans

Useful background: SWAT Guidance 1 (

Randomised trials are at the heart of clinical guidelines affecting the care of millions of people around the world and are central to evidence-based health care systems.  It is odd then that the evidence available to trial teams to inform their own decisions about trial design, conduct and dissemination is so sparse. This is true for trial processes from choice of research question through dissemination of results.

To give some examples, around half (at least) of trials fail to recruit to target and those that do often fail to keep participants in the trial, with half of trials losing more than 10% of their participants before the primary outcome is measured.  Despite more than 25,000 trials a year being reported, all of which must recruit and retain participants, the evidence base to support evidence-informed recruitment and retention strategies is thin.  If we move to trial management decisions (e.g. how to best train site staff, how to monitor sites) we will find practically no evidence to support those decisions.  Data management, an activity that is estimated to account for 30% of all trial work, does not have a substantial evidence base on which to base decisions about, say, choice of data collection method, or the degree of error checking that is appropriate given the nature of the trial.

This interactive workshop will give an overview of the trial process evidence problem and also introduce a key tool in the methods evaluation armoury– the Study Within A Trial (SWAT).  We will explain the need for coordinated and collaborative work so that trustworthy evidence is generated in a few years not decades as is currently the case.  We will consider what the opportunities, challenges, barriers and enablers are to routinely evaluating trial process interventions in ongoing trials, including interventions that are widely used but have little or no evidence of benefit to support their use.  We will provide funder, clinician and ethicist perspectives.

This workshop will give participants a chance to expand their understanding regarding gaps in trial process evidence and the harm this does, understand the importance of coordination and collaboration to meaningful improvements in the evidence base, as well as explore their own ideas regarding priorities for methodology research to support trial process decision-making.  We hope that many participants will develop their own SWATs and perhaps collaborate in with us in these future evaluations.

The structure of the workshop will be as follows:

  1. Introduction and learning a bit about participants and what they want from the workshop (Shaun Treweek, 5 mins)
  2. The trial process evidence problem and the harm it leads to (Shaun Treweek & Katie Gillies, 10 mins).
  3. A tool to increase the evidence base: the Study Within A Trial (SWAT) (Adwoa Parker, 10 mins).
  4. Why would a trial funder be interested in SWATs? (Andrew Cook, 8 mins)
  5. Why would a clinician be interested in SWATs? (Jan Jansen, 8 mins)
  6. Small group work. We will divide participants into small groups of around 4-8 people.  We will give participants two SWAT examples, which they can use as the focus for answering the following questions (30 mins):
    1. What are the challenges I would face if I wanted to embed these SWATs in my trials?
    2. What would reduce these challenges?
    3. What would convince your colleagues that SWATs were worth doing?
    4. What would need to be done to make doing SWATs mainstream in your field?.
  7. Feedback from each group – A representative of each group will give feedback on the group’s discussions and other groups will be invited to comment (20 mins).
  8. SWATs– an ethical perspective from the US (Spencer Hey, 10 mins)
  9. Open discussion, questions from participants and summing up (approx 20 mins).

Target audience
Anyone interested in improving the evidence base for trial process decision-making.

Goals of the session
For delegates to a) gain an overview of the harm the lack of trial process evidence does b) learn about SWATs as a way of increasing the evidence for trial process decisions c) have a hands-on session to discuss issues around evaluating SWATs in participants’ own fields and institutions.

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