Increasing the trial process evidence base without increasing research waste
Brighton, UK

Speaker: Shaun Treweek

This is a talk at the International Clinical Trials Methodology Conference (ICTMC), Brighton, UK, 6th – 9th October 2019.  Venue is the Hilton Brighton Metropole.


Parallel Session 7C – Reducing Research Waste
Tuesday, Oct 8, 2019
2:00 PM – 3:05 PM


The evidence available to inform trial process decisions is thin. This leads to research waste.  One way of improving the evidence base is to evaluate trial process alternatives in a Study Within A Trial (SWAT).  SWATs are gaining traction, especially in the UK and Ireland, with SWAT funding streams from the National Institute for Health Research (NIHR) and the Health Research Board (HRB) in Ireland.

The problem ahead

NIHR, HRB and others see a problem ahead: how do we avoid contributing to research waste ourselves by funding or doing SWATs that have, in fact, already answered their questions?  

Developing criteria to make sensible judgements

Trial Forge brought together a group of 28 trialists, methodologists, clinicians, patients, research funders and research governance staff from the UK, Ireland and Switzerland to develop a set of criteria to make decisions about when doing another evaluation of a SWAT is needed. 

I will present our five criteria.  The criteria consider the evidence coming from the cumulative meta-analysis of all evaluations of the SWAT, the certainty we have in that evidence judged using GRADE, the contexts in which the SWAT has been evaluated, and the balance of benefit and disadvantages for a) participants and b) the host clinical trial.  I will present worked examples of how the criteria apply to two SWATs, one in recruitment, one in retention.  I will also discuss how these criteria can be used to not only make decisions about whether a SWAT needs further evaluation but to guide the selection of the types of trials in which to embed future SWAT evaluation.  


To avoid research waste, decisions about which SWATs to evaluate, how and where needs a coordinated and structured approach.  The criteria we have developed are the start of such an approach.  

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