In 2012 British Cycling’s performance director Dave Brailsford put Team GB’s dominance at the Olympics down to marginal gains – the idea that if you break down everything you could think of that goes into riding a bike, and then improved it by 1%, you will get a big gain when you put them all together. Trial Forge aims to do the same for trials.
A paper in Trials describing the Trial Forge approach is available at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0776-0.
Once a trial process has been identified (e.g. recruitment, retention), the next part of the Trial Forge process is to collate what we already know about that process. This is important because we don’t want to reinvent the wheel, or fail to learn what we can from existing work. To do this we’ve developed an idea called TRINITY packages. As the name suggests, these comprise three systematic reviews on the chosen process. The first summarises factors that affect the process (the Factors review). The other two reviews look at evaluations of initiatives designed to improve the process, the first covering randomised evaluations (the Randomised evaluations review), the second non-randomised evaluations (the Non-randomised evaluations review).
These reviews feed into each other. The Factors review will suggest targets for interventions and initiatives, problems that we should be aiming to reduce, or enabling factors that we should try to embrace. In other words, as well as summarising what we know, the review will suggest the things we ought to be evaluating in randomised or non-randomised evaluations. The two evaluation reviews will tell us which interventions are worth using, which need more work and which we should stop using. Both evaluation reviews could suggest that an intervention ought to be evaluated in a different way, perhaps moving the evaluation to the other review. This is particularly likely if we have promising non-randomised evaluations: the review could suggest that in future the intervention should be tested in a randomised evaluation.
The first TRINITY package is looking at recruitment and involves, among others, Heidi Gardner, Katie Gillies and Shaun Treweek in Aberdeen (see below) and Catherine Houghton and Declan Devane in Galway.
Trial Forge is coordinated from the Health Services Research Unit at the University of Aberdeen (http://www.abdn.ac.uk/hsru/) by:
Adel El Feky, who is doing a PhD called ‘What is the best way to avoid recruitment and retention problems in trials?‘ Adel’s profile is at http://www.abdn.ac.uk/hsru/people/r01age17/
Heidi Gardner, who is doing a PhD called ‘Making clinical trials more efficient: consolidating, communicating and improving knowledge of participant recruitment interventions‘. Heidi’s profile is at http://www.abdn.ac.uk/hsru/people/r01hg15/
Katie Gillies, who is doing an MRC Methodology Fellowship called ‘Evidence-informed decision aids for clinical trial participation: a methodological investigation of core components and outcome measures‘. Katie’s profile is at http://www.abdn.ac.uk/hsru/people/k.gillies/
Shaun Treweek, who is leading Trial Forge and doing some other trial-related stuff, especially related to trial recruitment. Shaun’s profile is at http://www.abdn.ac.uk/hsru/people/s.treweek/.