How do we know if a site is performing well? We are all interested in trial site performance. Julie Turzanski, Diane Whitham and Leila Duley at the Nottingham Clinical Trials Unit are leading a [...]
Randomised controlled trials are the gold standard for evaluating healthcare treatments; 1000s are done every year.
Randomised trials are the cornerstone of evidence-based healthcare because they offer the fairest tests of treatments, therapies and initiatives.
The evidence base for how to make the trials process efficient is remarkably thin. Trial Forge aims to change this.
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. The British Cycling results from the 2016 Rio Olympics show how successful this technique is. Trial Forge aims to do the same for trials.
Trial Forge will make trials more efficient by looking for marginal gains across all trial processes, from research question to implementation into routine care. It will encourage everyone connected with trials to be more sceptical of what we do by asking for the evidence behind all of our trial decisions.
In the context of clinical trials, ‘‘quality’’ can be generally defined as the absence of errors that matter to decision-making—that is, errors which have a meaningful impact on the safety of trial participants or the credibility of the results (and thereby the care of future patients). (Clinical Trials. 2016 Apr 20.)
While the research questions and ideas can be novel and ambitious, some of the more challenging questions can often be found in teasing out the methodological issues that surround a clinical trial.
There is a peculiar paradox that exists in trial execution - we perform clinical trials to generate evidence to improve patient outcomes; however, we conduct clinical trials like anecdotal medicine. (Heart Fail Review 2012; 19: 135-52)