Randomised trials, especially when brought together in systematic reviews, are regarded as the gold standard for evaluating the effects of healthcare treatments with thousands of trials and hundreds of systematic reviews reported every year. PubMed has indexed over 370,000 reports of randomised trials; the World Health Organisation’s International Clinical Trials Registry Platform contains over 250,000 trial records, of which 71,000 are listed as recruiting; and the Cochrane Central Register of Controlled Trials contains more than 800,000 records. Tens of billions of dollars of public and private money are invested globally in trials every year (US$25 billion in the US alone in 20103) and the average cost of recruiting a patient to a trial in the UK is estimated to be almost £8,500.
Much of these resources is wasted, often because results are not published, or are poorly reported. However, resources are also wasted because the research asks the wrong questions or is badly designed. Moreover, despite trials being a cornerstone of evidence-based healthcare, the methodology and infrastructure for conducting these complex studies is a largely evidence-free zone.
The Trial Forge initiative aims to make trials more efficient by looking for small gains across all trial processes, from research question through to reporting. 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. Where no evidence exists (as will often be the case), Trial Forge will provide a platform to highlight this gap and bring researchers and others (including funders) together so that they can fill the gap. Insights from disciplines not normally associated with trials, such as business and organisational change management, will be part of this efficiency drive.
Trial Forge is led by Shaun Treweek at the University of Aberdeen. Daniel Shanahan of Biomed has written a blog on the first Trial Forge workshop, which is available at http://blogs.biomedcentral.com/bmcblog/2014/07/15/wheres-the-evidence-for-how-we-run-clinical-trials/. Further details on Trial Forge are available at http://www.trialforge.org.
Shaun Treweek; email@example.com
Data collection ongoing