An Oxford University initiative to spotlight the universities and pharmaceutical companies failing to report their trial results correctly has won the Cochrane-REWARD prize for reducing research waste.
The Trials Tracker Initiative is developed by the EBM DataLab team, led by Dr Ben Goldacre in the Nuffield Department of Primary Care Health Sciences. When trials go unreported the investment is spent, but the output is negligible. This has been the focus of a global campaign by the AllTrials group.
The TrialsTrackers are a range of tools that spotlight individual unreported trials, and give rankings for universities and companies. The full collection of all TrialsTrackers can be seen online at TrialsTracker.net.
In early 2018, the team launched the FDAAA.TrialsTracker.net, which monitors breaches of the FDA Amendments Act 2007, requiring certain trials to report results onto the register within 12 months of completion. The site implements this complex law in software, then flags individual unreported trials, with daily updates and rankings. As of 15 August 2018, just 59% of all trials required to report under FDAAA have submitted results to ClinicalTrials.gov since the new regulations came into effect in early 2017.
In September 2018 the team launched the EU.TrialsTracker.net, which covers all trials of medicines and vaccines in Europe since 2004. The site reports compliance with EU rules on trial reporting; the accompanying BMJ paper shows that drug companies are complying better than universities. Its launch was met with positive official statements from the European Medicines Agency themselves, and the Chair of the Parliamenary Science and Technology Select Committee.
The team also produce the regular Unreported Trial Of The Week series for the BMJ, spotlighting one unreported trial, and discussing the clinical impact, alongside additional interesting issues around trial reporting regulations.
Their work has already begun to have positive impact, with staff from individual universities getting in touch to say that they have used the data provided by the trackers to identify unreported trials in their institution, and get them reported.
An estimated $170 billion of research finding is wasted each year because its outcomes cannot be used. Much of this waste appears to be avoidable or remediable. The Cochrane-REWARD prize aims to stimulate research in this area.
This year’s prize of £2500 was also awarded to the UK Equator Centre for the Good Reports Tool and the James Lindt Alliance for their Priority Setting Partnerships, which shared the joint second prize with the EBM DataLab.