A National Clinical Trial Audit System to Improve Clinical Trials Reporting

The incomplete and inaccurate reporting of clinical trials is a well-documented research integrity problem. Major factors contributing to this problem are the failure of trial sponsors and principal investigators to prospectively register all trials, post the summary results of all trials, and publish the outcomes of all trials in academic journals. This has negative consequences for UK patients, UK taxpayers, and UK investors, which are also well documented. Successive UK governments have failed to monitor compliance with, or sanction the violation of, national and European Union regulations intended to partially resolve the issue. As a result, compliance is weak. The persistence of the problem more than two decades after it was first recognized shows that individual action by stakeholders and unmonitored and unenforced regulations are insufficient to resolve it. A national clinical trial audit system would substantially strengthen research integrity in this field by monitoring the registration, summary results posting and academic publication of every trial conducted in the UK, benefiting UK patients, UK taxpayers, and UK investors. A pilot has proven the feasibility of setting up such a system in the UK. The system would cost little to set up and run. Its work would be based on records that already exist, and thus it would not generate any red tape, costs, or time delays for institutions conducting clinical trials in the UK. There is broad support within the UK medical research community for a national clinical trial audit system. The system would provide Britain with a competitive advantage as a location for cutting edge clinical research and drug development.