Excellent to see the UK House Of Commons Health Select Committee making such a clear statement about the ongoing problem of missing trial results, which the ABPI have laughably claimed is “historic“.
They call upon NICE, the GMC and the pharmaceutical industry to address the problem, and they also take a very strong clear position: that withholding the results of clinical trials should be neither legal nor ethical.
Do please sign up to the alltrials.net campaign, calling for publication of all Clinical Study Reports, for all trials, on all treatments currently in use.
And also consider responding to the House of Commons Science and Technology Select Committee report on withheld trial results, closing next month.
Access to clinical trials data
The MPs also express concern about the implications for the effectiveness of NICE of recent evidence about access to information from clinical drug trials. They argue that there should be both a professional and legal obligation to ensure that all regulators, including NICE, have access to all available research data about the efficacy and safety of pharmaceutical products which are in use in the UK. All information arising from drug trials concerning drugs that are in clinical use should be in the public domain in an accessible form. The Committee urges the pharmaceutical industry to introduce a new code of practice to make this commitment effective and calls on the GMC to reiterate its guidance to doctors on the conduct of drug trials.
The Committee argues that it should be neither legal nor ethical to withhold research data about pharmaceutical products which are in clinical use. It is concerned that the fact that this simple principle is not universally applied in practice undermines the effectiveness of NICE; the Committee welcomes the current review of these issues by the House of Commons Science and Technology Committee and recommends that that Committee should examine the nature of both the legal and ethical principles which should cover these issues and how to make those principles enforceable in practice.