The UK’s House of Commons Science and Technology Select Committee has published its report on Clinical Trials today. The Committee described the current lack of transparency of many clinical trials as “unacceptable”, adding that it has not been impressed with Government efforts to tackle the problem to date. The report supports the AllTrials campaign’s calls for universal trial registration and summary results reporting and for clinical study reports, where they have been produced, to be shared.
The report makes some good recommendations:
- That all trials conducted on NHS treatments—and all other trials receiving public funding—should be prospectively registered and their results published (Measures are already in place to make this happen – the Health Research Authority will make prospective registration a condition of ethical approval for a trial at the end of this month).
- That the Government conducts a retrospective audit of publicly funded trials since 2000 to assess how many were not registered and had not reported results, and support the retrospective registration of trials with resources for researchers.
- The Committee called on the Government to take its recommendations into account in ongoing discussions regarding the revision of European clinical trials legislation and in its response to the European Medicines Agency’s consultation on the release of clinical trial data, which closes at the end of this month.
The Committee does recommend that all trial results are published in a peer reviewed journal. We think this recommendation is directed to the wrong place. Trial results should be publicly available and ideally published to the publicly accessible register the trial was registered on.
Ben Goldacre, doctor, author of Bad Pharma and co-founder of AllTrials: “We need to ensure that doctors and patients have access to all results of all trials that have ever been conducted on all treatments in current use, in order to make informed decisions. Most of the medicines doctors prescribe today are based on data from clinical trials from a decade or more ago. Over the next two years, many of the drugs in common use will come to the end of their patent life. When that happens, it may become even harder to get the information that has been withheld so the Committees recommendations on auditing and registering past trials are very welcome.”
Síle Lane, Sense about Science, one of the co-founders of AllTrials: “We are clearly pleased that the Committee supports our call for all clinical trials to be registered and results reported, and glad that the Committee is urging the Government to take their recommendations into account in the Government’s response to ongoing discussions in Europe. We need strong support for these recommendations in Europe and for bodies worldwide to take action.”
Carl Heneghan, Will the goverment take action on clinical trials?
The Guardian, Why the data on all drug trials must be released
PharmaTimes, Commons Committee wants more action on transparency
The Institute of Cancer Research, Statement in response to Commons Committee report