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Government must take action to tackle lack of clinical trial transparency, say MPs

17 September 2013 The Science and Technology Committee has 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.

  • Report: Clinical trials (HTML)
  • Report: Clinical trials (PDF)
  • Inquiry: Clinical trials
  • Science and Technology

Committee Committee Chair Andrew Miller MP said:

“Many of the trials taking place today are unregistered and unpublished, meaning that the information that they generate remains invisible to both the scientific community and the public. This is unacceptable, undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk. We consider that all trials conducted on NHS treatments—and all other trials receiving public funding—should be prospectively registered and their results published in a scientific journal. While the focus should be on implementing this change for future trials, the Government must also do what it can to ensure that historic trials are registered and published, particularly where they have been publically funded.” The Committee also asked the Government to take steps to facilitate greater sharing of the raw data generated during a trial. Andrew Miller explained:

“We are not in favour of the uncontrolled release of potentially sensitive patient data, even in anonymised form. However, raw trial data is currently underutilised and could be of significant scientific value if shared in a responsible and controlled way, with the knowledge and consent of patients.”The Report also drew attention to the recent fall in the number of trials taking place in the UK, stating that the UK was a “particularly challenging” place in which to conduct a trial. It found that the need for multiple governance approvals from participating NHS organisations remained the biggest barrier to setting up a UK trial, but that lack of public awareness was also a key issue.

Andrew Miller stated:

“Clinical trials make a significant contribution to the UK economy and can provide patients with an important means of accessing the most exciting new treatments.Unfortunately, the UK governance landscape means that researchers can struggle to get trials up and running in this country. Recruiting participants can also be a challenge, even though many patients welcome the opportunity to take part in a trial. These problems are not insurmountable and we are confident that the Government is aware of the need to resolve them. But it is now time for the Government to translate its words into effective action.”

The Report 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.

MPs call on Government to ensure clinical trials are registered and reported

17th September 2013 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. Read the report and the evidence sent into the enquiry (PDF) from many of the organisations and supporters of AllTrials.

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.”

  • The Guardian, Unfavourable results from medical trials are being withheld, MPs warn
  • Carl Heneghan, Will the goverment take action on clinical trials?
  • BMJ, MPs condemn UK clinical trials system for its “invisible” results
  • The Guardian, Why the data on all drug trials must be released
  • PharmaTimes, Commons Committee wants more action on transparency
  • PMLive, UK Government ‘must push for clinical trial transparency’
  • Simon Denegri, Do I detect a slight fumble of the ball in today’s Commons Select Committee report on clinical trials?
  • The Institute of Cancer Research, Statement in response to Commons Committee report

HRA, Response to House of Commons Science and Technology Committee report into Clinical Trials – See more at: http://www.alltrials.net/2013/mps-call-on-government-to-ensure-clinical-trialsare-registered-and-reported/#sthash.a9Ifjh6O.dpuf

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