Posted on Friday 27 September 2013

Well a blog isn’t actually a news channel, but I’ll give it a shot. The UK Science and Technology Committee of the House of Commons has issued quite a report. Here are three excerpts below of the news coming out of the UK: an article from PharmaTimes; links to the full report from that committee with the pertinent part of the summary; and a section of Iain Chalmers’ comments in the BMJ. It’s really quite a positive recommendation, and there’s more good news on the AllTrials web site. While the US Congress is trying to decide if we can even have a government or not, the UK Parliament appears to be on a real roll:
Pharma Times
by Peter Mansell
September 17, 2013

It is “unacceptable” that many clinical trials remain unregistered and unpublished. Moreover, “we have not been impressed by the Government’s efforts to resolve this problem to date”, a House of Commons committee has concluded. The current lack of transparency around clinical trials is undermining public trust, slowing the pace of medical progress and potentially putting patients at risk, says the House of Commons Science and Technology Committee in a wider report on the environment for clinical studies in the UK and the European Union.

The report is based on an inquiry launched in December 2012, which addressed issues such as transparency and disclosure of clinical-trial data; barriers to conducting trials in the UK and EU; the European Commission’s proposed revisions to the Clinical Trials Directive; and the role of the UK’s Health Research Authority in relation to clinical trials.

Registered, published
The Committee would like to see all trials conducted on treatments used in the National Health Service prospectively registered and the 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 publicly funded,” added Committee chair Andrew Miller MP.

The Committee also asks for government action to facilitate wider sharing of the raw data generated during clinical trials. It does not favour the uncontrolled release of “potentially sensitive” patient-level data, even in anonymised form. However, raw trial data are “currently underutilised and could be of significant scientific value if shared in a responsible and controlled way, with the knowledge and consent of patients”, Miller commented

    … Another key focus of our inquiry has been the issue of clinical trial transparency. We consider that information relating to trials should be shared in a way that is accessible, assessable, intelligible and usable, and we have differentiated in our recommendations between four distinct levels of trial transparency:
    [a] Universal trial registration is crucial to increasing transparency and, in future, all clinical trials conducted in the UK, and all trials related to treatments used by the NHS, should be registered. We extend this recommendation to past trials, and urge the Government to support the retrospective registration of all trials conducted on treatments currently in use by the NHS.
    [b] It is also important that summary-level trial results are made public, and we do not accept the argument that it is not possible to publish “negative” results in peer- reviewed scientific journals. We recommend that trial registration and publication of summary-level results be made contractual requirements for all publicly-funded trials, including those covered by the Charity Research Support Fund, and urge the Government to conduct a retrospective audit of all large public trial grants awarded for Clinical trials since 2000 to ensure that they have been registered and published.
    [c] It would be unduly burdensome to mandate that full trial reports— clinical study reports [CSRs]—be produced for non-commercial trials. However, in cases where they are already produced for regulatory reasons, CSRs can make a useful contribution to the scientific literature. Once a regulatory decision has been reached, there is no compelling reason why CSRs should not be placed in the public domain, with identifiable patient data redacted.
    [d] We are not in favour of placing anonymised individual patient-level data [IPD] in the public domain in an unrestricted manner, as the risk to patient confidentiality is too great. Instead, specific individuals should be provided with controlled access to IPD through carefully managed and secure “safe havens”. Access should be facilitated by an independent “gatekeeper”, responsible for ensuring that data is handled responsibly and in a way that makes a useful contribution to scientific knowledge. We consider the current lack of trial transparency to be unacceptable and we have not been impressed by the Government’s efforts to resolve this problem to date. We ask the Government to enhance its efforts to increase transparency and to consider the recommendations of this Report in preparing its response to the European Medicines Agency’s ongoing consultation on access to clinical trial data.

British Medical Journal
by Iain Chalmers
September 25, 2013
[posted in full at PharmaGossip]

…In the UK, universal trial registration could have been introduced years ago had the national oversight of research ethics committees been blessed with the quality of leadership that it now has. In just over a year since her installation as chief executive of the Health Research Authority, Janet Wisely has achieved the political and professional consensus to enable her to announce that, from 30 September 2013, trial registration will be required as a condition for ethical approval. Without the uncertain and drawn out process of trying to introduce legislation to require trial registration, the authority has put in place the first step needed to monitor and deal with under-reporting of clinical research in this country.

Now that the authority has established the basis for complete registration of UK trials, it should be tasked to ensure that trialists’ use of its integrated research application system  automatically generates a trial registration entry, and that the resulting records are used to create a UK clinical trials register. This register would not only allow UK specific monitoring of trial publication but would also meet the criteria for inclusion in the international clinical trials registry platform. Searches using this platform would then cover all UK trials and those registered in national registers in Australia, Brazil, China, Cuba, Germany, India, Iran, Japan, Korea, the Netherlands, New Zealand, and Sri Lanka, as well as those in the ISRCTN register, ClinicalTrials.gov, the European Union register, and the Pan-African registry .

The Health Research Authority could develop the integrated research application system to reduce the bureaucracy of trial registration for UK based trialists. The authority could also ensure that trial protocols become available routinely at the time of registration, and that user friendly information about currently recruiting trials is provided for potential trial participants.
While they didn’t go so far as supporting unrestricted access to anonymized subject data, they even made a provision for access under supervision. Their recommendations were a sweeping endorsement for putting an end to data secrecy. I have to say that I’m an optimist by nature, but when AllTrials was launched in January, if you’d asked me if it would get this kind of endorsement by September, I would’ve thought you very naive. I’m delighted to be wrong about that. The report says:
116. We are supportive of the broad aims of the AllTrials campaign and agree that all clinical trials should be registered and their results reported. We suggest that the AllTrials campaign clearly set out what it considers a full trial report to contain, particularly when prepared for non-commercial purposes, so that its supporters can work together to achieve a specific set of common goals.
I know it’s hardly a done deal, but this is big progress, and the AllTrials leaders deserve nothing but praise for their efforts [and their success]…

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