Tuesday, September 17, 2013

MPs condemn UK clinical trials system for its “invisible” results - BMJ

By Adrian O’Dowd

The committee’s chairman, Andrew Miller, the Labour MP for Ellesmere Port and Neston, said, “Many of the trials taking place today are unregistered and unpublished, meaning that the information that they generate remains invisible to both the scientific community and the public.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.”

The MPs said they believed that it should be a contractual requirement for all trials conducted on NHS treatments—and all other trials receiving public funding—to be prospectively registered and their results published in a scientific journal.

Although the immediate focus should be on change for future trials, the government should also do what it could to ensure that historical trials were also registered and published, they added.

The committee also called on the government to take steps to make it easier for the raw data generated during a trial to be shared more widely.

Miller said, “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 says, “We recognise the efforts of some members of the pharmaceutical industry, particularly GSK, to increase clinical trial transparency and hope that other companies will act in the same spirit in implementing industry-wide principles for responsible clinical trial data sharing.”

During the committee’s inquiry the BMJ’s editor in chief, Fiona Godlee, had given evidence criticising researchers who kept trial results “in their bottom drawer” if they did not “come up with the results that they wish[ed] for.”2

Godlee acknowledged that journals in the past had been at fault for failing to publish negative results but claimed that the introduction of open access journals and online journals with more space meant that this was no longer the case.

The report also highlights the issue of a recent fall in the number of trials taking place in the UK and says that the need for many governance approvals from participating NHS organisations remains the biggest barrier to setting up a UK trial. Lack of public awareness was also a key issue, it said.

The committee asked the government to take its recommendations into account in ongoing discussions on 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.

Cite this as: BMJ 2013;347:f5641

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