Regulatory Focus™ > News Articles > Group Calls on Regulatory Agencies to Release Clinical Trials Data

Group Calls on Regulatory Agencies to Release Clinical Trials Data

Posted 09 January 2013 | By

A new initiative started by a group of research groups, including the British Medical Journal (BMJ), the Cochrane Library and host of other influential researchers, is calling on regulators to require that the results of all clinical trials information be published.

The group, calling themselves "All Trials Registered, All Result Reported Initiative," notes in a statement that, "Thousands of clinical trials have not reported their results; some have not even been registered [with regulators].

They continue: "Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated unnecessarily on people and animals. All trials past and present should be registered, and the full methods and the results reported. We call on governments, regulators and research bodies to implement measures to achieve this."

A Transparency Initiative Long in the Making

The call for transparency is hardly new. Groups have for years been urging governments across the globe to require that any company or entity conducting a clinical trial commit to publishing the full results of the study. At present, some companies refuse to publish the data, citing patient confidentiality or competitive concerns. Others cite the potential for patients to misread data from potentially flawed or incomplete studies.

Some companies and regulators have heeded the call, however. Pharmaceutical manufacturing giant GlaxoSmithKline announced in October 2012 that it would meet researchers halfway, allowing selected persons access to anonymized trials data for any product.

"As a truly global healthcare company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges," said Sir Andrew Witty, CEO of GSK, at the time of the company's announcement.

EU officials have meanwhile released a draft rewrite of the EU Clinical Trials Directive, which would require companies to submit some-but not all-trials results to an EU database likely maintained by the European Medicines Agency (EMA).

Critics Call Other Efforts "Weak"

But critics, including those behind the All Trials initiative, say those reforms are "extremely weak," and have instead pressed for "all" information to be released. On average, about half of all trials are never published, they said, and missing data has left prescribing physicians without the ability to determine what is best for their patients.

"All involved parties need to work to ensure that all results of all clinical trials-past and future-on all treatments in current use are available to doctors and patients,so that they can make informed decisions about treatments," the group wrote in a research piece posted on its website.

Significantly, the group also raised the prospect of calling for journals to boycott the publication of any study that does not make available data upon request. Some, such as the British Medical Journal, one of the All Trials Initiative's sponsoring organizations, have already done so.

It is unclear whether the initiative would press for all trials data to be released for trials on rare disease patient groups, which because of the small size of the patient population may be more easily identifiable as the result of information in the trial results.

As of the time of this article's publication on 9 January 2013, the group's petition to regulators and governments to enact trial transparency measures has just shy of 3,000 signatures.


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