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April 12, 2012

Clinical Data Transparency Considered by Group of European Regulators

by Howard E. Rosenberg, Ph.D.

people-in-line.jpg Doshi et. al. ("Doshi") in a recent publication in PLoS Medicine highlighted their difficulties in obtaining full clinical trial data surrounding the approval of the influenza antiviral Tamiflu® (oseltamivir). Their interest in the drug was aroused when they began examining claims for the utility of drug and the differing ways that the World Health Organization ("WHO"), FDA and other health authorities around the globe interpreted the effectiveness and thus the recommended method of treatment plans for the drug. The information that was freely available to Doshi came from published trial data and meta-analyses but this proved to be unsatisfactory, as it did not allow them to really examine how the differing understandings of the drug's effectiveness and treatment patterns were decided upon by the world health authorities.

Widening their research into clinical trial reports and published data provided for other drugs that had subsequently been withdrawn or turned out to be unsatisfactory (e.g., rosiglitazone, rofecoxib, etc.), when it became clear to them that what they needed to see original clinical trial data without any "spin" attached. They pointed out that although published randomized clinical trials ("RCTs") are considered the "gold standard" source of synthesized evidence, their conclusions are vulnerable to distortion when the trial sponsors have strong interests that might benefit from suppressing or promoting selected data. From their point of view, a better method to independently assess drugs would be to enable the access and review of the clinical trial documentation and reports sent to the government drug regulators. However, these reports are historically treated as commercial confidential documents, impeding additional scrutiny by independent researchers. As a result, Doshi was unable to get all the data they required for their Tamiflu® project, despite putting in a great effort trying to get key documents released by government regulators.

A group of European regulators have replied to the Doshi article, agreeing that clinical trial data should not be considered commercial confidential information, particularly as most patients enrolling in clinical trials do so with an assumption of contributing to general medical knowledge, and that non-disclosure of complete trial results undermines this. They see many potential advantages in having public disclosure, for example, in enabling the development of predictive models for patient selection to appropriate treatments and the potential for better individualized therapeutic decisions.

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April 23, 2010

Financial Interest and Transparency - Advisory Committee Information and Waivers

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On April 21, FDA announced draft guidance for public availability of advisory committee members' financial interest information and waivers. FDA is advised by almost 50 committees with more than 600 members that provide advice--but do not make decisions--on specific regulatory topics or proposed product approvals. Some meetings have the need for special members with expertise that may have financial conflicts of interest. By law, FDA can grant waivers for such conflicts for about 13% of advisory committee members but reportedly only grants waivers for less than 5% of the members.

The guidance differs from previous agency procedures by not only disclosing that a waiver was granted for a financial interest but also providing the name of the company or institution associated with the financial interest and posting this information on the Internet at least 15 days prior to committee meetings (or as soon as practical if FDA is aware of the information less than 30 days prior to the meeting). FDA must broadly provide FDA's rationale for the waiver--(i) the financial interest is not substantial enough to affect the member's integrity, (ii) the need for the member outweighs the potential for conflict, or (iii) the member's service is necessary to provide the committee essential expertise. The guidance also places would-be advisory committee members on notice the type and extent of information that will be provided to the public.

In mid 2009, FDA held a meeting to solicit comments for ways to increase FDA transparency and currently has a task force making recommendations, posting transparency blogs, and held three additional industry listening sessions in March 2010. FDA has an ongoing task force looking for ways to provide additional information to the public, while protecting confidential information as needed.