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Compliance In Focus
Posted by Sandra Maddock on Tue, Oct 16, 2012

Where is EMA Falling Short? See Audit Results!

Conflict of interest can be defined as occurring when an individual or organization is involved inCOI multiple interests, one of which could possibly corrupt the motivation for an act in the other.  While many may see disclosure of conflict of interest as just another form to check off the list, it’s an important aspect in a study to ensure the trial is conducted with the utmost integrity and responsibility.

Per the regulations, most clinical trials require disclosure of conflict of interest (COI). This is required by the investigator(s) to the sponsor, then from the sponsor to the FDA. The FDA then considers whether adequate steps are taken in the design, conduct, reporting and analysis of studies to minimize bias. However; the idea of conflict of interest should extend further then just in clinical trials. What about if there is a conflict of interest between those reviewing research? What happens if there was an unseen influence on their decision?

It seems this is something EMA is falling short to adequately address. According to recent reports, auditors have discovered that EMA “despite its attempts to increase transparency and implement conflict-of-interest (COI) policies, is falling short of its responsibilities to, adequately manage COI situations. This audit was performed by the European Court of Auditors (ECA) and had a few recommendations for the agency, including:

  • Screening candidates for conflict of interest before their appointment;
  • Establishing conflict of interest policies and procedures which would ensure that conflict of interest situations are managed to a comparable standard by national authorities performing outsourced tasks;

It wasn’t too long ago that FDA released a guidance called, “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.” This guidance also touched on 21 CFR 54; Financial disclosure, which can be a source of bias for the outcome of a study.  While the guidance released is specific to advisory committees, its goal is to help provide clarity to the FDA processes, and standardize of public disclosure of the COI information.

Do you think EMA could benefit from more transparency like the FDA? Do you agree with the recommendations? Let us know what you think.

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Topics: Conflict of Interest, EMA, FDA


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