NEWS - FDA not effectively monitoring investigator conflicts of interest

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FDA Not Effectively Monitoring Investigator Conflicts of Interest, HHS

Watchdog Says

January 16, 2009 — More than one third of new drug marketing

applications approved by the US Food and Drug Administration (FDA)

were missing information about potential conflicts of interest for

clinical trial investigators, which could allow bias to creep into the

approvals process, a government report released this week has found.

The FDA has said that it agrees with most of the report's findings.

Federal regulations require clinical trial sponsors to collect

financial information from investigators at the outset of trials, and

to report on their efforts to minimize the possibility that financial

self-interest could color trial results, notes the report from the

office of R. Levinson, Inspector General of the Department of

Health and Human Services (HHS).

Trial sponsors — usually the company developing or licensing the drug

or device in question — only have to disclose this information when

they apply for marketing approval, and even then there's a loophole:

they can claim that they " acted with due diligence " to collect

financial information from each investigator to satisfy regulations.

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Read the full Medscape article here:

http://www.medscape.com/viewarticle/586980

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