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CLINICAL INVESTIGATOR INDEPENDENCE CERTIFICATION BEING CONSIDERED BY FDA

This article was originally published in The Gray Sheet

Executive Summary

Sponsor certification of clinical investigator independence is one approach under consideration by FDA to address conflict-of- interest concerns. FDA will float the certification idea in a draft policy to be issued later this year. FDA proposed the idea of certification in a draft response to a May 27 letter on financial disclosure sent to FDA Commissioner David Kessler by House Small Business regulation subcommittee Chairman Ronald Wyden (D-Ore.). The subcommittee held a hearing on conflict-of-interest issues on June 17 (see related item, In Brief). Under the proposed policy, sponsors would have the option of certifying the financial independence of clinical investigators or fully disclosing any financial relationship the clinician has with the company. In his letter to the commissioner, Wyden suggested that "some disclosure of those financial ties, and the conflicts-of-interest, be made to [FDA] at the time trial information is evaluated." He added that "a little sunlight may be the best possible disinfectant in such conflict-of-interest matters." FDA held a series of meetings beginning in late March with consumer representatives, physician associations and regulated industry, including the Health Industry Manufacturers Association, on financial disclosure by clinical investigators. In a background paper prepared for the meetings, FDA states that it "believes that there are potential sources of bias that may directly or indirectly influence the outcomes of research." The agency cites certain checks and balances currently included in the evaluation process, including its bioresearch monitoring program, but notes that "no information is available to the agency with respect to financial holdings of clinical investigators." FDA asked the meeting attendees for advice on a number of points, including whether it should require the submission of information on financial interests, at what point during the review process the financial information should be disclosed and information on the ways in which sponsors compensate investigators.

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