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CLINICAL INVESTIGATOR INDEPENDENCE CERTIFICATION BY SPONSORS

Executive Summary

CLINICAL INVESTIGATOR INDEPENDENCE CERTIFICATION BY SPONSORS is being considered by FDA to assure that clinicians conducting studies are free of financial holdings in the company sponsoring the trial. Certification of independence is one idea that will be floated in a draft policy statement on investigator conflict of interest to be issued later this year. FDA proposed the idea of certification in a response drafted to a May 27 letter to FDA Commissioner Kessler from House Small Business Committee/Regulation Subcommittee Chairman Wyden (D-Ore.) on financial disclosure. The subcommittee held a hearing on conflict-of-interest issues on June 17 (see related stories, pp. 8-10). Under the policy, sponsors would have the option of certifying the financial independence of clinical investigators in drug studies or fully disclosing any financial relationship the clinician has with the company. In his letter to Kessler, 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 as part of the IND or NDA process." He added that "a little sunlight may be the best possible disinfectant in such conflict-of-interest matters." Wyden said that he is specifically concerned about conflicts of interest as they relate to high drug prices. He asked FDA to summarize all cases reviewed by the agency in the last 10 years "in which clinical trials were biased, fabricated, manipulated or otherwise adjusted in order to assist the applicant in gaining approval for the drug, or with the obvious intent of increasing the drug's prospective sales or profit." The congressman cites as an example of the relationship between conflict of interest and high drug prices the allegation that certain clinical investigators in the pivotal trial for Genzyme's Ceredase in Gaucher's disease had financial arrangements with the company. Wyden argued that the doses used in the pivotal trial were higher than necessary; he noted that Genzyme and FDA are currently working on new dosing instructions (see preceding T&G). FDA held a series of meetings beginning in late March with consumer representatives, physicians associations and regulated industry -- including the Pharmaceutical Manufacturers Association the Biotechnology Industry Organization and the Health Industry Manufacturers Association -- on financial disclosure by clinical investigators ("The Pink Sheet" April 5, T&G-9). 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 paper notes that FDA already "imposes a variety of requirements designed to minimize bias and ensure that the product approval data FDA receives are not compromised." FDA admitted, however, that "no information is available to the agency with respect to financial holdings of clinical investigators." FDA said that it is "considering requiring sponsors of product applications to provide information to FDA on specific financial interests of clinical investigators who conduct studies in support of these applications." The agency states in the backgrounder that its goals in developing the policy are: "to require FDA evaluation of information about financial arrangements between clinical investigators and sponsors in an effort to prevent these interests from jeopardizing the validity of investigational research results"; "to assure the public that these financial interests are carefully and fairly managed"; and "to assure that sponsors know about potential bias among their clinical investigators so that they can take appropriate steps to eliminate inappropriate conflicts of interest."
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