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This article was originally published in The Tan Sheet

Executive Summary

CUNICAL INVESTIGATOR FINANCIAL CONFLICT OF INTEREST DATA should not be disclosed by FDA, at least initially, most members of FDA's Science Advisory Board suggested at a Sept. 9 meeting. The agency asked the board to comment on a number of questions regarding potential conflict of interest in clinical research, including whether FDA should make public the information it receives if financial disclosure is required. The Sept. 9 meeting was held to assist FDA in its preparation of a policy on clinical investigator financial interests. The policy guide is scheduled to be issued this year in the form of a notice of proposed rulemaking. A discussion paper distributed at the meeting explains that "at present, FDA has no information concerning specific financial interests of clinical investigators who conduct studies" submitted to the agency. Science board member Dennis Thompson, PhD, Harvard University, said "the ultimate aim" of the policy "should be public disclosure, but I would suggest going slowly on this. . . . You would maximize the disclosure if you could assure people that [for the first two years FDA'S] plan is not to make this public but to use it within the agency. And then [the agency] could decide what kinds of situations really would require disclosure to the public and what wouldn't." William Brody, MD/PhD, Johns Hopkins, also argued in favor of keeping the data confidential at first, but wondered whether measures such as the Sunshine Act could make this difficult. Five of nine advisory board members generally concurred with Thompson and Brody. Of the balance, one member spoke strongly against any public disclosure whatsoever and one argued for full public disclosure. An Aug. 18 letter from FDA to those invited to speak at the meeting explains that the agency "has concluded that it is reasonable to consider requiring sponsors to disclose certain information about financial arrangements to, at the very least, help guide [FDA's] data audits; perhaps to strengthen protocols to control for bias; and finally, to consider whether or not certain financial arrangements are so problematic as to be unmanageable and for that reason disallowed on a case-by-case basis." The letter, from FDA Senior Advisor for Science Elkan Blout, PhD, floats some specific details of FDA's upcoming proposed rule. According to the letter, the notice would "propose that sponsors certify that: a) they have not entered into financial arrangements in which the compensation received by the clinical investigator might be influenced by the outcome of the research; b) no clinical investigator has any direct financial interest in the product being tested, such as a patent; and c) no clinical investigator's equity interest in the sponsoring company is more than 5% of total equity." "In the absence of such certification," the letter continues, sponsors would "seek disclosure from the sponsor of the specific financial arrangements or interests involved and the steps that have been taken to minimize the potential for bias." The group could identify no specific form of compensation that would cause the automatic disqualification of a study, and generally suggested a case-bycase examination. However, Paul Stolley, MD, University of Maryland, suggested that sponsor royalties to investigators, or equities in startup companies, would be "strong red flags" suggesting scrutiny. Currently, the National Science Foundation and the National Institutes of Health are in the process of developing a conflict of interest policy and regulations, respectively. However, their perspectives concern technology transfer rather than regulatory concerns. Congress has mandated that HHS' Agency for Health Care Policy and Research develop a regulation that would define conflict of interest and describe the action the agency would take in cases of conflict of interest, and also has required that the NIH regs be issued by December. The FDA examination of investigator financial conflict of interest issues was engendered by a June 1991 report by the HHS Inspector General that concluded that FDA's lack of policy in the area constituted a "material weakness." The Public Health Service in September 1991 questioned the IG's conclusion but agreed that the issue would be investigated.

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