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Executive Summary

FDA SCIENCE ADVISORY BOARD SEPT. 9 MEETING ON FINANCIAL DISCLOSURE by clinical trial investigators will be held in Bethesda, Md., an Aug. 25 Federal Register notice states. "There is a growing recognition that certain kinds of payment arrangements for clinical trials, such as those that implicitly result in a higher fee for a particular outcome (e.g., equity, stock option, or royalty payments), have the potential to bias the outcome of trials," the notice states. The board will "examine the broad concepts" behind the issue of clinical investigator financial disclosure at the meeting, the notice adds. Later this fall, FDA plans to issue a notice of proposed rulemaking on financial disclosure by clinical trial investigators. Last year, FDA established a task force headed by Deputy Commissioner for External Affairs Carol Scheman to address clinical investigator financial disclosure ("The Pink Sheet" Dec. 21, 1992, T&G-9). The board agreed in May at the request of Commissioner Kessler to address the issue of investigator independence from sponsors at its autumn meeting ("The Pink Sheet" May 31, T&G-9). Both the National Institutes of Health and the National Science Foundation are in the process of developing positions on the definition and disclosure of conflicts of interest. The NIH reauthorization act, signed by President Clinton June 10, stipulates that NIH must have conflict of interest guidelines in place by Dec. 7. NIH reportedly submitted its proposed guidelines to HHS the week of July 19. NSF finalized its financial conflict of interest policy and sent it to the Office of Management & Budget for clearance about one month ago. However, NSF is looking at the possibility of working with NIH to develop a uniform approach as requested in many comments on NSF's proposed policy. NIH and NSF's roles in relation to investigator conflict of interest differ from FDA's in that NIH and NSF distribute grant funding. FDA is primarily concerned about the integrity of clinical data submitted to the agency. The FDA Science Advisory Board meeting will be held at the Bethesda Ramada Inn, Ambassador Rooms I and II, at 8400 Wisconsin Ave. The meeting is slated to run between 8 a.m. and 5 p.m., with the majority of the day devoted to open committee discussion. An open public hearing is scheduled for 2:30-3:30 p.m.

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