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PLACEBO CONTROL GUIDANCE FOR AIDS CLINICAL TRIALS

Executive Summary

PLACEBO CONTROL GUIDANCE FOR AIDS CLINICAL TRIALS was suggested by the Presidential AIDS Commission report, released March 3. In response to criticism that placebo studies are unethical in patients with advanced stages of the disease, the commission advises that clinicians limit "placebo-controlled studies for HIV-positive asymptomatic or ARC patients," and use "positive control studies in patients with AIDS." To facilitate the design of future studies with a decreased reliance on placebo controls, the panel recommends that the government develop a computerized database with information gathered from placebo arm participants "to formulate the equivalent of a 'historic control' for AIDS." The endpoints in current clinicals trials should be reevaluated in order to determine what other markers may be used, the panel suggested. Standardizing the criteria by which each disease stage is defined would allow for development of other efficacy measures, the commission suggests. "The selection process should favor the staging system that can most accurately establish disease stage and therefore clinical trail end points by laboratory methods," the panel report states. The panel recommendations are scheduled to be forwarded to President Reagan in the form of an interim report during the week of March 7-11. An early version of the report was announced by Commission Chairman James Watkins at a Feb. 24 press conference ("The Pink Sheet" Feb. 29, p. 5). It was approved by the panel on March 3 with minor editorial changes. A final report to the President is due June 24. The recommendation on placebo controls is in line with comments offered by Burroughs Wellcome VP-Research David Barry at a recent commission hearing in New York. In response to a question by Commission Chairman Watkins about the possibility of dropping placebo controls, Barry said: "I think the consensus in the scientific community, and this is supported by a number of discussions at the National Academy of Sciences, Institute of Medicine, FDA and the NIH, is as follows: for patients with AIDS and severe ARC, you should not do placebo-controlled studies, you should do active controlled [studies] with [B-W's] AZT, Retrovir, as the benchmark and the other drug being compared in its ability to improve the longevity and quality of life with Retrovir." National Cancer Institute Clinical Oncology Program Associate Director Samuel Broder has publicly supported discontinuation of placebo trials in AIDS patients. Barry continued: "I think there is also agreement, that for patients who have milder forms of HIV infection, who are less in danger of immediate death, then placebo-controlled studies can be accepted. The one area I know of where there's any controversy at all, is in those patients who have neurologic disease, whether it's justified to give a placebo there or not, I don't think there's an easy answer to that discussion because I think it's being worked out now."

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