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Executive Summary

PARALLEL TRACK: RANDOMIZATION TO DIFFERENT DRUG DOSES and different treatments in the expanded access arm of a parallel track study program could provide FDA with better data on which to base AIDS drug approvals, FDA Anti-Viral Drug Products Division Director Ellen Cooper, MD, suggested June 23 at the Sixth International Conference on AIDS. "To improve the likelihood of obtaining more useful data from parallel track protocols, they might be amended or supplemented, at least at selective centers, to improve collection of hard quality data, ideally within the context of an ongoing data collection system, possibly incorporating randomization to different doses of the drug or to different experimental agents," she said. The parallel track drug development system was published as a proposed policy statement on May 21. Under the policy, certain drugs would be eligible for release to selected patients unable to participate in clinical trials once Phase II studies are begun. The policy has generally been interpreted as providing for a protocol that would not involve any randomization. The comparative dose concept, however, appears to be gaining interest at FDA. Office of Drug Evaluation I Director Robert Temple, MD, recently raised the idea of comparing two doses in a Treatment IND protocol at a Drug Information Association meeting ("The Pink Sheet" June 11, p 10). Discussing the advantages of collecting the additional data in the expanded access protocol, Cooper noted that "this concept of nested studies within an expanded access not new and would not replace the need for adequate and well-controlled studies of the more traditional sort." However, she suggested that such an approach "should improve the value of data collected under expanded access availability protocols and thereby increase their attractiveness to sponsors, the community of affected patients, and others interested in the development of better drugs to treat HIV disease." The idea of collecting additional data in expanded access protocols has also been supported by AIDS activists. Dubbing such an approach "middle track," the activist group ACT UP called for collection of additional data (such as information on different doses) in expanded protocols in their "AIDS Treatment Research Agenda" for 1990, which was released at the conference. During the conference session on parallel track, ACT UP representatives objected to Roche's expanded access program for ddC, which began June 25. The group feels that the company's protocol is unduly restrictive because the program limits access to patients who have failed on both AZT and ddI.

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