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CLINICAL TRIAL DESIGN TRENDS: COMPUTERIZED DATA BASES

Executive Summary

CLINICAL TRIAL DESIGN TRENDS: COMPUTERIZED DATA BASES of drug use information will be useful for discovering potential new indications, but should not be viewed as a replacement for randomized clinical trials, FDA Office of Drug Evaluation I Director Robert Temple, MD, told a March 22 "Foresight Seminar." Temple said he "would hope" that linked computerized physician data bases of patient information "would be taken as hypothesis-generating systems, much as the intelligent physician observer is, and would not, at least without a lot more evidence," be taken as supportive evidence of an experimental use. The FDAer explained that while the trend of computerizing patient data at the physicians office could provide useful information about adverse experiences and new uses, such information cannot be controlled for bias, and therefore should be replicated with randomized trials. "When you're in control of the data base, as you always are in these kinds of trials, it's always possible for optimism and other kinds of biases to creep in," Temple said. Organized by the Institute of Alternative Futures, the seminar focused on new methodologies for clinical trials in the 1990's. Temple identified two trends in clinical trial design he sees for the next decade: larger trials measuring fewer clinical endpoints, and pooling of trial data. The advantage of a very large, yet simple, randomized trial "is that it allows one to look at effects of meaningful, but not very large, size that you simply can't look at in trials with only 1,000 patients," Temple said. The European community has been making use of very large, yet inexpensive, randomized trial designs for the last decade, Temple said, noting that "one interesting question is whether the same attitude can be brought to the U.S., because we have for the most part not been participating." The second trend, "the resurrection of pooling as a legitimate endeavor," will continue to grow in use because "the ways of doing that responsibly have been laid out," Temple commented. The institute's "Foresight Seminars" on pharmaceutical issues are sponsored by Ciba-Geigy, Glaxo, Merrell Dow, Pfizer, Sterling and Upjohn.

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