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Regarding Registration of Clinical Trials—Reply
Leonard A. Levin, MD, PhD
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In reply
Dr Palmowski-Wolfe asks how clinical trial registration will improve ethics if there is no way to enforce publication of all trial results, both positive and negative. Yes, publication, or at least dissemination, of all trial results is a better method for making sure that the results of studies are not hidden. But even if a trial is never published, it can still be discovered if it is registered, and in this way the unpublished findings can be uncovered.
As far as potential loss of intellectual property is concerned, clinical trial registration is only required for some phase 2 and all phase 3 trials. By this time, most of the drug discovery process as well as toxicity and other early studies are done. In addition, participants are aware of the trial arms as required by informed consent, and they cannot be made to keep . . . [Full Text of this Article] AUTHOR INFORMATION
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