When planning prospective clinical trials, one of trickiest challenges facing researchers lies in picking the right targets and drugs. In planning a prevention trial, for example, they must integrate strict safety requirements with data from existing research while also minimizing the possibility that future studies conducted during the trial’s multi-year duration will not call into question the original design.
This perennial problem was underscored recently, when the Washington-based consumer advocacy group Public Citizen sent an open letter to the Department of Health and Human Services, recommending that an ongoing 7-year AD prevention trial of two non-steroidal anti-inflammatory drugs be suspended. The letter charged that the drugs tested in this multicenter trial, naproxen and celecoxib, had insufficient scientific support and that the informed consent document used to enroll trial participants was inadequate. (See at http://www.citizen.org/publications/release.cfm?ID=7195.)
The Alzheimer Research Forum interviewed the study’s principal investigator, John Breitner of University of Washington, Seattle, about the issues underlying this letter. The Breitner Q&A and comments from 11 other scientists in the field appear below.-Gabrielle Strobel.
ADAPT: Read the Official Response from NIA (.pdf) to Government Watchdog Group
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