Investigators from McGill University, Montreal Canada report that physicians may be placing too much emphasis on findings from small, early studies from commercial sponsors. Several small studies that explored additional, off-label indications for pregabalin (Lyrica, Pfizer) and were promoted as promising but were never confirmed in subsequent, confirmatory research according to a systematic new study.

McGill researchers reviewed 238 total trials of pregabalin for nonapproved indications, 63 percent of 27 studies “potentially generated uncertainty about the efficacy of pregabalin that was not addressed” within 5 years in any subsequent confirmatory study. The researchers are considered for the many scenarios where a physician may read a journal or magazine and view a positive trial summary report. However, they may not realize that the trial is one of many trials testing the same drug. The researchers caution physicians to be careful about making any assumptions about the efficacy, safety and effectivity of a drug unless the drug has been tested in a large and confirmatory trial or unless the drug shows major effects and the small study had rigorous design.

Lead Research/Investigator

Jonathan Kimmelman, PhD, professor and director of the Biomedical Ethics Unit in the Department of Social Studies


Source: Jama Network

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