US new drug applications increasingly rely on trials conducted abroad

BMJ 2010; 341 doi: (Published 06 July 2010) Cite this as: BMJ 2010;341:c3616
  1. Janice Hopkins Tanne
  1. 1New York

    Applications to the US Food and Drug Administration for approval of new drugs and biologicals increasingly rely on foreign trials, says a new report.

    The report, from the FDA’s parent organisation—the federal Health and Human Services Administration—says that in 2008, 80% of approved marketing applications contained data from foreign clinical trials and 78% of participants in clinical trials were foreign. Nine drugs and one biological were approved solely on the basis of clinical trials from outside the US.

    The report says, “Western Europe accounted for the most clinical trial subjects and sites; however Central and South America had the highest average number of subjects per site…The percentage of foreign …

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