Inspector General: FDA flunking clinical trials oversight

A linkurl:report;http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf released today by the Department of Health and Human Services reveals that the linkurl:FDA;http://www.the-scientist.com/article/display/36885/ is woefully lax in monitoring clinical trials research, according to the linkurl:New York Times.;http://www.nytimes.com/2007/09/28/health/policy/28fda.html?ref=health The article reports that agency officials don't know how many clinical trials are going, and that just 200 inspecto

By | September 28, 2007

A linkurl:report;http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf released today by the Department of Health and Human Services reveals that the linkurl:FDA;http://www.the-scientist.com/article/display/36885/ is woefully lax in monitoring clinical trials research, according to the linkurl:New York Times.;http://www.nytimes.com/2007/09/28/health/policy/28fda.html?ref=health The article reports that agency officials don't know how many clinical trials are going, and that just 200 inspectors oversee 350,000 trials. They audited fewer than 1 percent of all sites, generally after the trials were complete, and rarely followed up with trial sites about problems they identified. The article also notes - and illustrates with a troubling example - that the agency conducts no oversight at all over "privately funded noncommercial" trials, creating a fractured system in which patients subject to ethical abuses have little recourse.
Advertisement
Advertisement

Popular Now

  1. Opinion: Making Progress by Slowing Down
  2. A Case of Sexual Ambiguity, 1865
    Foundations A Case of Sexual Ambiguity, 1865

    This year marks the 150th anniversary of an autopsy report describing the first known case of a sexual development disorder.

  3. Influential Cancer Biologist Dies
  4. Image of the Day: Colorful Corn
Advertisement
Advertisement
Life Technologies