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Health Agencies Update
April 16, 2003

FDA Clinical Trial Investigated

JAMA. 2003;289(15):1915. doi:10.1001/jama.289.15.1915-a

The US Food and Drug Administration (FDA) has taken the unusual step of asking its parent agency, the Department of Health and Human Services, to investigate one of its own clinical trials for lapses in patient record handling (http://www.fda.gov/oc/mcclellan/navalacademy.html).

According to an FDA statement, 92 of 260 patient files were missing in the study of a dietary strategy to maximize bone mass in US Naval Academy students. The FDA also asked for an investigation into the study's "financial integrity."