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Lack of inspection raises concerns over drug trials

Nature volume 449, page 521 (2007)Cite this article

Incomplete data, lack of coordination and poor follow-up are hampering the overseeing of clinical trials by the US Food and Drug Administration (FDA), says a government report.

The 28 September report ? from the inspector-general's office in the department that oversees the FDA ? found that the agency has no comprehensive database of the clinical trials it requires of companies developing new drugs and devices. On the basis of information in a National Institutes of Health trials registry, the report said that the FDA probably inspected fewer than 1% of all such trial sites between 2000 and 2005.

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Lack of inspection raises concerns over drug trials. Nature 449, 521 (2007). https://doi.org/10.1038/449521b

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