FDA says study overestimated non-compliance with data-reporting laws

US drug regulator finds no evident harm caused by sponsors failing to post drug-trial data.

Nature.com: Meredith Wadman, May 1, 2012.

The US Food and Drug Administration (FDA) and National Institutes of Health have disputed charges that sponsors are under-reporting clinical-trial results. The letters to Congress, obtained by Nature under the Freedom of Information Act, come in response to questions raised after a study in theBritish Medical Journal (BMJ)1, reported that, in 2009, only 22% of trial sponsors posted their results within one year of completion, as the law requires.

The provision of the FDA Amendments Act seemed simple enough when it was passed in 2007: sponsors of clinical trials of already-approved drugs would be required to post their results in a public database. That database, ClinicalTrials.gov, maintained by the NIH, would be the user-friendly storehouse for detailed information on all but the earliest, phase I, safety trials of drugs, devices and biologics. Read more