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April 25, 2001

Safety Reporting in Clinical Trials

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;285(16):2076-2078. doi:10.1001/jama.285.16.2076

To the Editor: We agree with Drs Ioannidis and Lau1 that the quality and quantity of safety reporting in randomized trials is often inadequate. Clinical research in human immunodeficiency virus (HIV) infection has shown that during clinical trials even frequent adverse effects were often initially overlooked because patients were not systematically questioned about specific symptoms nor examined for clinical signs. For example, lipodystrophy was discovered only as a complication of protease inhibitor treatment after these drugs were already licensed.2 Sexual dysfunction was detected as an adverse effect of protease inhibitor use more than 2 years after these drugs became widely available.3,4

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