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April 25, 2001

Safety Reporting in Clinical Trials

Author Affiliations

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


Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001

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

To the Editor: Drs Ioannidis and Lau1 recommend publication guidelines to promote more complete safety reports. Their conclusions are based on investigator-defined indicators of reporting completeness. While the qualitative indicators address important aspects of safety reporting, their quantitative measure of data completeness (extent of article space devoted to safety) seems contrived.

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