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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: Drs Ioannidis and Lau1 describe current inadequacies in presentation of safety data in randomized trials across 7 different medical areas and discuss the need for standardizing how adverse events are defined and reported. We have recently created "The Brighton Collaboration" to meet this need in the realm of immunizations. As the authors point out, randomized trials with adequate sample size are invaluable for rigorous assessment of the safety and efficacy of medical interventions. Unlike efficacy, however, safety cannot be directly measured. It can only be inferred from the relative absence of multiple adverse events, only some of which can be predicted a priori, ranging from mild to severe, across multiple organ systems, and across time. Therefore, safety monitoring is inherently more difficult than measurement of efficacy, and thus the apparent deficiencies are greater.

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