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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 drug safety reporting in medical research is frequently inadequate. This problem is further compounded by inadequate collection and assessment of drug safety data. Detection of adverse reactions during clinical trials requires careful and systematic evaluation of study participants before, during, and after drug exposure. Study protocols should clearly define how adverse events will be identified, managed, and reported. Safety data should be entered on case report forms designed for the study, and a quality control mechanism for ensuring the accuracy and integrity of the data should be established prior to the start of data collection. In addition to the routine data collected during the course of clinical trials (eg, compliance with study regimen, pertinent laboratory tests, diagnostic procedures, medical history and physical examination findings, and complete medication history), adverse drug event questionnaires using extensive checklists of symptoms organized by body system can augment safety data.2 Questionnaires should be administered at baseline and at predetermined intervals during and after a study. To increase their utility and to allow for comparisons between treatment groups, the questionnaires should be administered by a blinded investigator. Since healthy individuals who are not receiving medications can occasionally experience symptoms similar to those reported as drug adverse effects, adequate controls must be used in studies examining adverse drug reactions.3