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Safety Reporting in Clinical Trials
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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 . . . [Full Text of this Article]
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