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Safety Reporting in Clinical Trials

Safety Reporting in Clinical Trials 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 Comprehensive questionnaires increase the likelihood that patient interviews addressing drug safety are conducted in a consistent and nonsuperficial manner. Moreover, they minimize the risk of bias, particularly from focusing on known adverse effects, and can be useful for intersubject and intrasubject comparisons. Also, toxicity criteria developed by the World Health Organization (WHO) and the National Cancer Institute (NCI), among others, provide guidelines for objectively and systematically categorizing adverse effects according to type and severity. The NCI's Common Toxicity Criteria (CTC)4 are particularly useful for studies involving antineoplastic drugs, but are equally applicable to other drug categories. The CTC organizes related adverse events alphabetically according to body system or disease. Specific criteria are provided for grading the severity of each adverse effect. Even under optimal conditions, some adverse reactions will not be detected because of inherent limitations in study scope and design. Nonetheless, a comprehensive plan for clinical trial drug safety evaluation can enhance the quality and value of safety data. References 1. Ioannidis JPALau J Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA. 2001;285:437-443.Google Scholar 2. Corso DMPucino FDeLeo JMCalis KAGallelli JF Development of a questionnaire for detecting potential adverse drug reactions. Ann Pharmacother. 1992;26:890-896.Google Scholar 3. Reidenberg MMLowenthal DT Adverse nondrug reactions. N Engl J Med. 1968;279:678-679.Google Scholar 4. CTEP: Developing Cancer Therapies. Available at: http://ctep.info.nih.gov/CTC3/default.htm. Accessibility verified March 26, 2001. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Safety Reporting in Clinical Trials

JAMA , Volume 285 (16) – Apr 25, 2001

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References (11)

Publisher
American Medical Association
Copyright
Copyright © 2001 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.285.16.2076
Publisher site
See Article on Publisher Site

Abstract

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 Comprehensive questionnaires increase the likelihood that patient interviews addressing drug safety are conducted in a consistent and nonsuperficial manner. Moreover, they minimize the risk of bias, particularly from focusing on known adverse effects, and can be useful for intersubject and intrasubject comparisons. Also, toxicity criteria developed by the World Health Organization (WHO) and the National Cancer Institute (NCI), among others, provide guidelines for objectively and systematically categorizing adverse effects according to type and severity. The NCI's Common Toxicity Criteria (CTC)4 are particularly useful for studies involving antineoplastic drugs, but are equally applicable to other drug categories. The CTC organizes related adverse events alphabetically according to body system or disease. Specific criteria are provided for grading the severity of each adverse effect. Even under optimal conditions, some adverse reactions will not be detected because of inherent limitations in study scope and design. Nonetheless, a comprehensive plan for clinical trial drug safety evaluation can enhance the quality and value of safety data. References 1. Ioannidis JPALau J Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA. 2001;285:437-443.Google Scholar 2. Corso DMPucino FDeLeo JMCalis KAGallelli JF Development of a questionnaire for detecting potential adverse drug reactions. Ann Pharmacother. 1992;26:890-896.Google Scholar 3. Reidenberg MMLowenthal DT Adverse nondrug reactions. N Engl J Med. 1968;279:678-679.Google Scholar 4. CTEP: Developing Cancer Therapies. Available at: http://ctep.info.nih.gov/CTC3/default.htm. Accessibility verified March 26, 2001.

Journal

JAMAAmerican Medical Association

Published: Apr 25, 2001

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