Assessment and Reporting of Harm

Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger and Thomas J. Moore
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Curt D. Furberg: Wake Forest School of Medicine, Division of Public Health Sciences
David L. DeMets: University of Wisconsin, Department Biostatistics and Medical Informatics
David M. Reboussin: Wake Forest School of Medicine, Department of Biostatistics
Christopher B. Granger: Duke University, Department of Medicine
Thomas J. Moore: Institute for Safe Medication Practices

Chapter Chapter 12 in Fundamentals of Clinical Trials, 2015, pp 255-277 from Springer

Abstract: Abstract Assessment of harm is more complex than the assessment of benefit of an intervention. The measures of favorable effects are or should be prespecified in the protocol and they are limited in number. In contrast, the number of adverse events is typically very large and they are rarely prespecified in the protocol. Some may not even be known at the time of trial initiation. These facts introduce analytic challenges.

Date: 2015
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DOI: 10.1007/978-3-319-18539-2_12

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