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.
CITATION STYLE
Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., Granger, C. B., & Moore, T. J. (2015). Assessment and Reporting of Harm. In Fundamentals of Clinical Trials (pp. 255–277). Springer International Publishing. https://doi.org/10.1007/978-3-319-18539-2_12
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