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Assessing and Reporting Adverse Events

In: Fundamentals of Clinical Trials

Author

Listed:
  • Lawrence M. Friedman

  • Curt D. Furberg

    (Wake Forest University, School of Medicine)

  • David L. DeMets

    (University of Wisconsin, Department of Biostatistics & Medical Informatics)

Abstract

There is no perfectly safe intervention. All treatments result in some adverse events. Their severity ranges from mild symptoms to life-threatening events. Collection of adverse event data in randomized clinical trials is a regulatory requirement and additionally, clinically and scientifically important. The challenge is to know what and how to collect these data, the frequency of collection, and how to deal with small numbers of serious events. There are also potential legal issues to consider, which tend to lead to an over-collection of safety data. On the other hand, there is a marked underreporting of safety information in the published literature. A review of 192 large clinical trials from seven therapeutic areas revealed that the safety reporting was considered adequate in only 39% of the articles [1].

Suggested Citation

  • Lawrence M. Friedman & Curt D. Furberg & David L. DeMets, 2010. "Assessing and Reporting Adverse Events," Springer Books, in: Fundamentals of Clinical Trials, edition 0, chapter 0, pages 215-231, Springer.
    • Handle: RePEc:spr:sprchp:978-1-4419-1586-3_12
    DOI: 10.1007/978-1-4419-1586-3_12
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