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Past, Present, and Future of Drug Safety Assessment

  • Conference paper
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Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials

Part of the book series: Lecture Notes in Statistics ((LNSP,volume 1205))

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Abstract

Adverse effects are an expected consequence of drug use, but how to detect them when they are rare or represent only a small increase over background rates remains a formidable problem. It is useful to review the past history of how important adverse effects were discovered so that we can improve our ability to detect them more rapidly.

We discover serious adverse effects in different ways, depending on how rare they are and whether they occur spontaneously (i.e., in the absence of a drug), and on how great the increase over background rate is. Depending on such factors we rely on spontaneous reports, epidemiologic data (if the risk increase is reasonably large), and on large controlled trials or meta-analyses (when the increase in risk is smaller).

These methods, the history of their use, and their usefulness in the future are considered.

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Author information

Authors and Affiliations

  1. Center for Clinical Science, FDA Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD, 20993-0002, USA

    Robert Temple

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  1. Robert Temple
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Correspondence to Robert Temple .

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Editors and Affiliations

  1. University of Washington, Department of Biostatistics, Seattle, 98195-7232, Washington, USA

    Thomas R. Fleming

  2. University of Washington, Department of Biostatistics, Seattle, 98195-7232, Washington, USA

    Bruce S. Weir

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Temple, R. (2013). Past, Present, and Future of Drug Safety Assessment. In: Fleming, T., Weir, B. (eds) Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials. Lecture Notes in Statistics(), vol 1205. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-5245-4_10

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