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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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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DOI: https://doi.org/10.1007/978-1-4614-5245-4_10
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