Adverse event detection in drug development: recommendations and obligations beyond phase 3.
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| Title: | Adverse event detection in drug development: recommendations and obligations beyond phase 3. |
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| Authors: | Berlin JA (AUTHOR), Glasser SC (AUTHOR), Ellenberg SS (AUTHOR) |
| Source: | American Journal of Public Health. Aug2008, Vol. 98 Issue 8, p1366-1371. 6p. |
| Subjects: | Drug development, Pharmacology, Drug side effects, Drug marketing, Medical records, Medical informatics, Pharmacodynamics, Pharmaceutical policy, Clinical trials |
| Abstract: | Prémarketing studies of drugs, although large enough to demonstrate efficacy and detect common adverse events, cannot reliably detectan increased incidence of rare adverse events or events with significant latency. For most drugs, only about 500 to 3000 participants are studied, for relatively short durations, before a drug is marketed. Systems for assessment of postmarketing adverse events include spontaneous reports, computerized claims or medical record databases, and formal postmarketing studies. We briefly review the strengths and limitations of each. Postmarketing surveillance is essential for developing a full understanding of the balance between benefits and adverse effects. More work is needed in analysis of data from spontaneous reports of adverse effects and automated databases, design of ad hoc studies, and design of economically feasible large randomized studies. [ABSTRACT FROM AUTHOR] |
| Copyright of American Journal of Public Health is the property of American Public Health Association and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
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