Adverse event detection in drug development: recommendations and obligations beyond phase 3
| Autor: | Susan Glasser, Jesse A. Berlin, Susan S. Ellenberg |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Insurance Claim Reporting
Marketing Research Innovations and Recommendations medicine.medical_specialty Clinical Trials Phase I as Topic Drug Industry Drug-Related Side Effects and Adverse Reactions business.industry Medical record Public Health Environmental and Occupational Health MEDLINE Postmarketing surveillance Phase (combat) Clinical trial Epidemiologic Studies Drug development Clinical Trials Phase III as Topic Pharmacovigilance Product Surveillance Postmarketing Medicine Adverse Drug Reaction Reporting Systems Humans business Intensive care medicine Adverse effect |
| Zdroj: | American journal of public health. 98(8) |
| ISSN: | 1541-0048 |
| Popis: | Premarketing studies of drugs, although large enough to demonstrate efficacy and detect common adverse events, cannot reliably detect an 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. |
| Databáze: | OpenAIRE |
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