Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team
| Autor: | Ernest S Harpur, Devan V. Mehrotra, Eileen C King, Manfred Oster, Jesse A. Berlin, Robert C Schriver, Juergen Kuebler, David B. Hall, Hongliang Shi, Zhengqing Li, Brenda J. Crowe, Jane B Porter, Nancy C. Santanello, Douglas J. Watson, H. Amy Xia, George Rochester, Stephen L Lin |
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| Rok vydání: | 2009 |
| Předmět: |
Safety Management
Biomedical Research Process management Drug-Related Side Effects and Adverse Reactions Standardization MEDLINE Plan (drawing) Clinical Protocols Meta-Analysis as Topic Drug Discovery Humans Medicine Pharmaceutical industry Pharmacology Biological Products Clinical Trials as Topic Vaccines Data collection business.industry Management science Data Collection General Medicine Special Interest Group Research Design Safety planning business |
| Zdroj: | Clinical Trials. 6:430-440 |
| ISSN: | 1740-7753 1740-7745 |
| DOI: | 10.1177/1740774509344101 |
| Popis: | Background The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America. Purpose SPERT’s goal was to propose a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period. Methods SPERT’s recommendations are based on our review of relevant literature and on consensus reached in our discussions. Results An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data collection and study design. We describe a 3-tier system for signal detection and analysis of adverse events and highlight proposals for reducing "false positive" safety findings. We recommend that sponsors review the aggregated safety data on a regular and ongoing basis throughout the development program, rather than waiting until the time of submission. Limitations We recognize that there may be other valid approaches. Conclusions The proactive approach we advocate has the potential to benefit patients and health care providers by providing more comprehensive safety information at the time of new product marketing and beyond. Clinical Trials 2009; 6: 430—440. http://ctj.sagepub.com |
| Databáze: | OpenAIRE |
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