Issues in regulatory guidelines for data monitoring committees
| Autor: | Frank W. Rockhold, Dennis O. Dixon, Richard Kaplan, David Stump, Thomas Fleming, James D. Neaton, Stuart J. Pocock, Desmond G. Julian, Milton Packer, Peter Held, David L. DeMets, Jay P. Siegel, Richard J. Whitley, Belinda Seto, Robert J. Levine, Susan S. Ellenberg, Robert M. Califf, Steve Snapinn, Robert Temple |
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| Rok vydání: | 2005 |
| Předmět: |
medicine.medical_specialty
Alternative medicine Psychological intervention MEDLINE Guidelines as Topic computer.software_genre 01 natural sciences 010104 statistics & probability 03 medical and health sciences 0302 clinical medicine Research Support as Topic medicine Data monitoring committee Humans 030212 general & internal medicine 0101 mathematics health care economics and organizations Pharmacology Clinical Trials as Topic business.industry United States Food and Drug Administration General Medicine United States Clinical trial Intervention (law) Clinical research Engineering ethics Data mining business Clinical Trials Data Monitoring Committees computer Statistician |
| Zdroj: | Clinical trials (London, England). 1(2) |
| ISSN: | 1740-7745 |
| Popis: | As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the standard approach to implement this responsibility for many Phase III trials. Recent draft guidelines on the operation of DMCs by the Food and Drug Administration (FDA) have raised issues that need further clarification or discussion, especially for industry sponsored trials. These include, the time when DMCs are needed, the role of the independent statistician to support the DMC, and sponsor participation at DMC meetings. This paper provides an overview of these issues, based on the discussions at the January, 2003 workshop sponsored by Duke Clinical Research Institute. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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