Data and safety monitoring committees in clinical trials /
Jay Herson
- Boca Raton, FL : Chapman & Hall/CRC, c2009
- xviii, 173 p. : ill. ; 25 cm.
- Chapman & Hall/CRC biostatistics series ; 30 .
- Chapman & Hall/CRC biostatistics series ; 30 .
Includes bibliographical references (p. 155-166) and index
Introduction -- Organization of a safety monitoring program for a confirmatory trial -- Meetings -- Clinical issues -- Statistical issues -- Bias and pitfalls -- Data monitoring committee decisions -- Emerging issues
Drugs--Testing--Evaluation Drugs--Testing--Statistical methods--Evaluation Clinical Trials Data Monitoring Committees--organization & administration Clinical Trials as Topic--standards Data Collection Drug Industry--standards Research Design Safety Management