Data and safety monitoring committees in clinical trials /
Herson, Jay
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
9781420070378 (hardcover : alk. paper) 1420070371 (hardcover : alk. paper)
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
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
9781420070378 (hardcover : alk. paper) 1420070371 (hardcover : alk. paper)
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