Data and safety monitoring committees in clinical trials
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : Jay Herson
- ناشر : Boca Raton, FL : Chapman & Hall/CRC,
- چاپ و سال / کشور: 2009
- شابک / ISBN : 9781420070378
Description
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.
Focuses on the practical clinical and statistical issues that arise in pharmaceutical industry trials. This book explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. It also how physicians think differently about safety data than statisticians.
