Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author's experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC

chapter 1|16 pages


chapter 3|16 pages


chapter 4|10 pages

Clinical Issues

chapter 5|32 pages

Statistical Issues

chapter 6|12 pages

Bias and Pitfalls

chapter 7|18 pages

Data Monitoring Committee Decisions

chapter 8|16 pages

Emerging Issues