Independent data monitoring committees: rationale, operations and controversies

Data monitoring committees (DMCs) have become an increasingly common compon ent of randomized clinical trials in recent years. As experience has accumu lated, and more individuals and organizations have become involved in such activities, a variety of approaches to the operation of such committees has inevitably arisen. Because these committees play such a critical role in t he process of new drug development, it is important to consider the implica tions of the different approaches that are being used. It is also timely to consider the present and possible future regulatory status of data monitor ing committees. Published in 2001 by John Wiley & Sons, Ltd.