Data monitoring committees and problems of lower-than-expected accrual or events rates.
Data monitoring committees for randomized clinical trials must frequently decide what action, if any, is required for trials whose accrual has been slower than expected, or whose event rates have been less than expected. We discuss in this article some of the practical issues concerning modifying or closing such trials, including what data and analyses could be helpful to the data monitoring committee in their deliberations.
Korn
E L
EL
Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, USA.
Simon
R
R
D003657:Decision Making; D003661:Decision Support Techniques; D006801:Humans; D016134:Organizational Policy; D011367:Professional Staff Committees; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D013810:Therapeutic Equivalency