Data monitoring committees and problems of lower-than-expected accrual or events rates

E L Korn; R Simon

doi:10.1016/s0197-2456(96)00088-8

Data monitoring committees and problems of lower-than-expected accrual or events rates

Control Clin Trials. 1996 Dec;17(6):526-35. doi: 10.1016/s0197-2456(96)00088-8.

Authors

E L Korn¹, R Simon

Affiliation

¹ Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, USA.

PMID: 8974211
DOI: 10.1016/s0197-2456(96)00088-8

Abstract

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.

Publication types

Review

MeSH terms

Decision Making*
Decision Support Techniques
Humans
Organizational Policy
Professional Staff Committees*
Randomized Controlled Trials as Topic / methods*
Research Design*
Therapeutic Equivalency