Early stopping rules in oncology: considerations for clinicians

Som D Mukherjee; John R Goffin; Valerie Taylor; Kelly K Anderson; Gregory R Pond

doi:10.1016/j.ejca.2011.05.019

Early stopping rules in oncology: considerations for clinicians

Eur J Cancer. 2011 Nov;47(16):2381-6. doi: 10.1016/j.ejca.2011.05.019. Epub 2011 Jun 16.

Authors

Som D Mukherjee¹, John R Goffin, Valerie Taylor, Kelly K Anderson, Gregory R Pond

Affiliation

¹ Department of Oncology, McMaster University, Juravinski Cancer Centre, Hamilton, Ontario, Canada. [email protected]

PMID: 21684153
DOI: 10.1016/j.ejca.2011.05.019

Abstract

The number of cancer-related clinical trials has been rapidly increasing over the past decade. Along with this increase, oncology studies stopped early for benefit or harm have also been more common. Clinicians treating cancer patients often are faced with the challenge of having to decide whether or not to incorporate information from these new studies into their daily clinical practice. This review article explains the role of the Data and Safety Monitoring Committee in stopping trials early; provides examples of oncology trials stopped early; and reviews some of the controversies and statistical concepts associated with early stopping rules. In addition, a simple and practical approach to interpreting the findings of trials that are stopped early is provided to assist clinicians in deciding how to incorporate information from these studies into their daily practice.

Publication types

Review

MeSH terms

Bayes Theorem
Clinical Trials Data Monitoring Committees*
Data Interpretation, Statistical
Early Termination of Clinical Trials / methods
Early Termination of Clinical Trials / standards*
Early Termination of Clinical Trials / statistics & numerical data
Ethics, Medical
Humans
Randomized Controlled Trials as Topic* / ethics
Randomized Controlled Trials as Topic* / statistics & numerical data