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The use of group sequential designs with common competing risks tests. Stat Med 2013 Mar 15;32(6):899-913

Date

09/05/2012

Pubmed ID

22945865

Pubmed Central ID

PMC3574186

DOI

10.1002/sim.5597

Abstract

Clinical trials are often performed using a group sequential design in order to allow investigators to review the accumulating data sequentially and possibly terminate the trial early for efficacy or futility. Standard methods for comparing survival distributions have been shown under varying levels of generality to follow an independent increments structure. In the presence of competing risks, where the occurrence of one type of event precludes the occurrence of another type of event, researchers may be interested in inference on the cumulative incidence function, which describes the probability of experiencing a particular event by a given time. This manuscript shows that two commonly used tests for comparing cumulative incidence functions, a pointwise comparison at a single point, and Gray's test, also follow the independent increments structure when used in a group sequential setting. A simulation study confirms the theoretical derivations even for modest trial sample sizes. We used two examples of clinical trials in hematopoietic cell transplantation to illustrate the techniques.

Author List

Logan BR, Zhang MJ

Authors

Brent R. Logan PhD Director, Professor in the Institute for Health and Equity department at Medical College of Wisconsin
Mei-Jie Zhang PhD Professor in the Institute for Health and Equity department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Blood Platelets
Clinical Trials as Topic
Computer Simulation
Cord Blood Stem Cell Transplantation
Fluconazole
Humans
Kidney Diseases
Pyrimidines
Research Design
Risk
Sample Size
Statistics as Topic
Triazoles
Voriconazole
jenkins-FCD Prod-409 d1e206b0be345926047b0d9c353c78a4cce4058b