EARLY STOPPING OF CLINICAL TRIALS

NIH RePORTER · NIH · R01 · $69,079 · view on reporter.nih.gov ↗

Abstract

The major purpose of this research is to formulate the best way that sequential designs can be implemented in clinical trials when the major endpoint of interest is length of survival. We propose to develop a computer algorithm which will find the sequential design which minimizes either total accrual or time to termination of a study, while still preserving the overall level of significance and power to detect a clinically significant difference. We also propose to develop methodology for deriving the exact sequential distribution of nonparametric test statistics, computed after groups of observations. This will be used for deriving exact group sequential tests with studies that have moderate sample size. Finally, we will investigate the bias of fixed sample inference following a group sequential test and indicate how to adjust the inference to minimize the bias.

Key facts

NIH application ID
3174017
Project number
5R01CA036446-06
Recipient
DANA-FARBER CANCER INST
SAM.gov UEI
DPMGH9MG1X67
Principal Investigator
ANASTASIOS A TSIATIS
Activity code
R01
Funding institute
NIH
Fiscal year
1989
Award amount
$69,079
Award type
5
Project period
1983-08-01 → 1989-12-31