Unifying Family of Group Sequential Test Designs

Currently, the design of group sequential clinical trials requires choosing among several distinct design categories, design scales, and strategies for determining stopping rules. This approach can limit the design selection process so that clinical issues are not fully addressed. This paper describ...

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Bibliographic Details
Published in:Biometrics 1999-09, Vol.55 (3), p.874-882
Main Authors: Kittelson, John M., Emerson, Scott S.
Format: Article
Language:English
Subjects:
Biometrics
Biometry
Clinical trials
Clinical Trials as Topic - statistics & numerical data
Computer software
Critical values
Design analysis
Equivalence relation
Error-spending functions
Group sequential designs
Humans
Hypothesis test
Null hypothesis
Radiosurgery - adverse effects
Safety
Sample mean
Sample size
Shape functions
Software
Spinal Neoplasms - surgery
statistics
Stopping rules
Unification
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Summary:Currently, the design of group sequential clinical trials requires choosing among several distinct design categories, design scales, and strategies for determining stopping rules. This approach can limit the design selection process so that clinical issues are not fully addressed. This paper describes a family of designs that unifies previous approaches and allows continuous movement among the previous categories. This unified approach facilitates the process of tailoring the design to address important clinical issues. The unified family of designs is constructed from a generalization of a four‐boundary group sequential design in which the shape and location of each boundary can be independently specified. Methods for implementing the design using error‐spending functions are described. Examples illustrating the use of the design family are also presented.
ISSN:0006-341X
1541-0420
DOI:10.1111/j.0006-341x.1999.00874.x