A 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 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.
Kittelson
J M
JM
Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.
Emerson
S S
SS
D001699:Biometry; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D006801:Humans; D016634:Radiosurgery / Q000009:adverse effects; D012449:Safety; D013125:Spinal Neoplasms / Q000601:surgery