Design for group sequential phase II clinical trials

M. N. Chang, Terry M Therneau, H. S. Wieand, S. S. Cha

Research output: Contribution to journalArticle

93 Citations (Scopus)

Abstract

The main goal of Phase II cancer clinical trials is to identify the therapeutic efficacy of new treatments. For ethical reasons, group sequential procedures, which allow for early stopping when a treatment is either extremely effective or extremely ineffective, have been widely employed in these trials. Although several useful design methods have been discussed in the literature (Fleming, 1982, Biometrics 38, 143-152; Lee, 1979, Cancer Treatment Reports 63, No. 11-12), we are unaware of any results addressing the problem of finding an optimal rule easily by computer. In this paper, using an idea based on the Neyman-Pearson lemma, we propose a method to search over a restricted set of designs and to select the optimal one in this set according to optimality criteria. In all the combinations we have investigated (more than 100) the optimal design produced by our method is the true global optimum. Other applications are discussed.

Original languageEnglish (US)
Pages (from-to)865-874
Number of pages10
JournalBiometrics
Volume43
Issue number4
StatePublished - 1987
Externally publishedYes

Fingerprint

Group Sequential
Phase II Clinical Trials
Clinical Trials
clinical trials
Oncology
Cancer
Biometrics
Neyman-Pearson Lemma
Early Stopping
Sequential Procedure
neoplasms
Optimality Criteria
Global Optimum
biometry
Design Method
Efficacy
methodology
Neoplasms
therapeutics
Design

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Agricultural and Biological Sciences (miscellaneous)
  • Applied Mathematics
  • Statistics and Probability
  • Public Health, Environmental and Occupational Health

Cite this

Chang, M. N., Therneau, T. M., Wieand, H. S., & Cha, S. S. (1987). Design for group sequential phase II clinical trials. Biometrics, 43(4), 865-874.

Design for group sequential phase II clinical trials. / Chang, M. N.; Therneau, Terry M; Wieand, H. S.; Cha, S. S.

In: Biometrics, Vol. 43, No. 4, 1987, p. 865-874.

Research output: Contribution to journalArticle

Chang, MN, Therneau, TM, Wieand, HS & Cha, SS 1987, 'Design for group sequential phase II clinical trials', Biometrics, vol. 43, no. 4, pp. 865-874.
Chang MN, Therneau TM, Wieand HS, Cha SS. Design for group sequential phase II clinical trials. Biometrics. 1987;43(4):865-874.
Chang, M. N. ; Therneau, Terry M ; Wieand, H. S. ; Cha, S. S. / Design for group sequential phase II clinical trials. In: Biometrics. 1987 ; Vol. 43, No. 4. pp. 865-874.
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