Application of the triangular test to phase II cancer clinical trials.

Phase II cancer clinical trials are primarily designed to determine whether the response rate p to the treatment under study is greater than a specified value p0, that is to test the null hypothesis H0: p less than or equal to p0 against an alternative hypothesis H1 : p greater than p0 specified by p = p1. As an alternative to the single and multistage procedures and to Wald's continuous sequential probability ratio test (SPRT), we applied the group sequential methods proposed by Jones and Whitehead, namely the triangular test (TT) and the discrete SPRT, to the comparison of p with p0, and we expressed H0 and H1 in terms of the log odds-ratio statistic log [p(1 - p0)/p0(1 - p)]. A stimulation study showed that both the TT and the discrete SPRT had type I error and power close to the nominal values, and they compared favourably with multistage methods in terms of the average sample size.

[1]  S. Pocock.  Group sequential methods in the design and analysis of clinical trials , 1977 .

[2]  J Whitehead,et al.  Group sequential clinical trials with triangular continuation regions. , 1983, Biometrics.

[3]  J. Whitehead,et al.  The analysis of sequential clinical trials , 1979 .

[4]  D. Jones,et al.  The design of a sequential clinical trial for the comparison of two lung cancer treatments. , 1982, Statistics in medicine.

[5]  R. Simon,et al.  Optimal two-stage designs for phase II clinical trials. , 1989, Controlled clinical trials.

[6]  Richard Sylvester.  A bayesian approach to the design of phase II clinical trials. , 1988 .

[7]  T. W. Anderson.  A MODIFICATION OF THE SEQUENTIAL PROBABILITY RATIO TEST TO REDUCE THE SAMPLE SIZE , 1960 .

[8]  E. Gehan,et al.  The determinatio of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. , 1961, Journal of chronic diseases.

[9]  Sylvester Rj,et al.  Design of phase II clinical trials in cancer using decision theory. , 1980 .

[10]  T R Fleming,et al.  One-sample multiple testing procedure for phase II clinical trials. , 1982, Biometrics.

[11]  D J Schaid,et al.  A design for phase II testing of anticancer agents within a phase III clinical trial. , 1988, Controlled clinical trials.

[12]  S S Ellenberg,et al.  Randomized phase II clinical trials. , 1985, Cancer treatment reports.

[13]  J. Herson,et al.  Predictive probability early termination plans for phase II clinical trials. , 1979, Biometrics.

[14]  G. Elfring,et al.  Multiple-stage procedures for drug screening. , 1973, Biometrics.

[15]  John Whitehead,et al.  Sequential forms of the log rank and modified Wilcoxon tests for censored data , 1979 .

[16]  R Sylvester,et al.  A decision theory approach to phase II clinical trials. , 1977, Biomedicine / [publiee pour l'A.A.I.C.I.G.].

[17]  J Whitehead,et al.  Designing phase II studies in the context of a programme of clinical research. , 1985, Biometrics.

[18]  J Whitehead,et al.  Sample sizes for phase II and phase III clinical trials: an integrated approach. , 1986, Statistics in medicine.

[19]  A. Tsiatis,et al.  Approximately optimal one-parameter boundaries for group sequential trials. , 1987, Biometrics.

[20]  J. Benichou,et al.  A simulation study of three sequential methods for the comparison of two treatment groups when the response criterion is censored. , 1986, Statistics in medicine.

[21]  R. Simon,et al.  Two-stage plans for patient accrual in phase II cancer clinical trials. , 1979, Cancer treatment reports.

[22]  P. O'Brien,et al.  A multiple testing procedure for clinical trials. , 1979, Biometrics.

[23]  S G Hilsenbeck.  Early termination of a phase II clinical trial. , 1988, Controlled clinical trials.

[24]  D. Siegmund.  Corrected diffusion approximations in certain random walk problems , 1979, Advances in Applied Probability.