×

Adaptive group sequential designs for clinical trials: combining the advantages of adaptive and of classical group sequential approaches. (English) Zbl 1209.62180

Summary: A general method is presented integrating the concept of adaptive interim analyses into classical group sequential testing. This allows the researcher to represent every group sequential plan as an adaptive trial design and to make design changes during the course of the trial after every interim analysis in the same way as with adaptive designs. The concept of adaptive trial designing is thereby generalized to a large variety of possible sequential plans.

MSC:

62L05 Sequential statistical design
62P10 Applications of statistics to biology and medical sciences; meta analysis
PDFBibTeX XMLCite
Full Text: DOI

References:

[1] Armitage, Repeated significance tests on accumulating data, Journal of the Royal Statistical Society, Series A 132 pp 235– (1969) · doi:10.2307/2343787
[2] Banik, On the power of Fisher’s combination test for two stage sampling in the presence of nuisance parameters, Biometrical Journal 38 pp 25– (1996) · Zbl 0860.62084 · doi:10.1002/bimj.4710380103
[3] Bauer, Multistage testing with adaptive designs (with discussion), Biometrie und Informatik in Medizin und Biologie 20 pp 130– (1989)
[4] Bauer, The choice of sequential boundaries based on the concept of power spending, Biometrie und Informatik in Medizin und Biologie 23 pp 3– (1992)
[5] Bauer, Evaluation of experiments with adaptive interim analyses, Biometrics 50 pp 1029– (1994) · Zbl 0825.62789 · doi:10.2307/2533441
[6] Brittain, Optimization of multistage testing times and critical values in clinical trials, Biometrics 49 pp 763– (1993) · Zbl 0800.62696 · doi:10.2307/2532197
[7] Cui, Modification of sample size in group sequential clinical trials, Biometrics 55 pp 853– (1999) · Zbl 1059.62636 · doi:10.1111/j.0006-341X.1999.00853.x
[8] DeMets, Group sequential methods in clinical trials with a one-sided hypothesis, Biometrika 67 pp 651– (1980) · doi:10.1093/biomet/67.3.651
[9] DeMets, Asymmetric group sequential boundaries for monitoring clinical trials, Biometrika 69 pp 661– (1982) · doi:10.1093/biomet/69.3.661
[10] Fisher, Self-designing clinical trials, Statistics in Medicine 17 pp 1551– (1998) · doi:10.1002/(SICI)1097-0258(19980730)17:14<1551::AID-SIM868>3.0.CO;2-E
[11] Fleming, Designs for group sequential tests, Controlled Clinical Trials 5 pp 348– (1984) · doi:10.1016/S0197-2456(84)80014-8
[12] Lan, Discrete sequential boundaries for clinical trials, Biometrika 70 pp 659– (1983) · Zbl 0543.62059 · doi:10.2307/2336502
[13] Lehmacher, Adaptive sample size calculation in group sequential trials, Biometrics 55 pp 1286– (1999) · Zbl 1059.62671 · doi:10.1111/j.0006-341X.1999.01286.x
[14] Martinez-Martin, Pallidotomy and quality of life in patients with Parkinson’s disease: An early study, Movement Disorders 15 pp 65– (2000) · doi:10.1002/1531-8257(200001)15:1<65::AID-MDS1011>3.0.CO;2-Y
[15] Müller, Optimization of testing times and critical values in sequential equivalence testing, Statistics in Medicine 18 pp 1769– (1999) · doi:10.1002/(SICI)1097-0258(19990730)18:14<1769::AID-SIM213>3.0.CO;2-H
[16] O’Brien, A multiple testing procedure for clinical trials, Biometrics 35 pp 549– (1979) · doi:10.2307/2530245
[17] Pocock, Group sequential methods in the design and analysis of clinical trials, Biometrika 64 pp 191– (1977) · doi:10.1093/biomet/64.2.191
[18] Pocock, Interim analyses for randomized clinical trials: The group sequential approach, Biometrics 38 pp 153– (1982) · doi:10.2307/2530298
[19] Proschan, Designed extension of studies based on conditional power, Biometrics 51 pp 1315– (1995) · Zbl 0875.62506 · doi:10.2307/2533262
[20] Shen, Statistical inference for self-designing clinical trials with a one-sided hypothesis, Biometrics 55 pp 190– (1999) · Zbl 1059.62712 · doi:10.1111/j.0006-341X.1999.00190.x
[21] Tsiatis, Exact confidence intervals following a group sequential test, Biometrics 40 pp 797– (1984) · Zbl 0565.62021 · doi:10.2307/2530924
[22] Wang, Approximately optimal one-parameter boundaries for group sequential trials, Biometrics 43 pp 193– (1987) · Zbl 0609.62120 · doi:10.2307/2531959
[23] Wassmer, A technical note on the power determination for Fisher’s combination test, Biometrical Journal 39 pp 831– (1997) · Zbl 1127.62315 · doi:10.1002/bimj.4710390711
[24] Wassmer, A comparison of two methods for adaptive interim analyses in clinical trials, Biometrics 54 pp 696– (1998) · Zbl 1058.62668 · doi:10.2307/3109775
This reference list is based on information provided by the publisher or from digital mathematics libraries. Its items are heuristically matched to zbMATH identifiers and may contain data conversion errors. In some cases that data have been complemented/enhanced by data from zbMATH Open. This attempts to reflect the references listed in the original paper as accurately as possible without claiming completeness or a perfect matching.