Issues in Planning Interim Analyses

Coronary Drug Project Research Group. Practical aspects of decision making in clinical trials: The coronary drug project as a case study. Controlled Clin Trials. 1981;1: 363.

Armitage P McPherson CK Rowe BC . Repeated significance tests on accumulating data. JRSS. 1969;A132: 235–244.

Haybittle JL . Repeated assessment of results in clinical trials in cancer treatment. Br J Radiol. 1971;44: 793.

Peto R Pike MC Armitage P Breslowne Cox DR Howard SV Mantel N McPherson K Peto J Smith PG . Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I Br J Cancer. 1976;34: 585.

Aspirin Myocardial Infarction Study Research Group. A randomized controlled trial of aspirin in persons recovered from myocardial infarction. JAMA. 1980;243: 661.

Armitage P . Sequential medical trials (Second Edition). New York: John Wiley & Sons; 1975.

Pocock SJ . Group sequential methods in the design and analysis of clinical trials. Biometrika. 1977;64: 191.

O'Brien PC Fleming TR . A multiple testing procedure for clinical trials. Biometrics. 1979;35: 549.

DeMets DL Hardy R Friedman LM Lan KKG . Statistical aspects of early termination in the beta-blocker heart attack trial. Controlled Clin Trials. 1984;5: 362.

Pocock SJ . Interim analyses for randomized clinical trials: The group sequential approach. Biometrics. 1982;38: 153.

Tsiatis AA . Repeated significance testing for a general class of statistics used in censored survival analysis. JASA. 1982;77: 855.

Gail MH DeMets DL Slud EV . Simulation studies on increments of the two-sample logrank score tests for survival time data with application to group sequential boundaries. In: Survival analysis. IMS Monograph Series; 1982: 287–301.

DeMets DL Gail MH . Use of logrank tests and group sequential methods at fixed calendar times. Biometrics. 1985;41: 1039.

Lan KKG DeMets DL . Discrete sequential boundaries for clinical trials. Biometrika. 1983;70: 659.

Lan KKG Simon R Halperin M . Stochastically curtailed tests in long-term clinical trials. Commun Stat. 1982;1: 207.

Ware JH Muller JE Braunwald E . The futility index: An approach to the cost-effective termination of randomized clinical trials. Am J Med. 1985;78: 635.

Lan KKG Wittes J . The B-value: A tool for monitoring data. Biometrics. 1988;44: 579.

DeMets DC Lan KKG . An overview of sequential methods and their application in clinical trials. Commun Stat — Theory Methods. 1984;13: 2315.

Geller NL Pocock SJ . Design and analysis of clinical trials with group sequential stopping rules. In: Peace KE , ed. Handbook of biopharmaceutical statistics in human drug development. New York: Marcel Dekker, Inc.; 1987: 489–508.