New statistical strategy for monitoring safety and efficacy in single-arm clinical trials

Journal of Clinical Oncology

Volumn 14, Issue 1, 1996, Pages 296-303

  Thall, P F ^a   Simon, R M ^a   Estey, E H ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOSPORIN A; CYTARABINE; IDARUBICIN;

ACUTE MYELOBLASTIC LEUKEMIA; ARTICLE; BAYES THEOREM; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; COMPUTER PROGRAM; DATA ANALYSIS; DRUG EFFICACY; DRUG MONITORING; DRUG SAFETY; HUMAN; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; TOXICITY TESTING; TREATMENT OUTCOME;

EID: 0030060408     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1996.14.1.296     Document Type: Article

References (9)

1. Thall PF, Simon R, Estey EH: Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes. Stat Med 14:357-379, 1995
2. Gehan EA: The determination of the number of patients required in a follow-up trial of a new chemotherapeutic agent. J Chronic Dis 13:346-353, 1961
3. Fleming TR: One sample multiple testing procedure for phase II clinical trials. Biometrics 38:143-151, 1982
4. Simon R: Optimal two-stage designs for phase II clinical trials. Controlled Clin Trials 10:1-10, 1989
5. Keating M, Smith T, McCredie K, et al: A four-year experience with anthracycline, cytosine arabinoside, vincristine, and prednisone in 325 adults with adult leukemia. Cancer 47:2779-2788, 1981
6. Keating M, McCredie K, Benjamin R, et al: Treatment of patients over 50 years of age with acute myelogenous leukemia with a combination of rubidazone, and cytosine arabinoside, vincristine, and prednisone. Blood 58:584-591, 1981
7. Estey E, Keating M, McCredie K, et al: Causes of initial remission induction failure in acute myelogenous leukemia. Blood 60:309-315, 1982
8. Lee PM: Bayesian Statistics: An Introduction. New York, NY, Oxford University Press, 1989
9. Thall PF, Simon R: Incorporating historical control data in planning phase II clinical trials. Stat Med 9:215-228, 1990