A modification of simon's optimal design for phase II trials when the criterion is median sample size

Controlled Clinical Trials

Volumn 20, Issue 6, 1999, Pages 555-566

  Hanfelt, John J ^a   Slack, Rebecca S ^b   Gehan, Edmund A ^b  

^a EMORY UNIVERSITY   (United States)

^b GEORGETOWN UNIVERSITY   (United States)

Author keywords

Clinical trials; Multistage study design

Indexed keywords

DRUG;

CLINICAL TRIAL; DATA ANALYSIS; DRUG RESEARCH; HUMAN; METHODOLOGY; PHASE 2 CLINICAL TRIAL; REVIEW; SAMPLE; STATISTICAL ANALYSIS;

EID: 0033460227     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(99)00028-8     Document Type: Article

References (8)

1. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 10:1989;1-10.
2. Marsoni S., Hoth D., Simon R.et al. Clinical drug development. an analysis of phase II trials, 1970-1985 Cancer Treat Rep. 71:1987;71-80.
3. Ensign L.G., Gehan E.A., Kamen D.S.et al. An optimal three-stage design for phase II clinical trials. Stat Med. 13:1994;1727-1736.
4. Herndon J.E. A design alternative for two-stage, phase II, multicenter cancer clinical trials. Control Clin Trials. 19:1998;440-450.
5. Green S.J., Dahlberg S. Planned versus attained designs in phase II clinical trials. Stat Med. 11:1992;853-862.
6. Chen T.T. Optimal three-stage design for phase II cancer clinical trials. Stat Med. 16:1997;2701-2711.
7. Thall P.F., Simon R. Practical Bayesian guidelines for phase IIB clinical trials. Biometrics. 50:1994;337-349.
8. Mariani L., Marubini E. Design and analysis of phase II cancer trials. a review of statistical methods and guidelines for medical researchers Int Stat Rev. 64:1996;61-88.