Five-year change in statistical designs of phase II trials published in leading cancer journals

European Journal of Cancer

Volumn 40, Issue 8, 2004, Pages 1244-1249

  Thezenas, S ^a   Duffour, J ^a   Culine, S ^a   Kramar, A ^a  

^a CENTRE VAL D AURELLE   (France)

Author keywords

Leading cancer journals; Statistical design reporting: Phase II clinical trials

Indexed keywords

ARTICLE; CANCER; HUMAN; MEDICAL LITERATURE; PRIORITY JOURNAL; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL PARAMETERS;

CLINICAL TRIALS, PHASE II; HUMANS; NEOPLASMS; PERIODICALS; STATISTICS;

EID: 1942520219     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2004.01.008     Document Type: Article

References (12)

1. Gehan E.A. The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. J. Chronic. Dis. 13:1961;346-353.
2. Fleming T.R. One-sample multiple testing procedures for phase II clinical trials. Biometrics. 38:1982;143-151.
3. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin. Trials. 10:1989;1-10.
4. Ensign L.G., Gehan E.A., Kamen D.S.et al. An optimal three-stage design for phase II clinical trials. Stat. Med. 15:1994;1727-1736.
5. Bryant J., Day R. Incorporating toxicity considerations into the design of two stage phase II clinical trials. Biometrics. 51:1995;1372-1383.
6. Mariani L., Marubini E. Content and quality of currently published phase II cancer trials. Journal of Clinical Oncology. 8:2000;429-436.
7. Vabre F, Kramar A. Evaluation du nombre de sujets nécessaires dans la planification des essais de phase II en cancérologie- Revue de la littérature. Eurocancer: John Libbey Eurotext, Paris III.3.4; 1996; 408.
8. Lee Y.J. Phase II trials in cancer - present status and analysis methods. Drugs Exp. Clin. Res. 12:1986;57-71.
9. Kramar A., Potvin D., Hill C. Multistage designs for phase II clinical trials. statistical issues in cancer research Br. J. Cancer. 74:1996;1317-1320.
10. Simon R., Wittes R.E. Methodology guidelines for phase II cancer clinical trials. Cancer Treat. Rep. 69:1985;1-3.
11. ICH9. Statistical principals for clinical trials〈CPMP/ICH/363/96. 1998.
12. Dent S., Zee B., Dancey J.et al. Application of new multinomial phase II stopping rule using response and early progression. J. Clin. Oncol. 19:2001;785-791.