Multi-arm clinical trials of new agents: Some design considerations

Clinical Cancer Research

Volumn 14, Issue 14, 2008, Pages 4368-4371

  Freidlin, Boris ^a   Korn, Edward L ^a   Gray, Robert ^b   Martin, Alison ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; E 2805; PLACEBO; SORAFENIB; SUNITINIB; UNCLASSIFIED DRUG;

ARTICLE; CANCER PATIENT; CANCER RECURRENCE; CANCER RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG INDUSTRY; HUMAN; KIDNEY CANCER; LOGISTIC REGRESSION ANALYSIS; NEPHRECTOMY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS; METHODOLOGY; NEOPLASM; PHASE 3 CLINICAL TRIAL; REVIEW;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 51649086407     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-08-0325     Document Type: Article

References (25)

1. Roberts TG, Jr., Lynch TJ, Jr., Chabner BA. The phase III trial in the era of targeted therapy: unraveling the "go or no go" decision. J Clin Oncol 2003;21:3683-95.
2. Benson AB III, Pregler JP, Bean JA, et al. Oncologists' reluctance to accrue patients onto clinical trials: an Illinois Cancer Center study. J Clin Oncol 1991;9: 2067-75.
3. Avins AL. Can unequal be more fair? Ethics, subject allocation, and randomised clinical trials. J Med Ethics 1998;24:401-8.
4. Jenkins V, Fallowfield L Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer 2000;82:1783-8.
5. Eisen T. Adjuvant therapy in renal cell carcinoma: where are we? Eur Urol Suppl 2007;6:492-8.
6. Fleiss JL. The design and analysis of clinical experiments. New York: Wiley; 1986. p. 96.
7. Godfrey K. Statistics in practice. Comparing the means of several groups. N Engl J Med 1985;313: 1450-6.
8. Bauer P. Multiple testing in clinical trials. Stat Med 1991;10:871-89.
9. Proschan MA, Folmann DA. Multiple comparisons in a single experiment versus separate experiments: why do we feel differently? Am Stat 1995;49:144-9.
10. Dunnett CW. A multiple comparisons procedure for comparing several treatments with a control. J Am Stat Assoc 1955;50:1096-1121.
11. Holm S. A simple sequentially rejective multiple test procedure. Scand J Stat 1979;6:65-70.
12. Bristol DR. Designing clinical trials for two-sided multiple comparisons with a control. Control Clin Trials 1989;10:142-52.
13. Hughes MD. Multiplicity in clinical trials. In: Kotz S, Johnson NL, Read CB, editors. Encyclopedia of biostatistics. New York: Wiley; 1998.
14. Proschan MA, Waclawiw MA. Practical guidelines for multiplicity adjustment in clinical trials. Control Clin Trials 2000;21:527-39.
15. Fossella F, Pereira JR, von Pawel J, et al. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol 2003;21: 3016-24.
16. Perez EA, Suman VJ, Davidson NE, et al. Effect of doxorubicin plus cyclophosphamide on left ventricular ejection fraction in patients with breast cancer in the North Central Cancer Treatment Group N9831 Intergroup Adjuvant Trial. J Clin Oncol 2004;22: 3700-4.
17. Rosen LS, Gordon D, Tchekmedyian S, et al. Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial - the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. J Clin Oncol 2003;21:3150-7.
18. EMEA CPMP. Points to consider on multiplicity issues in clinical trials. http://www.emea.europa.eu/pdfs/human/ewp/090899en.pdf.
19. Cook RJ, Farewell VT Multiplicity considerations in the design and analysis of clinical trials. J R Stat Soc [SerA] 1996;159:93-110.
20. Miller R. Simultaneous statistical inference. New York: Springer-Verlag; 1981. p. 26.
21. Dixon DO, Pennello G. Comment on: Practical guidelines for multiplicity adjustment in clinical trials. Control ClinTrials 2001;22:548-52.
22. Proschan MA, Waclawiw MA. Authors reply: Practical guidelines for multiplicity adjustment in clinical trials. Control ClinTrials 2001;22:548-52.
23. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35:549-56.
24. Vermorken JB, Parmar MK, Brady MF, et al. Clinical trials in ovarian carcinoma: study methodology. Ann Oncol 2005;16 Suppl 8:20-9.
25. George SL. Reducing patient eligibility criteria in cancer clinical trials. J Clin Oncol 1996;14:1364-70.