Data monitoring committees and interim monitoring guidelines

Controlled Clinical Trials

Volumn 20, Issue 5, 1999, Pages 395-407

  Freidlin, Boris ^a   Korn, Edward L ^a   George, Stephen L ^b  

^a NATIONAL CANCER INSTITUTE   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Bayesian methods; Clinical trials; Group sequential trials; Interim analysis; Stochastic curtailment

Indexed keywords

ARTICLE; BAYES THEOREM; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; HYPOTHESIS; MONITORING; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; SAFETY; STATISTICS; THERAPY;

BAYES THEOREM; DATA INTERPRETATION, STATISTICAL; GUIDELINES; HUMANS; PROFESSIONAL STAFF COMMITTEES; RANDOMIZED CONTROLLED TRIALS;

EID: 0032863539     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(99)00017-3     Document Type: Article

References (29)

1. Simon R. Some practical aspects of the interim monitoring of clinical trials. Stat Med. 13:1994;1401-1409.
2. Armitage P., McPherson C.K., Rowe B.C. Repeated significance tests on accumulating data. J Roy Stat Soc. A132:1969;235-244.
3. Armitage P. Sequential Medical Trials. 2nd ed:1975;Wiley, New York.
4. Whitehead J. Sequential methods based on the boundaries approach for the clinical comparison of survival times. Stat Med. 13:1994;1357-1368.
5. Pocock S.J. Group sequential methods in the design and analysis of clinical trials. Biometrika. 64:1977;191-200.
6. O'Brien P.C., Fleming T.R. A multiple testing procedure for clinical trials. Biometrics. 35:1979;549-556.
7. Ellenberg S.S., Eisenberger M.A. An efficient design for phase III studies of combination chemotherapies. Cancer Treat Rep. 69:1985;1147-1152.
8. Lan K.K.G., DeMets D.L. Discrete sequential boundaries for clinical trials. Biometrika. 70:1983;659-663.
9. Lan K.K.G., Simon R., Halperin M. Stochastically curtailed tests in long-term clinical trials. Sequential Analysis. 1:1982;207-219.
10. Jennison C., Turnbull B.W. Repeated confidence intervals for group sequential clinical trials. Controlled Clin Trials. 5:1984;33-45.
11. Freedman L.S., Spiegelhalter D.J., Parmar M.K.B. The what, why and how of Bayesian clinical trials monitoring. Stat Med. 13:1994;1371-1383.
12. Korn E.L., Simon R. Data monitoring committees and problems of lower-than-expected accrual or event rates. Controlled Clin Trials. 17:1996;526-535.
13. Smith M.A., Ungerleider R.S., Korn E.L.et al. Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute. J Clin Oncol. 15:1997;2736-2743.
14. Canner P.L. Monitoring long-term clinical trials for beneficial and adverse treatment effects. Communications in Statistics, Theory and Methods. 13:1984;2369-2394.
15. McPherson K. On choosing the number of interim analyses in clinical trials. Stat Med. 1:1982;25-36.
16. Pocock S.J. Interim analyses for randomized clinical trials. the group sequential approach Biometrics. 38:1982;153-162.
17. Fleming T.R., Harrington D.P., O'Brien P.C. Designs for group sequential tests. Controlled Clin Trials. 5:1984;348-361.
18. Haybittle J.L. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol. 44:1971;793-797.
19. Peto R., Pike M.C., Armitage P.et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. introduction Br J Cancer. 34:1976;585-612.
20. Reboussin DM, DeMets DL, Kim K, et al. Programs for computing group sequential boundaries using the Lan-DeMets method. Technical Report, Department of Statistics, University of Wisconsin, 1996.
21. Spiegelhatler D.J., Freedman L.S., Blackburn P.R. Monitoring clinical trials. conditional or predictive power? Controlled Clin Trials. 7:1986;8-17.
22. Brunier H, Whitehead J. PEST 3.0 Operating Manual, University of Reading, U.K. 1993.
23. Tan M., Xiong X., Kutner M.H. Clinical trial designs based on sequential conditional probability ratio tests and reverse stochastic curtailing. Biometrics. 54:1998;682-695.
24. Lan K.K.G., DeMets D.L. Group sequential procedures. calendar versus information time Stat Med. 8:1989;1191-1198.
25. Canner P.L. Monitoring treatment differences in long-term clinical trials. Biometrics. 33:1977;603-615.
26. Falissard B., Lellouch J. A new procedure for group sequential analysis in clinical trials. Biometrics. 48:1992;373-388.
27. Henderson I.C., Berry D., Demetri G.et al. Improved disease-free and overall survival from the addition of sequential paclitaxel but not from the escalation of doxirubicin dose level in the adjuvant chemotherapy of patients with node-positive primary breast cancer. ASCO Proceedings. 17:1998;101a.
28. Sylvester R., Bartelink H., Rubens R. A reversal of fortune. practical problems in the monitoring and interpretation of an EORTC breast cancer trial Stat Med. 13:1994;1329-1335.
29. DeMets D.L. Stopping guidelines vs. stopping rules. a practitioner's point of view Communications in Statistics, Theory and Methods. 13:1984;2395-2417.