What is the appropriate role of the trial statistician in preparing and presenting interim findings to an independent Data Monitoring Committee in the U.S. Cancer Cooperative Group Setting?

Statistics in Medicine

Volumn 23, Issue 10, 2004, Pages 1507-1511

  Bryant, John ^a  

^a UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Blinding data; Co operative groups; Data monitoring committees; Data safety monitoring boards; Data safety monitoring committees; DMC; DSMB; DSMC; Group sequential interim policies; Interim analyses; Phase III clinical trials

Indexed keywords

ANALYTICAL ERROR; ARTICLE; CANCER CENTER; CANCER STATISTICS; CLINICAL STUDY; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; MEDICAL SOCIETY; MEDICAL SPECIALIST; MONITORING; OUTCOMES RESEARCH; POLICY; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RESPONSIBILITY; STATISTICAL ANALYSIS; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CLINICAL TRIALS DATA MONITORING COMMITTEES; CLINICAL TRIALS, PHASE III; DATA COLLECTION; DATA INTERPRETATION, STATISTICAL; ETHICS, PROFESSIONAL; FEMALE; HUMANS; NATIONAL INSTITUTES OF HEALTH (U.S.); RESEARCH SUBJECTS; STATISTICS; SURVIVAL ANALYSIS; UNITED STATES;

EID: 2442652724     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1785     Document Type: Article

References (7)

1. NCI Cooperative Group Data Monitoring Policy: http://ctep.cancer.gov
2. Smith MA, Ungerleider RS, Korn EL, Rubinstein L, Simon R. Role of independent data-monitoring committees in randomized clinical trials sponsored by NCI. Journal of Clinical Oncology 1997; 15:2736-2743.
3. FDA Draft Guidance for Clinical Trial Sponsors - On the Establishment and Operation of Clinical Trial Data Monitoring Committees, www.fda.gov/cber/gdlns/clindatmon.htm
4. Ellenberg S, George S, Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership? Statistics in Medicine 2004; 23:1503-1505.
5. Comments of the Group Statisticians of the NCI-Funded Cooperative Groups to FDA Draft Guidance for Clinical Trial Sponsors - 'On the Establishment and Operation of Clinical Trial Data Monitoring Committees'.
6. Early Breast Cancer Trialists' Collaborative Group (EBCTCB) http://www.ctsu.ox.ac.uk/projects/ebctcg.shtml
7. Mamounas EP, Bryant J, Lembersky BC, Fisher B, Atkins JN, Fehrenbacher L, Raich PC, Yothers G, Soran A, Wolmark N. 'Paclitaxel (T) following doxorubicin/cyclophosphamide (AC) as adjuvant therapy for node-positive breast cancer: results from NSABP B-28.' Proceedings of the 39th Annual Meeting of the American Society of Clinical Oncology 2003; 22:4 (abstr 12).