Experiences and challenges in data monitoring for clinical trials within an international tropical disease research network

Clinical Trials

Volumn 3, Issue 5, 2006, Pages 469-477

  Chen Mok, Mario ^a,c   VanRaden, J M ^b   Higgs, S E ^b   Dominik, R ^a  

^a FAMILY HEALTH INTERNATIONAL   (United States)

^b NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^c Family Health International ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; EDUCATION; HUMAN; INTERNATIONAL COOPERATION; NONBIOLOGICAL MODEL; ORGANIZATION AND MANAGEMENT; PERSONNEL; PROFESSIONAL STANDARD; PROGRAM DEVELOPMENT; STANDARD; SYSTEM ANALYSIS; TROPICAL MEDICINE;

CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS DATA MONITORING COMMITTEES; HUMANS; INTERNATIONAL COOPERATION; MODELS, ORGANIZATIONAL; OPERATIONS RESEARCH; PROGRAM DEVELOPMENT; RESEARCH PERSONNEL; TROPICAL MEDICINE;

EID: 41249096162     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774506070710     Document Type: Article

References (32)

1. Heart Special Project Committee. Organization, review and administration of cooperative studies: A report from the Health Special Project Committee to the National Advisory Heat Council. Control Clin Trials 1988; 9: 137-148.
2. National Institutes of Health. NIH policy for data and safety monitoring. 10 June 1998; available at http://grants.nih.gov/grants/ guide/notice-files/not98084.html. (accessed 12 August 2005).
3. National Institutes of Health. Further guidance on a data and safety monitoring for phase I and phase II trials. 5 June 2000; available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html (accessed 12 August 2005).
4. Hawkins BS. Data monitoring committees for multicenter clinical trials sponsored by the National Institutes of Health. I. Roles and membership of data monitoring committees for trials sponsored by the National Eye Institute. Control Clin Trials 1991; 12: 424-437.
5. Geller NL, Stylianou M. Practical issues in data monitoring of clinical trials: Summary of responses to a questionnaire at NIH. Stat Med 1993; 12: 543-551; discussion 553-553.
6. George SL. A survey of monitoring practices in cancer clinical trials. Stat Med 1993; 12: 435-450.
7. Walters L. Data monitoring committees: The moral case for maximum feasible independence. Stat Med 1993; 12: 575-580; discussion 581-568.
8. Fleming TR, Ellenberg S, DeMets DL. Monitoring clinical trials: Issues and controversies regarding confidentiality. Stat Med 2002; 21: 2843-2851.
9. Slutsky AS, Lavery JV. Data safety and monitoring boards. N Engl J Med 2004; 350: 1143-1147.
10. Wells RJ. Data safety and monitoring boards. N Engl J Med 2004; 350: 2423-2423; author reply 2423-2423.
11. Ellenberg SS, Monitoring data on data monitoring. Clinical Trials 2004; 1: 6-18.
12. Sydes MR, Spiegelhalter DJ, Altman DG et al. Systematic qualitative review of the literature on data monitoring committees for randomised controlled trials. Clinical Trials 2004; 1: 60-79.
13. DAMOCLES Study Group, NHS Health Technology Assessment Programme. A proposed charter for clinical trial data monitoring committees: Helping them to do their job well. Lancet 2005; 365: 711-722.
14. Grant AM, Altman DG, Babiker AB et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess 2005; 9: 1-238.
15. Ellenberg SS, Fleming TR, DeMets DL. Data monitoring committees in clinical trials. John Wiley & Sons Ltd, 2002.
16. U.S. Food and Drug Administration. Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees. March 2006; available at http://www.fda.gov/cber/gdlns/ clintrialdmc.pdf (accessed 21 April 2006).
17. DeMets DL, Califf RM, Dixon D et al. Issues in regulatory guidelines for data monitoring committees. Clinical Trials 2004; 1: 162-169.
18. DeMets DL, Fleming TR, Whitley RJ et al. The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. Control Clin Trials 1995; 16: 408-421.
19. Division of Microbiology & Infectious Diseases, National Institutes of Health. Data and safety monitoring board (DSMB) guidelines. Available at http://www.niaid.nih.gov/dmid/clinresearch/dsm.htm (accessed 12 August 2005).
20. Division of Microbiology & Infectious Diseases, NIoH. Clinical Terms of Award. 1 February 2005; available at http://www.niaid.nih.gov/ncn/pdf/ clinterm.pdf (accessed 8 May 2006).
21. Division of Microbiology & Infectious Diseases, National Institutes of Health. Independent safety monitor (ISM) guidelines. Available at http://www.niaid.nih.gov/dmid/clinresearch/ism.htm (accessed 12 August 2005).
22. Division of Microbiology & Infectious Diseases, National Institutes of Health. Safety monitoring committee (SMC) guidelines. Available at http://www.niaid.nih.gov/dmid/clinresearch/smc.htm (accessed 12 August 2005).
23. Meinert CL. Masked monitoring in clinical trials - blind stupidity? N Engl J Med 1998; 338: 1381-1382.
24. Lachin JM. Conflicts of interest in data monitoring of industry versus publicly financed clinical trials. Stat Med 2004; 23: 1519-1521.
25. D'Agostino RB, Sr. The statistician and the data monitoring committee. Stat Med 2004; 23: 1501-1502.
26. Ellenberg SS, George SL. Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership? Stat Med 2004; 23: 1503-1505.
27. DeMets DL, Fleming TR. The independent statistician for data monitoring committees. Stat Med 2004; 23: 1513-1517.
28. Pocock SJ. A major trial needs three statisticians: Why, how and who? Stat Med 2004; 23: 1535-1539.
29. Snapinn S, Cook T, Shapiro D, Snavely D. The role of the unblinded sponsor statistician. Stat Med 2004; 23: 1531-1533.
30. Siegel JP, O'Neill RT, Temple R, Campbell G, Foulkes MA. Independence of the statistician who analyses unblinded data. Stat Med 2004; 23: 1527-1529.
31. Wittes J. Playing safe and preserving integrity: Making the FDA model work. Stat Med 2004; 23: 1523-1525.
32. Bryant J. 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? Stat Med 2004; 23: 1507-1511.