Data monitoring committees for pragmatic clinical trials

Clinical Trials

Volumn 12, Issue 5, 2015, Pages 530-536

  Ellenberg, Susan S ^a   Culbertson, Richard ^b   Gillen, Daniel L ^c   Goodman, Steven ^d   Schrandt, Suzanne ^e   Zirkle, Maryan ^e  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER   (United States)

^c Ringgold Standard Institution Informatics   (United States)

^d STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e PATIENT CENTERED OUTCOMES RESEARCH INSTITUTE   (United States)

Author keywords

biostatistics; cluster randomized trials; data monitoring committee; early termination; Pragmatic clinical trials

Indexed keywords

ACCURACY; ANALYSIS; ASSESSMENT OF HUMANS; CLINICAL PRACTICE; CLUSTER DESIGN; DATA MONITORING COMMITTEE; DATA QUALITY; DECENTRALIZED ANALYSIS; DISEASE COURSE; EARLY TERMINATION; ELECTRONIC MEDICAL RECORD; FOLLOW UP; HUMAN; INTERIM MONITORING; MEDICAL INFORMATICS; METHODOLOGY; MONITORING; ORGANIZATION; OUTCOME ASSESSMENT; PATIENT ELIGIBILITY; PATIENT SAFETY; PATIENT SELECTION; PRAGMATIC EXPLANATORY CONTINUUM INDICATOR SUMMARY TOOL; PRIORITY JOURNAL; PROCESS OPTIMIZATION; PROTOCOL COMPLIANCE; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REFERENCE VALUE; REVIEW; STUDY DESIGN; CLINICAL TRIAL (TOPIC); ETHICS; INFORMATION DISSEMINATION; INFORMATION PROCESSING; LEGISLATION AND JURISPRUDENCE; PROFESSIONAL STANDARD; STANDARDS; UNITED STATES;

CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS DATA MONITORING COMMITTEES; DATA COLLECTION; HUMANS; INFORMATION DISSEMINATION; RESEARCH DESIGN; UNITED STATES;

EID: 84942935701     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774515597697     Document Type: Review

References (40)

1. Ellenberg SS, Fleming TR, DeMets DL., Data monitoring committees in clinical trials: a practical perspective. Chichester: John Wiley & Sons, 2002.
2. Herson J., Data and safety monitoring committees in clinical trials. Boca Raton, FL: Chapman & Hall/CRC, 2009.
3. DeMets DL, Furberg CD, Friedman LM, (eds). Data monitoring in clinical trials: a case studies approach. New York: Springer, 2006.
4. Hess CN, Roe MT, Gibson CM, et al. Independent data monitoring committees: preparing a path for the future. Am Heart J 2014; 168: 135-141.
5. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol 2009; 62: 464-475.
6. Ellenberg S, Fernandes RM, Saloojee H, et al. Standard 3: data monitoring committees. Pediatrics 2012; 129 (Suppl. 3): S132-S137.
7. Smith MA, Ungerleider RS, Korn EL, et al. Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute. J Clin Oncol 1997; 15: 2736-2743.
8. Schwartz D, Lellouch J., Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis 1967; 20: 637-648.
9. ISIS-1 (First International Study of Infarct Survival) Collaborative Group. Mechanisms for the early mortality reduction produced by beta-blockade started early in acute myocardial infarction: ISIS-1. Lancet 1988; 1: 921-923.
10. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17 187 cases of suspected acute myocardial infarction: ISIS-2. Lancet 1988; 2: 349-360.
11. ISIS-3 (Third International Study of Infarct Survival) Collaborative Group. ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41 299 cases of suspected acute myocardial infarction. Lancet 1992; 339: 753-770.
12. ISIS-4 (Fourth International Study of Infarct Survival) Collaborative Group. ISIS-4: a randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58 050 patients with suspected acute myocardial infarction. Lancet 1995; 345: 669-685.
13. Fröbert O, Lagerqvist B, Gudnason T, et al. Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale. Am Heart J 2010; 160: 1042-1048.
14. The CREATE-ECLA Trial Group Investigators. Effect of glucose-insulin-potassium infusion on mortality in patients with acute ST-segment elevation myocardial infarction: the CREATE-ECLA randomized controlled trial. JAMA 2005; 293: 437-446.
15. Tunis SR, Stryer DB, Clancy CM., Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003; 290: 1624-1632.
16. Fleming TR, Hennekens CH, Pfeffer MA, et al. Enhancing trial integrity by protecting the independence of data monitoring committees in clinical trials. J Biopharm Stat 2014; 24: 968-975.
17. Fleming TR., Protecting the confidentiality of interim data: addressing current challenges. Clin Trials 2015; 12: 5-11.
18. Nissen SE., Commentary: confidentiality of interim trial data-the emerging crisis. Clin Trials 2015; 12: 15-17.
19. Ahmed S, Berzon RA, Revicki DA, et al. The use of patient-reported outcomes (PRO) within comparative effectiveness research: implications for clinical practice and health care policy. Med Care 2012; 50: 1060-1070.
20. Robiner WN., Enhancing adherence in clinical research. Contemp Clin Trials 2005; 26: 59-77.
21. Peto R, Baigent C., Trials: the next 50 years. Large scale randomised evidence of moderate benefits. BMJ 1998; 317: 1170-1171.
22. The Digitalis Investigators. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med 1997; 336: 525-533.
23. Curtis LH, Weiner MG, Boudreau DM, et al. Design considerations, architecture, and use of the Mini-Sentinel distributed data system. Pharmacoepidemiol Drug Saf 2012; 21 (Suppl. 1): 23-31.
24. Brown JS, Kahn M, Toh S., Data quality assessment for comparative effectiveness research in distributed data networks. Med Care 2013; 51: S22-S29.
25. Donner A, Klar N., Design and analysis of cluster randomization trials in health research. New York: Wiley, 2000.
26. Donner A, Klar N., Pitfalls of and controversies in cluster randomization trials. Am J Public Health 2004; 94: 416-422.
27. Campbell MK, Grimshaw JM, Elbourne DR., Intracluster correlation coefficients in cluster randomized trials: empirical insights into how should they be reported. BMC Med Res Meth 2004; 4: 9.
28. Califf RM, Sugarman J,. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials, 2015; 12: 436-441.
29. Patient-Centered Outcomes Research Institute. PCORI methodology report., http://www.pcori.org/assets/2013/11/PCORI-Methodology-Report-Appendix-A.pdf (2013,. accessed 21 January 2015).
30. Cashman SB, Adeky S, Allen AJ 3rd, et al. The power and the promise: working with communities to analyze data, interpret findings, and get to outcomes. Am J Public Health 2008; 98: 1407-1417.
31. Flynn KE, Kramer JM, Dombeck CB, et al. Participants perspectives on safety monitoring in clinical trials. Clin Trials 2013; 10: 552-559.
32. Mikesell L, Bromley E, Khodyakov D., Ethical community-engaged research: a literature review. Am J Public Health 2013; 103: e7-e14.
33. McDonagh JE, Bateman B., "Nothing about us without us": considerations for research involving young people. Arch Dis Child Educ Pract Ed 2012; 97: 55-60.
34. Patient-Centered Outcomes Research Institute. PCORI engagement rubric with table., http://www.pcori.org/sites/default/files/PCORI-Engagement-Rubric-with-Table.pdf (2015,. accessed 21 January 2015).
35. Teunissen T, Visse M, de Boer P, et al. Patient issues in health research and quality of care: an inventory and data synthesis. Health Expect 2013; 16: 308-322.
36. Godlew BJ, Furlong P., Transparency as a means to increase clinical trial enrollment. Drug Inform J 2010; 44: 265-270.
37. Strauss RP, Sengupta S, Quinn SC, et al. The role of community advisory boards: involving communities in the informed consent process. Am J Public Health 2001; 91: 1938-1943.
38. Landy DC, Brinich MA, Colten ME, et al. How disease advocacy organizations participate in clinical research: a survey of genetic organizations. Genet Med 2012; 14: 223-228.
39. Terry SF, Terry PF, Rauen KA, et al. Advocacy groups as research organizations: the PXE International example. Nat Rev Genet 2007; 8: 157-164.
40. Richards T., The rise and reach of expert patients. In: BMJ blog, 2014, http://blogs.bmj.com/bmj/2014/01/17/tessa-richards-the-rise-and-reach-of-expert-patients/ (. accessed 21 January 2015).