Gatekeepers for pragmatic clinical trials

Clinical Trials

Volumn 12, Issue 5, 2015, Pages 442-448

  Whicher, Danielle M ^a   Miller, Jennifer E ^b,c   Dunham, Kelly M ^a   Joffe, Steven ^d  

^a Outcomes Research Institute   (United States)

^b DUKE UNIVERSITY   (United States)

^c HARVARD UNIVERSITY   (United States)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

comparative effectiveness research; deliberative democracy; Gatekeeper; pragmatic clinical trial; research ethics

Indexed keywords

ARTICLE; CLINICAL STUDY; DECISION MAKING; FUNDING; HEALTH CARE ORGANIZATION; HEALTH CARE SYSTEM; HEALTH PROGRAM; HUMAN; ORGANIZATIONAL DEVELOPMENT; PATIENT ADVOCACY; PHYSICIAN ATTITUDE; PLANNING; PRIORITY JOURNAL; PROCESS DEVELOPMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; RESEARCH PRIORITY; RESOURCE ALLOCATION; STUDY DESIGN; CLINICAL TRIAL (TOPIC); ETHICS; MEDICAL RESEARCH; METHODOLOGY; STANDARDS; UNITED STATES;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; DECISION MAKING; HUMANS; RESEARCH DESIGN; UNITED STATES;

EID: 84942844257     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774515597699     Document Type: Article

References (39)

1. Califf RM, Sugarman J,. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials, 2015; 12: 436-441.
2. Mullins CD, Whicher D, Reese ES, et al. Generating evidence for comparative effectiveness research using more pragmatic randomized controlled trials. Pharmacoeconomics 2010; 28: 969-976.
3. 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.
4. 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.
5. Institute of Medicine. The learning healthcare system: workshop summary., http://www.iom.edu/Reports/2007/The-Learning-Healthcare-System-Workshop-Summary.aspx (2007,. accessed 22 January 2015).
6. National Institutes of Health. NIH Health Care Systems Research Collaboratory., https://www.nihcollaboratory.org (. accessed 24 November 2014).
7. National Patient-Centered Clinical Research Network (PCORnet), http://www.pcornet.org (. accessed 24 November 2014).
8. Patient-Centered Outcomes Research Institute (PCORI). Funding opportunities: large pragmatic studies to evaluate patient-centered outcomes-spring 2015 cycle., http://www.pcori.org/funding-opportunities/announcement/large-pragmatic-studies-evaluate-patient-centered-outcomes-spring (. accessed 22 July 2015).
9. Chalkidou K, Tunis S, Whicher D, et al. The role for pragmatic randomized controlled trials (pRCTs) in comparative effectiveness research. Clin Trials 2012; 9: 436-446.
10. Patterson S, Mairs H, Borschmann R., Successful recruitment to trials: a phased approach to opening gates and building bridges. BMC Med Res Methodol 2011; 11: 73.
11. Weijer C, Grimshaw JM, Eccles MP, et al. The Ottawa Statement on the ethical design and conduct of cluster randomized trials. PLoS Med 2012; 9: e1001346.
12. Weijer C, Grimshaw JM, Taljaard M, et al. Ethical issues posed by cluster randomized trials in health research. Trials 2011; 12: 100.
13. Gallo A, Weijer C, White A, et al. What is the role and authority of gatekeepers in cluster randomized trials in health research? Trials 2012; 13: 116.
14. Taljaard M, Weijer C, Grimshaw JM, et al. The Ottawa Statement on the ethical design and conduct of cluster randomised trials: précis for researchers and research ethics committees. BMJ 2013; 346: f2838.
15. Newington L, Metcalfe A., Researchers and clinicians perceptions of recruiting participants to clinical research: a thematic meta-synthesis. J Clin Med Res 2014; 6: 162-172.
16. Fletcher B, Gheorghe A, Moore D, et al. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open 2012; 2: e000496.
17. Donovan JL, Paramasivan S, de Salis I, et al. Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials. Trials 2014; 15: 5.
18. Daniels N., Just health: meeting health needs fairly. New York: Cambridge University Press, 2007.
19. Gutmann A, Thompson D., Deliberating about bioethics. Hastings Cent Rep 1997; 27: 38-41.
20. National Institutes of Health. New NIH research awards to address multiple chronic conditions., http://www.nih.gov/news/health/aug2014/nccam-20.htm (2014,. accessed 15 December 2014).
21. Buesching DP, Luce BR, Berger ML., The role of private industry in pragmatic comparative effectiveness trials. J Comp Eff Res 2012; 1: 147-156.
22. The Government in the Sunshine Act. 5 U.S.C. §552b.
23. Federal Advisory Committee Act Amendments. 5 U.S.C. app.
24. Patient-Centered Outcomes Research Institute. Merit review process., http://www.pcori.org/content/merit-review-process (2014,. accessed 15 December 2014).
25. National Institutes of Health. Grants & funding: peer review process., http://grants.nih.gov/grants/peer-review-process.htm (. accessed 15 December 2014).
26. Moses H III, Matheson DH, Cairns-Smith S, et al. The anatomy of medical research: US and international comparisons. JAMA 2015; 313: 174-189.
27. Nathan DM, Buse JB, Kahn SE, et al. Rationale and design of the glycemia reduction approaches in diabetes: a comparative effectiveness study (GRADE). Diabetes Care 2013; 36: 2254-2261.
28. Pearson SD, Miller FG, Emanuel EJ., Medicares requirement for research participation as a condition of coverage: is it ethical? JAMA 2006; 296: 988-991.
29. Ratner J, Mullins D, Buesching DP, et al. Pragmatic clinical trials: U.S. payers views on their value. Am J Manag Care 2013; 19: e158-e165.
30. Commonwealth Fund Task Force on Academic Health Centers. From bench to bedside: preserving the research mission of academic health centers., http://www.commonwealthfund.org/usr-doc/AHC-cwf-bench-312.pdf (1999,. accessed 27 April 2015).
31. Britt R., Higher education R&D expenditures resume slow growth in FY 2013. National Center for Science and Engineering Statistics InfoBrief, report no. NSF 15-314, 4 2015. Arlington, VA: National Science Foundation.
32. Fleurence R, Rotter JR., Proving the concept: moving ahead with PCORnets first clinical trial., http://www.pcori.org/blog/proving-concept-moving-ahead-pcornets-first-clinical-trial (29 2014,. accessed 23 January 2015).
33. Institute of Medicine Committee on Assessing the System for Protecting Human Research Participants. Responsible research: a systems approach to protecting research participants. Washington, DC: National Academies Press, 2002.
34. Emanuel EJ, Wendler D, Grady C., What makes clinical research ethical? JAMA 2000; 283: 2701-2711.
35. Cystic Fibrosis Foundation. Research overview., http://www.cff.org/research/ (. accessed 20 January 2015).
36. Giusti K., The Multiple Myeloma Research Foundations evolving focus on drug R&D. Nat Biotechnol 2012; 30: 600-603.
37. Miller FG, Rosenstein DL, DeRenzo EG., Professional integrity in clinical research. JAMA 1998; 280: 1449-1454.
38. White C, Gilshenan K, Hardy J., A survey of the views of palliative care healthcare professionals toward referring cancer patients to participate in randomized controlled trials in palliative care. Support Care Cancer 2008; 16: 1397-1405.
39. National Cancer Institute. An overview of NCIs National Clinical Trials Network., http://www.cancer.gov/clinicaltrials/nctn (. accessed 20 January 2015).