What kind of randomized trials do we need?

CMAJ. Canadian Medical Association Journal

Volumn 180, Issue 10, 2009, Pages 998-1000

  Zwarenstein, Merrick ^a   Treweek, Shaun ^b  

^a Sunnybrook Health Sciences Centre   (Canada)

^b UNIVERSITY OF DUNDEE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

COMPARATIVE STUDY; DRUG INDUSTRY; FUNDING; GOVERNMENT REGULATION; INTERVENTION STUDY; LICENSING; METHODOLOGY; NOTE; OUTCOME ASSESSMENT; PATIENT SELECTION; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; STATISTICAL SIGNIFICANCE;

EID: 65649086836     PISSN: 08203946     EISSN: 14882329     Source Type: Journal    
DOI: 10.1503/cmaj.082007     Document Type: Note

References (18)

1. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis 1967;20:637-48.
2. [Reprinted in J Clin Epidemiol 2009;62:499-505.]
3. Vallve C. A critical review of the pragmatic clinical trial Revisión crítica del ensayo clínico pragmático Medicina Clinica 2003 121 10 384-388 DOI 10.1157/13052554 2. Vallvé C. A critical review of the pragmatic clinical trial [Spanish]. Med Clin (Barc) 2003;27:384-388 (Pubitemid 37322580)
4. Fox W, Hill A. Streptomycin treatment of pulmonary tuberculosis. BMJ 1948;2:769-782
5. A brief history of the Center for Drug Evaluation and Research. Rockville (MD): Center for Drug Evaluation and Research, US Food and Drug Administration; 1997. p. 32. Available: www.fda.gov/cder/about/history/Page32.htm (accessed 2009 Feb. 12).
6. Investigational new drug application. Code of federal regulations. Title 21, Pt 312 (revised 2008 Apr. 1). Available: www.accessdata.fda.gov/scripts/ cdrh/cfdocs /cfcfr/CFRsearch.cfm?CFRPart=312 (accessed 2009 Feb. 12).
7. Drug study designs. In: Drugs and biologics. Guidance for institutional review boards and clinical investigators: 1998 update [information sheet]. Rockville (MD): US Food and Drug Administration; 1998. Available: www.fda.gov/oc/ohrt /irbs/drugsbiologics.html#study (accessed 2009 Feb. 12).
8. Tunis S.R. Stryer D.B. Clancy C.M. Practical Clinical Trials: Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy Journal of the American Medical Association 2003 290 12 1624-1632 DOI 10.1001/jama.290.12.1624 7. 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 (Pubitemid 37430387)
9. 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;62:464-75.
10. [Also in CMAJ 2009;180:E47-E57.]
11. Karanicolas PJ, Montori VM, Deveraux PJ, et al. A new "Mechanistic-Practical" framework for designing and interpreting randomized trials. J Clin Epidemiol 2009;62:479-484
12. Karanicolas PJ, Montori VM, Devereaux PJ, et al. The practicalists' response. J Clin Epidemiol 2009;62:489-494
13. Oxman AD, Lombard C, Treweek S, et al. Why we will remain pragmatists: four problems with the impractical mechanistic framework and a better solution. J Clin Epidemiol 2009;62:485-488
14. Oxman AD, Lombard C, Treweek S, et al. A pragmatic resolution. J Clin Epidemiol 2009;62:495-498
15. Maclure M. Explaining pragmatic trials to pragmatic policymakers. J Clin Epidemiol 2009;62:476-8.
16. [Also in CMAJ 2009;180:1001-3.]
17. Zwarenstein M, Treweek S, Gagnier J, et al.; CONSORT and Pragmatic Trials in Healthcare (Practihc) groups. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390.
18. Progressive licensing model. Ottawa (ON): Health Canada; 2007. Available: www.hc-sc.gc.ca/dhp-mps/homologation-licensing/model/index-eng.php (accessed 2009 Feb. 12).