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Pragmatic Clinical Trials resources

Early Pharmaceutical Pragmatic Clinical Trials (December 2013)
A white paper on the historical context for a discussion about pragmatic clinical trials and their place in drug approval.
NIH Collaboratory Stakeholder Engagement Core (July 2013)
Sean Tunis presented at NIH Collaboratory Grand Rounds on the first meeting of the SAG
Improving the Efficiency and Effectiveness of Pragmatic Clinical Trials in Older Adults in the United States.
Saag KG, Mohr PE, Esmail L, Wright N, Curtis JR, Cutter G, Delzell E, Gary LC, Lewis CE, Harrington TM, Karkare SU, Kilgore ML, Moloney R, Mudano AS, Oliveira A, Singh J, Warriner A, Zhang J, Berger M, Cummings SR, Pace W, Solomon DH, Wallace R, Tunis SR. Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States. Contemp Clin Trials. 2012;33(6)1211-1216. doi: 10.1016/j.cct.2012.07.002. PMID: 22796098
Opportunities and Challenges for Comparative Effectiveness Pragmatic Clinical Trials in Europe
Donna Messner was part of this panel session at the 14th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research. Other participants were Marc L. Berger, David Price, and Finn B??rlum Kristensen.
Medicare Data United with Simple Clinical Trials Expanded (May 2011)
This collaborative 'network of networks ' was formed to provide the research infrastructure for trials to study comparative effectiveness of therapeutics in the treatment and management of chronic diseases. CMTP led a workshop on CER in Osteoporosis in May 2011.
Pragmatic Phase 3 Pharmaceutical Trials: Recommendations for the Design of Clinical Trials that Are More Informative for Patients, Clinicians, and Payers (September 2010)
This EGD provides recommendations to guide the implementation of pragmatic study designs for phase 3 pharmaceutical trials. Pragmatic Clinical Trials (PCTs) are designed to assist patients, clinicians, and payers in making informed decisions about alternative drug therapies.
A Pragmatic Explanatory Continuum Indicator Summary (PRECIS) Was Useful for Refining a Randomized Trial Design: Experiences from an Investigative Team (March 2010)
D.L. Riddle et al. / Journal of Clinical Epidemiology 63 (2010) 1271e1275
Designing More Informative Clinical Trials for New Indications of Oncology Drugs, November 2009
CMTP hosted a one day Think Tank on November 12, 2009 with more than 60 experts and stakeholders to reach consensus on better ways to more frequently and consistently design, fund, and implement prospective clinical studies of new indications for oncology drugs that will be more informative to post-regulatory decisionmakers.
Methodological Guidance for the Design of Pragmatic Pharmaceutical Clinical Trials, May 2009
Summary of a meeting held in May 2009 of a multi-stakeholder workgroup brought together by Center for Medical Technology Policy (CMTP) to characterize recurring gaps in evidence that are often not sufficiently addressed in regulatory trials, explore the reason for these gaps, and begin to elucidate potential solutions.
PRECIS: The Pragmatic Explanatory Continuum Indicator Summary (April 2009)
Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis SR, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): A tool to help trial designers. CMAJ. 2009;180(10):E47-57. doi: 10.1503/cmaj.090523. PMID: 19372436