Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States

Kenneth G. Saag, Penny E. Mohr, Laura Esmail, Amy S. Mudano, Nicole Wright, Timothy Beukelman, Jeffrey R. Curtis, Gary Cutter, Elizabeth Delzell, Lisa C. Gary, T. Michael Harrington, Swapna Karkare, Meredith L. Kilgore, Cora Elizabeth Lewis, Rachael Moloney, Ana Oliveira, Jasvinder A. Singh, Amy Warriner, Jie Zhang, Marc BergerSteven R. Cummings, Wilson Pace, Daniel H. Solomon, Robert Wallace, Sean R. Tunis

Research output: Contribution to journalArticlepeer-review

16 Scopus citations


Pragmatic clinical trials (PCTs) seek to improve the generalizability and increase the statistical power of traditional explanatory trials. They are a major tenet of comparative effectiveness research. While a powerful study design, PCTs have been limited by high cost, modest efficiency, and limited ability to fill relevant evidence gaps. Based on an American Reinvestment and Recovery Act (ARRA) supported meeting of national stakeholders, we propose several innovations and future research that could improve the efficiency and effectiveness of such studies focused in the U.S. Innovations discussed include optimizing the use of community based practices through partnership with Practice Based Research Networks (PBRNs), using information technology to simplify PCT subject recruitment, consent and randomization processes, and utilizing linkages to large administrative databases, such as Medicare, as a mechanism to capture outcomes and other important PCT variables with lower subject and research team burden. Testing and adaptation of such innovations to PCT are anticipated to improve the public health value of these increasingly important studies.

Original languageEnglish (US)
Pages (from-to)1211-1216
Number of pages6
JournalContemporary Clinical Trials
Issue number6
StatePublished - Nov 2012
Externally publishedYes


  • Comparative effectiveness research
  • Large simple trials
  • Practice Based Research Network
  • Pragmatic clinical trials

ASJC Scopus subject areas

  • Pharmacology (medical)
  • General Medicine


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