Journal article
Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States
Contemporary clinical trials, Vol.33(6), pp.1211-1216
07/05/2012
DOI: 10.1016/j.cct.2012.07.002
PMCID: PMC3675785
PMID: 22796098
Abstract
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.
Details
- Title: Subtitle
- Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States
- Creators
- Kenneth G. Saag - University of Alabama at BirminghamPenny E. Mohr - Center for Medical Technology PolicyLaura Esmail - Center for Medical Technology PolicyAmy S. Mudano - University of Alabama at BirminghamNicole Wright - University of Alabama at BirminghamTimothy Beukelman - University of Alabama at BirminghamJeffrey R. Curtis - University of Alabama at BirminghamGary Cutter - University of Alabama at BirminghamElizabeth Delzell - University of Alabama at BirminghamLisa C. Gary - University of Alabama at BirminghamT. Michael Harrington - Center for Education and Research on Therapeutics (CERTs), Center for Outcomes Effectiveness Research and Education (COERE), and Center for Clinical and Translational Sciences (CCTS), University of Alabama at Birmingham, Birmingham, AL, United States Center for Medical Technology Policy, Baltimore, MD, United States Veterans Affairs Medical Center, Birmingham, AL, United States Ingenix Life Sciences, United States San Francisco Coordinating Center, University of California San Francisco, San Francisco, CA, United States Distributed Ambulatory Research in Therapeutics Network (DARTNet), American Academy of Family Physicians (AAFP), University of Colorado, Denver, CO, United States Brigham and Women’s Hospital, Boston, MA, United States University of Iowa, United StatesSwapna Karkare - Center for Medical Technology PolicyMeredith L. Kilgore - University of Alabama at BirminghamCora Elizabeth Lewis - University of Alabama at BirminghamRachael Moloney - Center for Medical Technology PolicyAna Oliveira - Center for Education and Research on Therapeutics (CERTs), Center for Outcomes Effectiveness Research and Education (COERE), and Center for Clinical and Translational Sciences (CCTS), University of Alabama at Birmingham, Birmingham, AL, United States Center for Medical Technology Policy, Baltimore, MD, United States Veterans Affairs Medical Center, Birmingham, AL, United States Ingenix Life Sciences, United States San Francisco Coordinating Center, University of California San Francisco, San Francisco, CA, United States Distributed Ambulatory Research in Therapeutics Network (DARTNet), American Academy of Family Physicians (AAFP), University of Colorado, Denver, CO, United States Brigham and Women’s Hospital, Boston, MA, United States University of Iowa, United StatesJasvinder A. Singh - Veterans Health AdministrationAmy Warriner - University of Alabama at BirminghamJie Zhang - University of Alabama at BirminghamMarc Berger - Ingenix Life Sciences, United StatesSteven R. Cummings - University of California, San FranciscoWilson Pace - American Academy of Family PhysiciansDaniel H. Solomon - Brigham and Women's HospitalRobert Wallace - University of IowaSean R. Tunis - Center for Medical Technology Policy
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials, Vol.33(6), pp.1211-1216
- DOI
- 10.1016/j.cct.2012.07.002
- PMID
- 22796098
- PMCID
- PMC3675785
- NLM abbreviation
- Contemp Clin Trials
- ISSN
- 1551-7144
- eISSN
- 1559-2030
- Grant note
- K23 AR053351 || AR / National Institute of Arthritis and Musculoskeletal and Skin Diseases : NIAMS UL1 RR025777 || RR / National Center for Research Resources : NCRR
- Language
- English
- Date published
- 07/05/2012
- Academic Unit
- Epidemiology; Injury Prevention Research Center; Internal Medicine
- Record Identifier
- 9984364450902771
Metrics
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