Improving the efficiency and effectivene... [Contemp Clin Trials. 2012] - PubMed - NCBI

Improving the efficiency and effectivene... [Contemp Clin Trials. 2012] - PubMed - NCBI

Contemp Clin Trials. 2012 Nov;33(6):1211-6. doi: 10.1016/j.cct.2012.07.002. Epub 2012 Jul 5.

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

Saag KG, Mohr PE, Esmail L, Mudano AS, Wright N, Beukelman T, Curtis JR, Cutter G, Delzell E, Gary LC, Harrington TM, Karkare S, Kilgore ML, Lewis CE, Moloney R, Oliveira A, Singh JA, Warriner A, Zhang J, Berger M, Cummings SR, Pace W, Solomon DH, Wallace R, Tunis SR.

Source

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, USA. ksaag@uab.edu

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.
Copyright © 2012 Elsevier Inc. All rights reserved.

PMID:

22796098

[PubMed - indexed for MEDLINE]