TY - JOUR
T1 - Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States
AU - Saag, Kenneth G.
AU - Mohr, Penny E.
AU - Esmail, Laura
AU - Mudano, Amy S.
AU - Wright, Nicole
AU - Beukelman, Timothy
AU - Curtis, Jeffrey R.
AU - Cutter, Gary
AU - Delzell, Elizabeth
AU - Gary, Lisa C.
AU - Harrington, T. Michael
AU - Karkare, Swapna
AU - Kilgore, Meredith L.
AU - Lewis, Cora Elizabeth
AU - Moloney, Rachael
AU - Oliveira, Ana
AU - Singh, Jasvinder A.
AU - Warriner, Amy
AU - Zhang, Jie
AU - Berger, Marc
AU - Cummings, Steven R.
AU - Pace, Wilson
AU - Solomon, Daniel H.
AU - Wallace, Robert
AU - Tunis, Sean R.
PY - 2012/11
Y1 - 2012/11
N2 - 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.
AB - 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.
KW - Comparative effectiveness research
KW - Large simple trials
KW - Practice Based Research Network
KW - Pragmatic clinical trials
UR - http://www.scopus.com/inward/record.url?scp=84867222158&partnerID=8YFLogxK
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U2 - 10.1016/j.cct.2012.07.002
DO - 10.1016/j.cct.2012.07.002
M3 - Article
C2 - 22796098
AN - SCOPUS:84867222158
SN - 1551-7144
VL - 33
SP - 1211
EP - 1216
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 6
ER -