Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States.
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.
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
Kenneth G
KG
Saag
Penny E
PE
Mohr
Laura
L
Esmail
Amy S
AS
Mudano
Nicole
N
Wright
Timothy
T
Beukelman
Jeffrey R
JR
Curtis
Gary
G
Cutter
Elizabeth
E
Delzell
Lisa C
LC
Gary
T Michael
TM
Harrington
Swapna
S
Karkare
Meredith L
ML
Kilgore
Cora Elizabeth
CE
Lewis
Rachael
R
Moloney
Ana
A
Oliveira
Jasvinder A
JA
Singh
Amy
A
Warriner
Jie
J
Zhang
Marc
M
Berger
Steven R
SR
Cummings
Wilson
W
Pace
Daniel H
DH
Solomon
Robert
R
Wallace
Sean R
SR
Tunis
D000367:Age Factors; D057171:American Recovery and Reinvestment Act; D002986:Clinical Trials as Topic / Q000379:methods*; D003153:Community Health Services / Q000458:organization & administration*; D057186:Comparative Effectiveness Research / Q000458:organization & administration*; D017598:Efficiency, Organizational; D006801:Humans; D020407:Internet; D017063:Outcome Assessment, Health Care; D014481:United States