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 journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1211-1216
Number of pages6
JournalContemporary Clinical Trials
Volume33
Issue number6
DOIs
StatePublished - Nov 2012
Externally publishedYes

Fingerprint

Pragmatic Clinical Trials
American Recovery and Reinvestment Act
Partnership Practice
Comparative Effectiveness Research
Information Services
Random Allocation
Medicare
Research
Public Health
Databases
Technology
Costs and Cost Analysis

Keywords

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

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)

Cite this

Saag, K. G., Mohr, P. E., Esmail, L., Mudano, A. S., Wright, N., Beukelman, T., ... Tunis, S. R. (2012). Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States. Contemporary Clinical Trials, 33(6), 1211-1216. https://doi.org/10.1016/j.cct.2012.07.002

Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States. / Saag, Kenneth G.; Mohr, Penny E.; Esmail, Laura; Mudano, Amy S.; Wright, Nicole; Beukelman, Timothy; Curtis, Jeffrey R.; Cutter, Gary; Delzell, Elizabeth; Gary, Lisa C.; Harrington, T. Michael; Karkare, Swapna; Kilgore, Meredith L.; Lewis, Cora Elizabeth; Moloney, Rachael; Oliveira, Ana; Singh, Jasvinder A.; Warriner, Amy; Zhang, Jie; Berger, Marc; Cummings, Steven R.; Pace, Wilson; Solomon, Daniel H.; Wallace, Robert; Tunis, Sean R.

In: Contemporary Clinical Trials, Vol. 33, No. 6, 11.2012, p. 1211-1216.

Research output: Contribution to journalArticle

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 2012, 'Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States', Contemporary Clinical Trials, vol. 33, no. 6, pp. 1211-1216. https://doi.org/10.1016/j.cct.2012.07.002
Saag, Kenneth G. ; Mohr, Penny E. ; Esmail, Laura ; Mudano, Amy S. ; Wright, Nicole ; Beukelman, Timothy ; Curtis, Jeffrey R. ; Cutter, Gary ; Delzell, Elizabeth ; Gary, Lisa C. ; Harrington, T. Michael ; Karkare, Swapna ; Kilgore, Meredith L. ; Lewis, Cora Elizabeth ; Moloney, Rachael ; Oliveira, Ana ; Singh, Jasvinder A. ; Warriner, Amy ; Zhang, Jie ; Berger, Marc ; Cummings, Steven R. ; Pace, Wilson ; Solomon, Daniel H. ; Wallace, Robert ; Tunis, Sean R. / Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States. In: Contemporary Clinical Trials. 2012 ; Vol. 33, No. 6. pp. 1211-1216.
@article{ceaa35c2a8154ce392fbc4bcba7ef964,
title = "Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States",
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.",
keywords = "Comparative effectiveness research, Large simple trials, Practice Based Research Network, Pragmatic clinical trials",
author = "Saag, {Kenneth G.} and Mohr, {Penny E.} and Laura Esmail and Mudano, {Amy S.} and Nicole Wright and Timothy Beukelman and Curtis, {Jeffrey R.} and Gary Cutter and Elizabeth Delzell and Gary, {Lisa C.} and Harrington, {T. Michael} and Swapna Karkare and Kilgore, {Meredith L.} and Lewis, {Cora Elizabeth} and Rachael Moloney and Ana Oliveira and Singh, {Jasvinder A.} and Amy Warriner and Jie Zhang and Marc Berger and Cummings, {Steven R.} and Wilson Pace and Solomon, {Daniel H.} and Robert Wallace and Tunis, {Sean R.}",
year = "2012",
month = "11",
doi = "10.1016/j.cct.2012.07.002",
language = "English (US)",
volume = "33",
pages = "1211--1216",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
number = "6",

}

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

UR - http://www.scopus.com/inward/citedby.url?scp=84867222158&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2012.07.002

DO - 10.1016/j.cct.2012.07.002

M3 - Article

C2 - 22796098

AN - SCOPUS:84867222158

VL - 33

SP - 1211

EP - 1216

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

IS - 6

ER -