Guidance for researchers developing and conducting clinical trials in practice-based research networks (PBRNs).
BACKGROUND
There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs.


METHODS
Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification.


RESULTS
The "Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks" offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials.


CONCLUSIONS
Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams.
From the Duke Clinical Research Institute, Duke University, Durham, NC (RJD); Department of Community and Family Medicine, Duke University Medical Center, Durham, NC (KMS); American Academy of Family Physicians National Research Network, Leawood, KS (DGG); DARTNet Institute, Wilmette, IL (DGG); Department of Family Medicine, University of Buffalo, Buffalo, NY (CHF); and the Department of Family Medicine, University of Washington, Seattle, WA (LMB). Rowena.dolor@duke.edu.
Rowena J
RJ
Dolor
From the Duke Clinical Research Institute, Duke University, Durham, NC (RJD); Department of Community and Family Medicine, Duke University Medical Center, Durham, NC (KMS); American Academy of Family Physicians National Research Network, Leawood, KS (DGG); DARTNet Institute, Wilmette, IL (DGG); Department of Family Medicine, University of Buffalo, Buffalo, NY (CHF); and the Department of Family Medicine, University of Washington, Seattle, WA (LMB).
Kristine M
KM
Schmit
From the Duke Clinical Research Institute, Duke University, Durham, NC (RJD); Department of Community and Family Medicine, Duke University Medical Center, Durham, NC (KMS); American Academy of Family Physicians National Research Network, Leawood, KS (DGG); DARTNet Institute, Wilmette, IL (DGG); Department of Family Medicine, University of Buffalo, Buffalo, NY (CHF); and the Department of Family Medicine, University of Washington, Seattle, WA (LMB).
Deborah G
DG
Graham
From the Duke Clinical Research Institute, Duke University, Durham, NC (RJD); Department of Community and Family Medicine, Duke University Medical Center, Durham, NC (KMS); American Academy of Family Physicians National Research Network, Leawood, KS (DGG); DARTNet Institute, Wilmette, IL (DGG); Department of Family Medicine, University of Buffalo, Buffalo, NY (CHF); and the Department of Family Medicine, University of Washington, Seattle, WA (LMB).
Chester H
CH
Fox
From the Duke Clinical Research Institute, Duke University, Durham, NC (RJD); Department of Community and Family Medicine, Duke University Medical Center, Durham, NC (KMS); American Academy of Family Physicians National Research Network, Leawood, KS (DGG); DARTNet Institute, Wilmette, IL (DGG); Department of Family Medicine, University of Buffalo, Buffalo, NY (CHF); and the Department of Family Medicine, University of Washington, Seattle, WA (LMB).
Laura Mae
LM
Baldwin
D002017:Budgets; D002986:Clinical Trials as Topic; D003142:Communication; D015337:Multicenter Studies as Topic; D010560:Personnel Selection
Clinical Trials as Topic; Practice-based Research