Additional Resources

Study Startup

Additional Resources


Lynn DeBar, PhD, MPH

Jeffrey G. Jarvik, MD, MPH

Leah Tuzzio, MPH

Miguel Vazquez, MD


Contributing Editor

Liz Wing, MA

Resource Description
White papers and guidance
Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures This document helps PCT study teams plan training for study procedures that involve front-line clinicians and staff. The content was developed by drawing on trial-specific experience from the NIH Collaboratory Demonstration Projects. The document describes how training for PCTs will differ from training conducted for typical research studies, and includes a list of specific considerations, real-world examples, a checklist for PCT training design, and links to additional resources.
Lessons Learned from the NIH Health Care Systems Research Collaboratory Demonstration Projects This document presents problems and solutions for PCT initiation and implementation based on trial-specific experience from the NIH Collaboratory Demonstration Projects. For each demonstration project, problems and solutions are listed as they pertain to building partnerships, defining clinically important questions, assessing feasibility, involving stakeholders in study design, developing study workflows, and considering potential Institutional Review Board (IRB), regulatory and biostatistical issues.
Online training
Center for Research Implementation Science and Prevention (CRISP) Pragmatic Trials Workshop Handbook An online course and resources for researchers to learn about conducting pragmatic clinical trials.
Journal articles
Communication is the key to success in pragmatic clinical trials in Practice-based Research Networks (PBRNs)

Bertram S, et al. J Am Board Fam Med 2013

Effective communication is the foundation of feasibility and fidelity in practice-based pragmatic research studies. Doing a study with practices spread over several states requires long-distance communication strategies, including e-mails, faxes, telephone calls, conference calls, and texting. Developing and ensuring comfort with distance communications requires additional time and use of different talents and expertise than those required for face-to-face communication. This discussion is based on extensive experience of 2 groups who have worked collaboratively on several large, federally funded, pragmatic trials in a practice-based research network.
Trials without tribulations: minimizing the burden of pragmatic research on healthcare systems

Larson EB, et al. Healthcare 2015

Pragmatic clinical trials are increasingly common because they have the potential to yield findings that are directly translatable to real-world healthcare settings. Pragmatic clinical trials need to integrate research into the clinical workflow without placing an undue burden on the delivery system. This requires a research partnership between investigators and healthcare system representatives.
A guide to research partnerships for pragmatic clinical trials

Johnson KE, et al. BMJ 2014

A successful pragmatic clinical trial starts with a strong partnership between researcher and healthcare system, goes through a rigorous objective evaluation of the ability of the partner healthcare system to participate, and ends with evidence about sustainable ways to improve care, as well as a long term scientific relationship.





Additional Resources: Additional Resources. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated June 25, 2018.