NIH Collaboratory provides guide to success for pragmatic clinical trials

Pragmatic clinical trials--real-life tests done in real-world settings--are increasingly important for answering pressing questions about how best to deliver health care. But these pragmatic trials require close collaboration between two professional groups who often have contrasting styles. One group is researchers, who follow structure like classical musicians. The other is and health care providers and administrators, who may need to improvise like jazz musicians. How in the world can such disparate players make beautiful music together?

"The key is not just to waltz in--but instead to get in tune with each other, make compromises, and 'rehearse' with pilot periods," said Karin E. Johnson, PhD, a research associate at Group Health Research Institute. She is the first author of "The BMJ, which stresses these steps: Build partnerships, define clinically important questions, assess feasibility, involve stakeholders in study design, and develop study workflows.

The guide is a product of interviews with pragmatic clinical trial experts, including people involved in demonstration pragmatic clinical trials supported by the Health Care Systems Research Collaboratory of the U.S. National Institutes of Health (NIH) and the REDUCE MRSA trial. The guide highlights the following lessons about building strong research partnerships between health researchers and health care systems:

  • Participating in pragmatic clinical trials can provide health care systems with evidence and tools to improve health care--and researchers with chances to do high-impact studies.
  • Pragmatic clinical trials answer questions that matter to health care systems. So clinicians, health care managers, health information technology, and clinical operations staff--and, increasingly, patients--should be involved in designing studies.

  • Successful pragmatic clinical trials start with a strong researcher-health care system partnership. They go through rigorous, objective evaluation of the partner health care system(s)'s ability to participate. And they produce long-term scientific relationships--and evidence about sustainable ways to improve care.

Pragmatic clinical trials are comparative effectiveness studies conducted in real-world settings to answer questions that matter to patients, clinicians, and health care decision makers, Dr. Johnson explained. They include some randomized trials. By contrast, explanatory clinical trials study how treatments or interventions work in carefully controlled settings and study populations, often to investigate a biological hypothesis or test a drug or device to meet regulatory requirements.

"This guide is a product of the Collaboratory's Health Care Systems Interactions Workgroup," said Dr. Johnson's coauthor Eric. B. Larson, MD, MPH, the executive director and a senior investigator at Group Health Research Institute and Group Health's vice president for research. "We're excited about sharing the valuable lessons that we've learned about how best to create and sustain research partnerships for pragmatic clinical trials in a widely read and prestigious journal like The BMJ."

Members of the NIH's Health Care Systems Research Collaboratory overlap with those of the HMO Research Network, which includes 18 research centers, each associated with a health care delivery system. When this guide was presented at the 2014 annual conference of the HMO Research Network, it was chosen as its first annual "paper of the year."

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