NCCIH Research Blog

The National Institutes of Health (NIH) Health Care Systems Research Collaboratory is working to transform the way clinical trials are conducted, by actually conducting research within usual care settings in health care systems. Ultimately, the goal of these pragmatic clinical trials (PCT) is to inform health and health care decisionmaking by providers, patients, and policymakers based on real-world clinical evidence. PCT address major public health questions in real-world settings with highly generalizable populations and can produce clinical evidence more quickly and at lower cost than in many traditional clinical trials. Staff of NCCIH and the National Institute on Aging have been leading the NIH Collaboratory, which launched in 2012 and has supported 19 projects.  

Since 2016, the NIH Collaboratory has held annual 1-day workshops at NIH to share the many lessons learned from these trials, which focus on different diseases. The PCT investigators and many clinical trial experts have participated in these workshops to discuss the various challenges and potential solutions for conducting PCT, as well as new opportunities in other settings. 

This year, I am excited to announce that the NIH Collaboratory will instead host a different type of meeting - a Grand Rounds Workshop Series streamed online on four Fridays in May and June 2020. Our overall theme is “Advances at the Intersection of Digital Health, Electronic Health Records (EHRs), and Pragmatic Clinical Trials.” Each meeting will provide insights into how these three facets of health care intersect. The events will be streamed from 1 to 2 p.m. ET on May 1, 8, and 29, and June 26. Registration is not required, and access is free of charge. Sessions will be archived. 

All Grand Rounds sessions, including the keynote lecture on May 1, will include a moderated panel discussion focusing on the use of digital technologies in PCT. Included will be lessons learned from the Demonstration Projects and stakeholders and on advancing the clinical research enterprise in a changing health care environment. We will close with a summary podcast on July 7. 

Our May 1st keynote lecture will address a topic of high importance, “Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?” Speaker Robert Califf, M.D., is the Donald F. Fortin, M.D. Distinguished Professor of Cardiology at Duke University School of Medicine and head of strategy and policy at Google Health and Verily Life Sciences. In 2016-2017, he served as Commissioner of the U.S. Food and Drug Administration. 

Subsequent meetings will feature moderated panels on: 

• May 8: “Real World Evidence: Contemporary Experience and Future Directions”
• May 29: “Experiences from the Collaboratory PCTs”
• June 26: “Keys to Success in the Evolving EHRs Environment”
• July 7: “Summary Expert Panel Discussion” (podcast). 

Previous NIH Collaboratory workshops have focused on unique aspects of PCT planning and implementation, such as design and analysis, ethical oversight, dissemination and implementation, and testing of complicated treatment interventions. We have learned much about PCT from the Collaboratory. Its moderated discussions are always lively and productive, so we hope you can join us virtually.

For More Information

• View the full agenda, details on how to join the events, and additional resources at the NIH Collaboratory website. (Scroll to the bottom of the page to view “Upcoming Learning Opportunities”)