Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
Welcome to the Living Textbook of pragmatic clinical trials, a collection of knowledge from the NIH Health Care Systems Research Collaboratory. Pragmatic clinical trials are performed in real-world clinical settings with highly generalizable populations to generate actionable clinical evidence at a fraction of the typical cost and time needed to conduct a traditional clinical trial. They present an opportunity to efficiently address critical knowledge gaps and generate high-quality evidence to inform medical decision-making. However, these trials pose different challenges than are typically encountered with traditional clinical trials. The Living Textbook reflects a collection of expert consensus regarding special considerations, standard approaches, and best practices in the design, conduct, and reporting of pragmatic clinical trials. Given the rapid pace of change in this field, this electronic textbook will continue to be added to and updated.
Pragmatic clinical trials that address questions of major public health importance and provide proof of concept for innovative pragmatic research designs.
Working groups that support the conduct of Demonstration Projects and generate guidance addressing implementation challenges.
Network enabling investigators to collaborate in the use of electronic health data while safeguarding protected health information.
Upcoming Learning Opportunities
Grand Rounds September 20: Designing & Testing the Future of Home-based Cervical Cancer Screening: Results from a Collaborative Academic-Embedded Delivery System Pragmatic Randomized TrialSeptember 20 @ 1:00 pm - 2:00 pm
Grand Rounds September 27: Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for ResearchersSeptember 27 @ 1:00 pm - 2:00 pm
Grand Rounds October 4: Ascertaining Death and Hospitalization Endpoints: The TRANSFORM-HF ExperienceOctober 4 @ 1:00 pm - 2:00 pm
Grand Rounds October 11: Objecting to Experiments that Compare Two Unobjectionable Policies or Treatments: Implications for Comparative Effectiveness and Other Pragmatic Clinical TrialsOctober 11 @ 1:00 pm - 2:00 pm
- September 13, 2019: HiLo Awarded Continuation From Planning to Implementation Phase The investigators of HiLo, an NIH Collaboratory Demonstration Project, have received approval to move from the planning phase to the implementation phase of their study. Congratulations to Dr. Myles Wolf ...
- September 11, 2019: Deadline Extended for Special Supplement Seeking Papers on Embedded Research The submission deadline has been extended to October 28, 2019, for a special supplement on embedded health services research in Healthcare: The Journal of Delivery Science and Innovation, the partner ...
- September 10, 2019: NIA IMPACT Collaboratory Announces Pilot Grant Funding Opportunity The National Institute on Aging (NIA) Imbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory is soliciting letters of intent for several 1-year pilot grant awards of up to $150,000. The awards ...