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.
By sharing lessons from our experience with pragmatic research, we aim to facilitate large-scale collaborative research studies with healthcare systems. The Living Textbook relies on the following knowledge sources:
DEMONSTRATION PROJECTS: Pragmatic clinical
trials that address questions of major public health importance and provide proof of concept for innovative pragmatic research designs.
CORES: Working groups that support the conduct of Demonstration Projects and generate guidance addressing implementation challenges.
DISTRIBUTED RESEARCH NETWORK: Network enabling investigators to collaborate in the use of electronic health data while safeguarding protected health information.
Upcoming Learning Opportunities
Grand Rounds October 20: Automated Public Health Surveillance Using Electronic Health Record Data (Michael Klompas MD, MPH, FIDSA, FSHEA)October 20 @ 1:00 pm - 2:00 pm
Grand Rounds October 27: Bringing Machine Learning to the Point of Care to Improve Suicide Prevention (Greg Simon, MD, MPH; Susan Shortreed, PhD; Don Mordecai, MD)October 27 @ 1:00 pm - 2:00 pm
- NIH Course on Biostatistics of Pragmatic and Group-Randomized Trials - Free 7-part online course
- October 16, 2017: NIH Collaboratory Core Working Group Interviews: Reflections from the Stakeholder Engagement Core At the NIH Collaboratory Steering Committee meeting in May 2017, we asked Ellen Tambor, a member of the Stakeholder Engagement Core, to reflect on the first 5 years of the Core’s work and the challenges ahead. She says it’s key for stakeholder engagement to take place throughout the entire healthcare system, from leadership to the ...
- October 11, 2017: New grant awarded to Dr. Jeffrey Jarvik and his team of investigators to promote pragmatic musculoskeletal clinical research Congratulations to Dr. Jeffrey Jarvik and his colleagues at the University of Washington for their recent grant award to establish the Core Center for Clinical Research (CCCR). The initiative will promote pragmatic, multi-institutional clinical research on musculoskeletal conditions, such as the diagnosis and treatment of back pain. The new center—the UW Center for Clinical Learning, ...
- October 10, 2017: NIH Collaboratory Core Working Group Interviews: Reflections from the Phenotypes, Data Standards, and Data Quality Core At the NIH Collaboratory Steering Committee meeting in May 2017, we asked Drs. Rachel Richesson and W. Ed Hammond, Co-chairs of the Phenotypes, Data Standards, and Data Quality Core, to reflect on the first 5 years of their Core’s work and the challenges ahead. Both were pleased with how the Core was able to provide guidelines ...