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
- October 19 @ 1:00 pm - 2:00 pm
Grand Rounds November 2: EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use DisorderNovember 2 @ 1:00 pm - 2:00 pm
- November 9 @ 1:00 pm - 2:00 pm
Grand Rounds November 30: Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome?November 30 @ 1:00 pm - 2:00 pm
- October 9, 2018: New Recommendations for Engaging Patients in Roles Other Than as Research Subjects A panel funded by the Patient-Centered Outcomes Research Institute (PCORI) recently published recommendations for the oversight of patients who participate in research roles other than as “research subject.” Patients and ...
- Podcast October 1, 2018: Returning Individual Research Results to Participants: Guidance for a New Research Paradigm In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Jeffrey Botkin and Dr. Consuelo Wilkins discuss returning individual research results to participants. In their conversation with Dr. Adrian Hernandez, ...
- October 1, 2018: Dr. Greg Simon Uses a Pie Eating Contest Analogy to Explain the Intraclass Correlation Coefficient In a new video, Dr. Greg Simon explains the intraclass correlation coefficient (ICC) with an analogy to a pie eating contest. The ICC is a descriptive statistic that measures the ...