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NIH Collaboratory
Living Textbook of
Pragmatic Clinical Trials
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Rethinking Clinical Trials
A Living Textbook of Pragmatic Clinical Trials
Design
What is a Pragmatic Clinical Trial?
Decentralized Pragmatic Clinical Trials
Developing a Compelling Grant Application
Experimental Designs and Randomization Schemes
Endpoints and Outcomes
Analysis Plan
Using Electronic Health Record Data
Building Partnerships and Teams to Ensure a Successful Trial
Intervention Delivery and Complexity
Patient Engagement
Data, Tools & Conduct
Assessing Feasibility
Acquiring Real-World Data
Assessing Fitness-for-Use of Real-World Data
Study Startup
Participant Recruitment
Monitoring Intervention Fidelity and Adaptations
Patient-Reported Outcomes
Clinical Decision Support
Mobile Health
Electronic Health Records–Based Phenotyping
Navigating the Unknown
Dissemination & Implementation
Data Sharing and Embedded Research
Dissemination Approaches for Different Audiences
Implementation
End-of-Trial Decision-Making
Ethics & Regulatory
Privacy Considerations
Identifying Those Engaged in Research
Collateral Findings
Consent, Disclosure, and Non-Disclosure
Data and Safety Monitoring
Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
Ethics for AI and ML
IRB Responsibilities and Procedures
precis-2-wheel
Citation:
PRECIS-2 Case Study: precis-2-wheel. In:
Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at:
https://rethinkingclinicaltrials.org/chapters/design/what-is-a-pragmatic-clinical-trial/what-is-a-pragmatic-clinical-trial-precis-2-case-studyv2/precis-2-wheel/
. Updated July 31, 2025.
