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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?
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
Data Sharing and Embedded Research
Dissemination and Implementation
Dissemination Approaches for Different Stakeholders
Ethics and Regulatory
Privacy Considerations
Identifying Those Engaged in Research
Consent, Waiver of Consent, and Notification
Collateral Findings
Data and Safety Monitoring
Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
Ethics and Equity for AI and ML
The Logistics of Using a Single IRB
Analysis Plan
Citation:
Analysis Plan: Analysis Plan. In:
Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at:
https://rethinkingclinicaltrials.org/chapters/design/analysis-plan-top/
. Updated April 17, 2018.
