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NIH Collaboratory
Living Textbook of
Pragmatic Clinical Trials

COVID-19 Resources

Access the latest information on COVID-19 for clinical researchers
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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
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Uses of the NIH Collaboratory Distributed Research Network (DRN)

March 11, 2016 @ 1:00 pm - 2:00 pm
  • « Patient-Focused Benefit-Risk Assessment
  • Ethical Responsibilities Toward Indirect and Collateral Participants in Pragmatic Clinical Trials »

Presenter: Brown, Jeffrey

Slides: Slides

Video: Grand-Rounds-03-11-16

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Details

  • Date: March 11, 2016
  • Time:
    1:00 pm - 2:00 pm
  • Event Category: Grand Rounds Archives
  • « Patient-Focused Benefit-Risk Assessment
  • Ethical Responsibilities Toward Indirect and Collateral Participants in Pragmatic Clinical Trials »

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