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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

Conclusion

CHAPTER SECTIONS

Ethics for Artificial Intelligence and Machine Learning in Pragmatic Clinical Trials


Section 5

Conclusion

Expand Contributors

Vasiliki N. Rahimzadeh, PhD
Kaitlyn Jaffe, PhD
Kayte Spector-Bagdady, JD, MBE

Contributing Editor

Elizabeth McCamic, MA

Translating digital PCT findings that leverage AI/ML into improved health outcomes for all patients rests on the use of well-managed and representative datasets. Both over- and underrepresentation in AI/ML training datasets are problematic for downstream uses and can lead to patient harms. Investigators should understand how algorithmic biases can enter the AI/ML training pipeline and develop practical ways correct them.

Previous Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Institutional Review Board Approval
  3. Data Procurement and Consent
  4. Training Data Generation
  5. Conclusion


Version History

Published November 7, 2023

current section :

Conclusion

  1. Introduction
  2. Institutional Review Board Approval
  3. Data Procurement and Consent
  4. Training Data Generation
  5. Conclusion

Citation:

Rahimzadeh V, Jaffe K, Spector-Bagdady K. Ethics for Artificial Intelligence and Machine Learning in Pragmatic Clinical Trials: Conclusion. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/ethics-and-regulatory/ethics-and-equity-for-ai-and-ml/conclusion/. Updated December 3, 2025. DOI: 10.28929/235.

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