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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

Framework for Health Systems to Assess PCT Participation

CHAPTER SECTIONS

Building Partnerships and Teams to ensure a successful trial


Section 8

Framework for Health Systems to Assess PCT Participation

Expand Contributors

Stephanie Morain, PhD

Contributing Editor

Terren Green

Healthcare systems considering participation in a PCT must weigh institutional priorities when deciding whether to embed a trial into ongoing clinical care. An article led by a co-chair of the NIH Pragmatic Trials Collaboratory Ethics and Regulatory Core proposes a framework by which healthcare systems can assess the appropriateness and feasibility of a given PCT for their system (Morain et al 2025).

This framework proposes 3 lines of inquiry:

  • What is the importance and timeliness of the research question?

Does the PCT address an issue of clinical or operational importance? How much evidence exists to support the intervention’s efficacy? Is there a need for more evidence about outcomes in routine settings? Does variation regarding optimal treatment support the need for additional evidence to inform care?

  • How feasibly can the study be conducted within the healthcare system?

What is the likelihood of enrolling a sample size sufficient to answer the research question? Are the necessary data available to conduct, monitor, and interpret the trial? How readily can the study protocol be integrated into existing workflows? Are relevant clinicians and operational leaders supportive?

  • Is the healthcare system willing to act on the study results?

Will the trial collect the necessary metrics to support institutional decision-making about de-implementation or sustainment?

The lines of inquiry in this framework serve to open a conversation among members of the research team, clinicians, and healthcare system leaders to determine appropriate fit of the PCT for the given healthcare system and best methods for embedding the PCT into practice.

Previous Section Next Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Engagement Across Settings and Populations
  3. Deciding Who to Engage
  4. Partner Engagement Throughout the PCT Life Cycle
  5. Advice From Healthcare System Leadership
  6. Embedded ePCT Team Composition
  7. Learning Health Systems and Embedded Clinical Trials
  8. Framework for Health Systems to Assess PCT Participation
  9. FAQ

REFERENCES

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Morain SR, Semler MW, Casey JD. 2025. A framework for health systems to assess and prioritize participation in pragmatic clinical trials. Learn Health Syst. Online ahead of print. https://doi.org/10.1002/lrh2.70016.

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Version History

Published July 16, 2025

current section :

Framework for Health Systems to Assess PCT Participation

  1. Introduction
  2. Engagement Across Settings and Populations
  3. Deciding Who to Engage
  4. Partner Engagement Throughout the PCT Life Cycle
  5. Advice From Healthcare System Leadership
  6. Embedded ePCT Team Composition
  7. Learning Health Systems and Embedded Clinical Trials
  8. Framework for Health Systems to Assess PCT Participation
  9. FAQ

Citation:

Building Partnerships and Teams to ensure a successful trial: Framework for Health Systems to Assess PCT Participation. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/engaging-stakeholders/framework-for-health-systems-to-assess-pct-participation/. Updated July 22, 2025. DOI: 10.28929/261.

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