Building Partnerships and Teams to ensure a successful trial
Section 8
Framework for Health Systems to Assess PCT Participation
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.
SECTIONS
sections
- Introduction
- Engagement Across Settings and Populations
- Deciding Who to Engage
- Partner Engagement Throughout the PCT Life Cycle
- Advice From Healthcare System Leadership
- Embedded ePCT Team Composition
- Learning Health Systems and Embedded Clinical Trials
- Framework for Health Systems to Assess PCT Participation
- FAQ
REFERENCES
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.
current section : Framework for Health Systems to Assess PCT Participation
- Introduction
- Engagement Across Settings and Populations
- Deciding Who to Engage
- Partner Engagement Throughout the PCT Life Cycle
- Advice From Healthcare System Leadership
- Embedded ePCT Team Composition
- Learning Health Systems and Embedded Clinical Trials
- Framework for Health Systems to Assess PCT Participation
- FAQ