Stakeholder Engagement Throughout the PCT Life Cycle

Building partnerships to ensure a successful trial

Section 3

Stakeholder Engagement Throughout the PCT Life Cycle


James Fraser

Rachael Moloney, MHS

Ellen Tambor, MA

Leah Tuzzio, MPH


Contributing Editors

Karen Staman, MS

Gina Uhlenbrauck

Engagement of key stakeholder groups is critical across the research continuum, from making sure the right questions are asked to ensuring that study findings make it into the hands of health and healthcare decision-makers. Three broad stages for involving stakeholders include: 1) planning the study, 2) conducting the study, and 3) disseminating the results (PCORI 2015). Ways in which stakeholders might contribute at each stage are presented in the Figure and summary below.

  • Choosing a research question
  • Designing the intervention and informing on potential sustainability
  • Selecting outcome measures
  • Determining inclusion and exclusion criteria
  • Designing the study protocol to minimize burden for patients and clinicians
  • Determining study requirements (e.g., regulatory)
  • Promoting and supporting the study
  • Drafting/reviewing study materials
  • Providing resources

  • Developing recruitment strategies
  • Promoting and assessing compliance with study requirements (e.g., regulatory)
  • Serving as study champions
  • Assisting with strategies for participant retention
  • Solving problems and removing barriers
  • Considering privacy and data sharing issues
  • Advising on analyses
  • Interpreting study results

  • Determining key messages for different stakeholder groups
  • Identifying avenues for dissemination
  • Assisting with the development of manuscripts and other dissemination materials
  • Sharing findings via professional networks and social media
  • Supporting implementation or de-implementation of intervention
  • Considering changes to policies and guidelines

Planning the Study

Engagement of key stakeholder groups ideally begins with the selection of a research topic, and many organizations employ a multi-stakeholder process of topic prioritization (National Institute for Health Research 2016; PCORI). This ensures that resources are allocated to studies that will answer questions of greatest importance to decision-makers, and also increases the likelihood that a study will receive the support it needs for successful implementation. As noted above, PCTs that answer questions that matter to healthcare delivery organizations, clinicians, and patients are more likely to garner support. In choosing whether to support a PCT, it is recommended that decision-makers respect, promote, or represent the interests of those likely to be directly or indirectly affected; advance organizational mission and values; and consider stewardship of resources (financial, human, and organizational) (Whicher et al. 2015).

Once a research question has been selected, stakeholders can contribute to study planning in a number of ways. For example, patient representatives can identify health outcomes that are important to them that researchers may not have thought to measure. A different set of outcomes related to resource utilization may be important to healthcare payers. Involving clinicians and other clinic staff in designing the study protocol can help minimize the trial’s impact on clinical workflow, which is particularly important for PCTs.

Conducting the Study

Stakeholders can continue to play an important role during study implementation. While not everything about a PCT will work as initially planned, seemingly insurmountable problems usually have solutions, and well-established engagement throughout a trial can help prevent or overcome such roadblocks. Because healthcare systems are dynamic, PCTs require continued efforts to establish, maintain, and re-establish engagement through leadership or staff changes. Patient and clinician stakeholders can contribute to the development of communication materials and data collection instruments that are understandable and easy to use. Patients and patient advocates can also provide valuable insight regarding strategies that will motivate patients to enroll in the study and remain engaged throughout the study. Once data collection is completed, stakeholders can help to plan analyses and interpret results.

Disseminating the Results

Stakeholders can enhance dissemination by helping to translate study findings for diverse audiences and identifying avenues for dissemination beyond the traditional scientific literature. The PCORI Dissemination and Implementation Framework provides detailed information and tools for designing and implementing a robust dissemination strategy informed by multiple stakeholder groups. Additional information can also be found in the Living Textbook chapter, Dissemination Approaches for Different Stakeholders.



Dissemination Approaches for Different Stakeholders

Living Textbook chapter

PCORI Dissemination and Implementation Framework

Provides information and tools for designing and implementing a robust dissemination strategy informed by multiple stakeholder groups

In a video interview, Drs. Susan Huang and Gloria Coronado give advice to pragmatic trial investigators, including a recommendation to engage operational partners within the sites.


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National Institute for Health Research. 2016. The James Lind Alliance Guidebook. Accessed May 9, 2017.

PCORI. 2015. PCORI Engagement Rubric. Accessed May 9, 2017.

PCORI. Generation and Prioritization of Topics for Funding Announcements. Accessed May 9, 2017.

Whicher DM, Miller JE, Dunham KM, Joffe S. 2015. Gatekeepers for pragmatic clinical trials. Clin Trials. 12:442–448. doi:10.1177/1740774515597699. PMID: 26374683.

Version History

Published August 25, 2017


Fraser J, Moloney R, Tambor E, Tuzzio L. Building partnerships to ensure a successful trial: Stakeholder Engagement Throughout the PCT Life Cycle. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated November 30, 2018. DOI: 10.28929/097.