Deciding Who to Engage – ARCHIVED

Engaging Stakeholders and Building Partnerships to Ensure a Successful Trial

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Deciding Who to Engage – ARCHIVED

version 1.0 - removed 12/15/2018



James Fraser

Rachael Moloney, MHS

Ellen Tambor, MA

Leah Tuzzio, MPH


Contributing Editors

Karen Staman, MS

Gina Uhlenbrauck
Archived December 13, 2018 Go to Latest Version

The table below shows the range of stakeholders that may participate in a PCT. Not every stakeholder is relevant to every PCT or at every stage of the research, but identifying these at the outset will set the stage for effective engagement planning. One approach to determining which categories of stakeholders are important for a particular PCT is to consider the following questions: 1) Who can help minimize potential barriers to study completion? and 2) Who will use the evidence from the study to make decisions or be affected by those decisions? For PCTs conducted in the context of healthcare delivery, healthcare delivery organization leaders, clinicians, and patients will always be important stakeholder groups (Moloney et al. 2016).


Potential PCT Stakeholders

Stakeholder Description
Patients, caregivers, and consumer advocacy groups Current and potential consumers of healthcare, their caregivers, families, and patient and consumer advocacy groups
Clinicians Physicians, nurses, mental health professionals, pharmacists, paramedics, and other providers of care and support services
Healthcare delivery organization leaders Chief executive officers, chief financial officers, chief operations officers, chief medical officers, directors, and other executive-level leaders or senior management within health systems, hospitals, skilled nursing facilities, and other healthcare delivery organizations
Operational personnel Operational managers, IT, billing, compliance, and other business operations staff
Payers and purchasers Private insurers, Medicare, Medicaid, employers, the self-insured, and state, government, and other entities responsible for reimbursing or underwriting the costs of healthcare
Policy-makers and regulators Department of Health and Human Services (e.g., US Food and Drug Administration, Office for Human Research Protections), Congress, the White House, states, professional associations, and other regulating or policy-making entities and their intermediaries
Research funders Government and private funders of research
Researcher Academic, industry, clinical, or patient investigator with a question
Product manufacturers Manufacturers of drugs and medical devices, electronic health record vendors

Adapted from (Concannon et al. 2012)


Healthcare Delivery Organization Leaders

Because PCTs are typically conducted using information in the electronic health record (EHR) and as part of routine care, they could not occur without the partnership and buy-in of a healthcare delivery organization. Several national initiatives have been involved in investigating challenges and practical strategies for integrating research in the setting of clinical care (Institute of Medicine 2013). According to a 2014 survey, health system executives are interested in research studies that support organizational performance goals; provide data to drive decision-making; enhance delivery-system reputation and national and community connections; and ultimately support the goal of high-quality, patient-centered care at a reasonable cost (Institute of Medicine 2015; Larson and Johnson 2015). Leaders were enthusiastic regarding the prospect of integrating knowledge generation into care, but wanted to minimize the impact of the research process on clinical operations and improve the speed and availability of research results. Healthcare delivery organization leaders are often gatekeepers, defined as “people or entities who can allow or deny access to resources required to support the conduct of clinical research.” (Patterson et al. 2011; Whicher et al. 2015). These individuals play a critical role in setting up an effective context to test the trial and in determining which PCTs are implemented and if the results of the trial become routine care. Aside from the essential early engagement with healthcare delivery organization leaders, operational personnel can offer insight crucial to the success of a PCT, such as an understanding of existing infrastructure and clinical workflows.

A lesson emphasized by Gregory Simon, MD, principal investigator of one of the NIH Collaboratory Demonstration Projects is, “researchers often have a tail-wagging-the-dog problem… we need to remember that we’re the tail and the healthcare system is the dog” (see full interview).


Even a highly developed and centralized healthcare delivery infrastructure does not obviate the need for local-level engagement with front-line clinicians and staff to facilitate successful trial completion (Tunis et al. 2016). Collaboratory investigators have cited the value of clinician engagement and how it is an important challenge to conducting PCTs. Overall, PCT researchers should have a communication plan, design training approaches that can be available on demand (e.g., recorded webinars) and updated as needed, be prepared to learn from their health system partners, and be flexible, adapting as needed to the dynamic study environment. Re-training and re-engagement will be needed due to staff turnover.


Including patients as partners throughout the research process through meaningful engagement can help PCTs be more patient centered, and may be a requirement for some research funding. Patient representatives might include individuals with lived experience of the disease or condition in question, family members or caregivers, or representatives from patient or consumer advocacy organizations. Decisions about who to include should be based on the topic and stage of research, the role patient representatives will be asked to play, the type of input that is needed, and the types of skills or experience required to participate meaningfully, among other factors. If relationships with patients and advocates do not already exist, advocacy organizations relevant to the disease or condition under study may be able to help identify patients who would be willing to serve as representative, or alternatively, to appoint a representative from their organization. Clinicians involved with the trial can also help to identify patient representatives. The Colorado Patient Partners in Research Campaign, a partnership between Kaiser Permanente and a local hospital, created a web-based system for matching patient partners with research teams in Colorado; they sent emails and launched a social media campaign to drive individuals to the website. PCT researchers should be prepared to build a trusting relationship, and to learn from, train, and provide time and space to collaborate with patient representatives.

Other Stakeholders

Other potential stakeholders include healthcare payers, policy-makers, and guideline developers who rely on the evidence from clinical trials to inform decisions that may affect large populations of patients and consumers. Enlisting the involvement of these stakeholder groups can be made easier if the PCT addresses questions that are of particular relevance. In some cases, it may also be useful to engage with relevant product manufacturers, consumer advocacy groups, or professional societies. However, in all cases, care should be taken to ensure that the interests of one stakeholder do not have undue influence on the research process.





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Concannon TW, Meissner P, Grunbaum JA, et al. 2012. A new taxonomy for stakeholder engagement in patient-centered outcomes research. J Gen Intern Med. 27:985–991. doi:10.1007/s11606-012-2037-1. PMID: 22528615.

Institute of Medicine. 2013. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Smith M, Saunders R, Stuckhardt L, McGinnis JM, editors. Washington, DC: National Academies Press. Accessed May 9, 2017.

Institute of Medicine. 2015. Integrating Research and Practice: Health System Leaders Working Toward High-Value Care: Workshop Summary. Washington, DC: National Academies Press. Accessed May 9, 2017.

Larson E, Johnson K. 2015. Making new care models a reality requires closer collaboration between researchers and execs. Modern Healthcare. Accessed 2017 May 9.

Moloney RM, Tambor ES, Tunis SR. 2016. Patient and clinician support for the learning healthcare system: recommendations for enhancing value. J Comp Eff Res. 5:123–128. doi:10.2217/cer.15.67. PMID: 26930026.

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

Patterson S, Mairs H, Borschmann R. 2011. Successful recruitment to trials: a phased approach to opening gates and building bridges. BMC Med Res Methodol. 11:73. doi:10.1186/1471-2288-11-73. PMID: 21595906.

Tunis S, Tambor E, Moloney R. 2016. Clinician Engagement in the NIH Collaboratory and Beyond. PCT Grand Rounds presentation; May 6, 2016.

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: Deciding Who to Engage – ARCHIVED. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated January 9, 2019. DOI: 10.28929/096.