Stakeholder Engagement

Stakeholder Engagement

All people – including patients, caregivers, community partners, and other stakeholders – bring value to clinical research and should be involved as partners in every stage of the research process.

Our Thinking

For too long people outside of the research world have not been embraced as full partners in the design and conduct of clinical research. The DCRI believes that all people – including patients, caregivers, community partners and other stakeholders – should be partners in research.

These stakeholders have the potential to impact every stage of the clinical trial life cycle, including study design, funding, recruitment, protocol development, monitoring, data analysis, and FDA approval.

Bray Patrick-Lake
Director of Stakeholder Engagement

"There are no didactic presentations or transactional approaches that can be substituted for respectful partnerships, dedication to mentoring, and working hand-in-hand with patient advocates."

Bray Patrick-Lake

Research Together. What Is It?

At the DCRI, Research Together means that researchers and stakeholders work together at every step of the research process. Research Together means that relationships are bidirectional – everyone learns from each other and everyone gains value.

DCRI’s Research Together program provides sponsors and investigators with access to DCRI thought leaders who understand the science of engagement. 

The Research Together program is led by Bray Patrick-Lake, MFS, Director of Stakeholder Engagement at the DCRI, and supported by a team of Communicators, Clinical Project Leads, and Participant Engagement Liaisons.

Email or call 919-668-9210 to discuss your research needs and reach the appropriate engagement team.  


The Making Of A Patient Advocate


Key characteristics can help identify patient partners who may become knowledgeable and skilled research advocates, but their growth and skillful contribution are highly dependent on co-learning and investments made by other stakeholders in the clinical trials enterprise.

Adrian Hernandez

Listening to the Patient


Adrian Hernandez, MD, DCRI cardiologist and principal investigator, and Patient Partner Lesley Maisch discuss how patients are redefining the way clinical trials are conducted in the context of the PROSPER trial.

Want more from Adrian and Lesley on the power of patients and the value of their feedback? Read their blog post.

When Should Patients Be Involved in Clinical Trial Design?


Bray Patrick-Lake and Adrian Hernandez discuss patient involvement as a way to better understand stakeholder needs and opportunities, maximize their contributions, and optimize clinical trials.

Collaboration: The Clinical Trials Transformation Initiative

Situated within the DCRI, the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration, seeks to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials.

CTTI’s membership now comprises more than 80 organizations from across the clinical trials enterprise, and it is this diverse representation of stakeholders that makes CTTI uniquely positioned to develop evidence-based solutions to clinical research challenges. Many regulatory agencies and organizations have applied CTTI’s nearly 20 existing recommendations, and associated resources, to make better clinical trials a reality. Read CTTI’s recommendations for enhancing participation and engagement of patient groups in medical product development.

Bray Patrick-Lake


Bray Patrick-Lake, MFS
Director, Stakeholder Engagement

Bray Patrick-Lake, MFS, serves as director of stakeholder engagement for the DCRI. She leads the DCRI’s participant engagement work on Project Baseline, a partnership with Verily, Duke, and Stanford to develop a well-defined reference, or “baseline” of health, and the NIH Environmental Influences on Child Health Outcomes (ECHO) program.

Patrick-Lake previously served as director of stakeholder engagement for the Clinical Trials Transformation Initiative (CTTI) and director of patient engagement for the Duke Clinical and Translational Science Institute (CTSI). She also served as co-chair of the advisory committee to the NIH Director for the Precision Medicine Initiative Cohort Program (now All of Us), which was launched in 2015 to create new models of patient-powered research and provide clinicians with new tools and therapies. Recently, Patrick-Lake was named to the National Academies of Science, Engineering, and Medicine Health Science Policy board.