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.
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.
Our philosophy extends to the DCRI Research Together™ program which provides sponsors and investigators with access to DCRI thought leaders who understand the science of engagement. This program is led by Bray Patrick-Lake, MFS, and supported by a team of communicators, clinical project leads, and participant engagement liaisons.
Email DCRI-ResearchTogether@duke.edu or call 919-668-9210 to discuss your research needs and reach the appropriate engagement team.
Guiding Principles of Participant Engagement
Research Together™ means that relationships are bidirectional – everyone learns from each other and everyone gains value. The following principles guide these partnerships to ensure mutually beneficial outcomes:
- People come first. Always.
- We recognize that people are embedded in dynamic family and community frameworks that we honor and respect across the continuum of life care.
- People are our partners in research; not our subjects. We believe in taking every opportunity to co-learn. We engage participants, families, and community members in our research design, conduct, oversight, and dissemination activities.
- We are transparent and trustworthy. We communicate to research participants how valuable their contributions are to science and medicine. We take the time to thank research participants, update them on progress, and share our findings in language understandable to everyone.
- We create value. We work to return results in a responsible and meaningful manner and maximize what can be learned by sharing data with other researchers. We give back.
- We are not transactional in our approach. We encourage and incentivize collaborations with people and communities that look past the end of a project or last study visit. We create opportunities to continue co-learning and working in partnership with participants, families, and community members to improve health outcomes.
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.
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.
Models of Engagement: Patients as Partners in Clinical Research
Clinical trial participants are increasingly moving from passive to active partners in research. In this article, DCRI experts delve into the three different patient partnership models that can help researchers navigate which method of engagement could work best for their clinical program or study.
In ADAPTABLE, the role of the patient has shifted from participant to partner. Adaptors are patient representatives who have been involved in ADAPTABLE from the beginning. Working with the study team, Adaptors helped design the protocol, consent form, study portal, and study materials. Adaptors will be integral in disseminating study updates and results to other patients and in the community. Adaptors participate in investigator meetings, on the Steering Committee, and two Adaptors serve as patient representatives on the Executive Committee.
The CONNECT-HF trial team worked closely with a team of patient advisers, called the Cardi-Yacks, while designing the trial. The Cardi-Yacks are all people living with heart failure, who offered their real-life experiences of living with heart failure to help researchers design a trial that would be both useful for patients and easy to participate in. The Cardi-Yacks gave feedback on the informed consent process, instructions and handouts for patients, patient resources, and more, all with the needs of real-life patients in mind.
Bray Patrick-Lake, MFS
Director, Stakeholder Engagement
Program Director, Research Together™
Bray Patrick-Lake, MFS, serves as director of stakeholder engagement for the DCRI, and program director for Research Together™. She Patrick-Lake 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.
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. CTTI has created recommendations for enhancing participation and engagement of patient groups in medical product development.