Valuing Patient Perspectives in Clinical Research

Valuing Patient Perspectives in Clinical Research

CONNECT-HF: A Mother With Young Children Wants To Help People Through Diagnosis

One way the DCRI takes into account the important perspectives and voices of women is through Patient Advisory Groups that advise our clinical research projects. The CONNECT-HF project is a nationwide clinical trial for people who are leaving the hospital after receiving treatment for heart failure. The goal of the CONNECT-HF Trial is to help improve care for people with heart failure so that they can live healthier lives and have a better chance of staying out of the hospital.

Early in the development of CONNECT-HF, the research team brought together a patient advisory group to help develop materials and plans for the trial. The group members, who are all people living with heart failure, named themselves the Cardi-Yacks. Two members of the Cardi-Yacks are women, and they bring their own perspectives of living with heart failure to the discussion.

Kirsten, a Cardi-Yack and mom who was diagnosed with heart failure when she was 40 years old, said that she wanted to be a part of the advisory group because she had trouble finding information for people in her situation.

“I was looking for information about how deal with young children and still manage your disease,” Kirsten said. “I’d like to be able to help people get through the experience when they first get diagnosed, because that was a very scary time for me, thinking about possibly dying and leaving my children. I want them to know that there is light at the end of the tunnel.”

To learn more about Kirsten and Fredonia, another woman in the Cardi-Yack group, watch these videos:

AEGIS-II: A Latina Woman Shares What She Learns With Her Community

Another DCRI project that incorporates a patient advisory group to gather diverse perspectives is the AEGIS-II study. AEGIS-II is studying if an investigational drug called CSL112 can help protect people who recently experienced a heart attack from having another one. Maria Ortiz, from San Elizario, Texas, is one of eight total members and one of three women in the AEGIS-II patient advisory group.

Maria, who has had two heart attacks, said she did not get enough information about her condition after her first heart attack. She did not understand the problem with her heart, and said she just got a pacemaker because her doctor told her she needed it. She said that the materials AEGIS-II study is providing to help people understand their heart condition is a big improvement for patients.

“I can help more people like me, and people who are coming behind me who don’t know about their illness,” she said. “By learning every step of research through the advisory committee, I can help my community better understand research and heart problems.”

ADAPTABLE: A Man Uses His Experience to Contribute to Research

In ADAPTABLE, nine patient partners called the Adaptors make up a diverse group of integral team members who are passionate about representing and reflecting the best interests, concerns, and welfare of potential, current, and future clinical research participants. ADAPTABLE is a pragmatic study comparing the effectiveness of two different daily doses (81 mg and 325 mg) of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease.

Tom McCormick, from Columbia, Maryland, got involved in ADAPTABLE after his primary care doctor convinced him that by sharing his experience, he could make a useful contribution to the study. He was instructed to take aspirin after he was diagnosed with angina and went through bypass surgery nine years later.

“I think it is important that patients be involved in medical research because many times, what is important to the doctor is not the same as what is important to the patient,” McCormick said.

McCormick said he enjoys being involved in what he sees as a worthwhile endeavor. He is intrigued by ADAPTABLE’s use of electronic medical records and thinks that the wealth of data included in these records will make it possible to do research and produce results on a wider scale. You can learn more about Tom in this video:

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.

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. 

In the videos below, DCRI Research Together™ experts explore how we are setting the gold standard by making a commitment to participant engagement.

  • Bray
  • Jamie Roberts
  • Kevin Weinfurt and Amy Corneli

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.

Highlights

The Making Of A Patient Advocate

Publication

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

Podcast

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

Publication

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.

Patient Partners

ADAPTABLE’s Adaptors

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.

CONNECT-HF's Cardi-Yacks

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

People

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™. 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.

ctti