Originally published on the JagWire at https://jagwire.augusta.edu/mcg-researchers-awarded-1-9-million-grant-to-expand-inclusion-in-research/

Researchers in the Department of Family and Community Medicine at the Medical College of Georgia at Augusta University have been approved for a $1.9 million funding award from the Patient-Centered Outcomes Research Institute for their study aimed at demonstrating the most effective engagement approach for underrepresented and vulnerable populations in clinical research.

Co-led by Christy J. Ledford, PhD, professor and vice chair of research in the Department of Family and Community Medicine, and Samantha Jones, PhD, assistant professor, the “Co-Creating Novel, Feasible, and Inclusive Research Methods” study challenges assumptions potential participants or volunteers may have about involvement in research.

As Ledford and Jones conducted research on the impact of stress on health in Augusta, they repeatedly encountered participants who saw the importance of the overall topic and wanted to help people like them. But when potential volunteers hear about what exactly they must do as part of the study, they do not volunteer.

The project team wants to change that. This study, designed to help improve the methods of patient-centered comparative clinical effectiveness research, will test if it is possible to increase research participation by creating methods in partnership with the research participants themselves.

“When we’re in the community talking about Dr. Jones’s research on stressors and breast cancer, women are eager to help up until they hear that we’re asking them to come to research appointments at the medical college,” Ledford said. “Women are particularly hesitant to volunteer when they hear about a blood draw. By working with study volunteers to co-design study protocols, we can design studies that are more patient-centered and culturally sensitive.”

These participants are “co-researchers.” Although they are not professional researchers, they work alongside the research team to design the study so that it is directly relevant to the participants and their community.

Co-researchers share control throughout the research process, empowering participants past token participation to shared power. When co-created with study participants, methods will be more trustworthy. The CONFIRM study will test whether creating methods in partnership with the research participants themselves will increase research participation.

Increasing research participation is essential in areas of research like Jones’s work on breast cancer and stress.

“Low participation rates of both racial and ethnic minorities in clinical trials are connected to preventable disparities in cancer treatment outcomes and survival,” explained Jones. “CONFIRM is a first step to advance health equity in cancer research.”

Ledford and Jones’ study was selected through a PCORI Funding Announcement focused on building an evidence base to support development of measures and approaches that strengthen meaningful engagement in comparative clinical effectiveness research.

A lot has been learned in recent years about participatory research that seeks to involve the ultimate end users of study results, including patients, caregivers, clinicians and others, as partners in the research process, but there has been little systematic study about which engagement techniques are most effective.

In recent years, a lot has been learned about participatory research that seeks to involve the ultimate end users of study results as partners in the research process, including patients, caregivers, clinicians and others. However, there has been little systematic study about which engagement techniques are most effective, and this study is focused on building an evidence base to support development of measures and approaches that strengthen meaningful engagement in comparative clinical effectiveness research.

The study will include a Community Expert Council, composed of Augusta residents who bring valuable community insights. Led by Britney Pooser, executive director for the HUB of Community Innovation Augusta, the CEC will meet regularly throughout the study to help make the findings both relevant and meaningful to the broader community.

“This study was selected for PCORI funding for its potential to strengthen patient-centered and stakeholder-driven comparative clinical effectiveness research by providing evidence about specific engagement methods and measures that promote representative engagement of patients and other stakeholders in research,” said PCORI Executive Director Nakela L. Cook, MD. “We look forward to following the study’s progress and working with the Medical College of Georgia to share the results.”

This award has been approved pending the completion of a business and programmatic review by PCORI staff and the issuance of a formal award contract.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions.