ACRP 2024 Expert Panelists Tackle Top Concerns and Opportunities for Better Clinical Trial Conduct

Nobody ever said that clinical research would be easy. Whether the challenge at hand is study start-up, protocol complexity, principal investigator (PI) involvement, community engagement, patient recruitment and retention, or any of a wealth of other factors that go into making a clinical trial’s recipe a hit with its stakeholders, few if any sure-fire combinations of ingredients have proven to work for every audience in every setting.

However, two ACRP 2024 panels on Sunday (May 5) featured some of the most experienced “chefs” of the clinical research enterprise sharing some of their best “secret sauce” wisdom on how progress can be made toward more efficient studies that will serve a more diverse range of patients where they live and work.

In the Signature Series gathering on “Planting a Seed is Not Enough: Nurturing Community Engagement to Grow Patient Recruitment and Retention,” moderator Ashley Moultrie, CCRP, Director for DEI and Community Engagement at Javara, cautioned the audience that “We’re not planting seeds on Saturday and picking fruit on Thursday.” Still, panelists Seneca Harrison, Vice President of Operations and CEO of Quality Research Inc.; Monair McGregor, PhD, MPH, MCHES, Community Engagement Program Manager for SiteBridge Research Inc.; and Christopher Romero, MD/PhD, FACP, DABOM, Regional Medical Director for Headlands Research, offered advice on the topic in the spirit of service and humility.

“I’m blessed to be working in a company that values community engagement so much that it has its own department” for it, said McGregor, who is based in North Carolina. “We have to be sure we are bringing the right message—delivered in the right package—[to audiences of potential trial participants]. …We have to show up and keep on showing up. …Once we have [built a] foundation of trust, so much more can happen.”

“When you do show up [in the communities your sites serve], you have to humble yourself, because you do not understand everything” about the people you are seeing, added Harrison, whose company advances healthcare solutions for residents in the Midwestern U.S. “Sponsor community events, go into low-income neighborhoods, [and] treat them the way you want to be treated.”

Based as a PI with the multistate network of Headlands Research sites in Brownsville, Texas, Romero noted that the relationship between researchers and study volunteers cannot be transactional. “When you [keep showing up], I’ve found in a lot of areas where others have come and gone, you can build trust,” he said. “This is all of our charge—you will find the time for the things you prioritize in life. Making that commitment [to share the benefits of research] tells your [team, board members, and community] what you stand for.”

Immediately after the patient engagement panel, Moultrie was back on stage as a contributor to a session on “NIH Partnering with ACRP to Address Challenges Related to Implementing Trials” alongside Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director for the HEAL Pain Effectiveness Research Network Data Coordinating Resource Center at the University of Utah; Krista Ellis, a Project Manager for the Data Coordinating Center at the same institution; Mary Paulter, Director of Program Services for the Utah center; and Edwina McNeill-Simaan, Program Director at the Vanderbilt University Medical Center, Institute for Medicine and Public Health, and Director of Operations for STAR Clinical Research Network.

This session offered a peek into the findings of a recent survey of nearly 90,000 clinical research professionals conducted on behalf of the National Institutes of Health’s (NIH’s) National Institute of Diabetes and Digestive and Kidney Diseases by ACRP in cooperation with Javara, the University of Utah, Vanderbilt University Medical Center, and Johns Hopkins to identify their opinions on the probable causes of many NIH-funded trials not achieving their enrollment targets within allotted time or budgets. Based on 100 responses, the panelists discussed such concerns as patient recruitment and retention problems, difficult study start-up timelines, low levels of PI engagement and involvement, excessive protocol complexities, and site selection challenges.

Author: Gary Cramer