Patients at Cape Fear Valley Health will have an easier time participating in clinical trials thanks to the health system’s new partnership with Javara, a company based in Winston-Salem aiming to make clinical research more accessible.
Javara’s clinical research staff will work alongside Cape Fear Valley Health doctors, physician assistants and other clinicians. Instead of researchers recruiting patients for their clinical trials, Javara staff will assist the health system to identify and enroll qualified patients.
“Our collaboration enables us to deliver advanced care locally while contributing to broader scientific discovery,” said Dr. Samuel Fleishman, Cape Fear Valley Health’s chief medical officer. “We’re excited about what this means for our patients and our community and are proud to be leading the way in bringing equitable, innovative care options to southeastern North Carolina.”
The health system’s oncology, cardiology, neurology, psychiatry, pediatrics, women’s health and family health departments will receive Javara staff. So long as they qualify, any patient will be referred for clinical trials, regardless of insurance, to ensure equal access to the therapies being tested.
While Cape Fear Valley Health previously conducted clinical research, the health system couldn’t consistently offer clinical trials to patients because it lacked the infrastructure.
“Through this partnership, we are driving forward a more inclusive clinical trial landscape — delivering access where it’s needed most in the greater Fayetteville area and strengthening research efforts in oncology and beyond,” Jennifer Byrne, Javara’s founder and CEO, said in a press release.
Clinical trials have historically not been representative of the racial, sex and age makeup of the U.S. population. Black, Indigenous and other people of color make up over 41% of the population, according to data from the U.S. Census Bureau. However, white people made up 75% or more of clinical participants in 33 of the 50 trials analyzed in the U.S. Food and Drug Administration’s 2024 drug trials report, according to a CityView analysis of the report’s data.
Low demographic diversity in clinical trials for the drug Warfarin led to significant dosing errors, according to a 2015 study of the drug’s clinical trials and a 2022 Congressionally mandated study by the National Academies of Sciences, Engineering, and Medicine. When dosed accurately, Warfarin stops blood from clotting to prevent strokes and pulmonary embolisms. When the dosage is too high, Warfarin causes excess bleeding and other negative side effects that can be deadly.
The key to determining the right dose is genetics, and the clinical trials helped create an algorithm that determined the appropriate dose for each patient. However, because many of Warfarin’s early clinical trials were predominantly made up of white participants, the algorithm didn’t account that Black patients’ genetic ancestry required a higher average dosage for the drug to work properly and Asian patients a lower average dose, according to the 2022 study.
By partnering with Cape Fear Valley Health, which has facilities in racially diverse counties like Cumberland and Hoke, Byrne hopes to help ensure clinical trials are better representative and their results can be generalized to the entire population.
“Our region is home to one of the most diverse populations in North Carolina. Clinical trials have historically underrepresented minority and rural populations,” Fleishman said. “We believe it is both a privilege and a responsibility to ensure that our patients — from all backgrounds — have equitable access to the latest in healthcare innovation.”
CityView Reporter Morgan Casey is a corps member with Report for America, a national service program that places journalists into local newsrooms. Morgan’s reporting focuses on health care issues in and around Cumberland County and can be supported through the News Foundation of Greater Fayetteville.