EHR Provider, Research Group Partner for Increasing Access to Clinical Trials, Diversity
Electronic health record providers NextGen Healthcare and Circuit Clinical are teaming up to help providers connect diverse patient populations to access clinical trials through federally certified medical centers, the companies said Wednesday.
NextGen has 14,000 suppliers and 300 medical center clients, and collaboration with Circuit Clinical, an integrated research organization, will improve clinical trial recruitment. The companies hope this will lead to more treatment options and improved health outcomes for patients of color.
Patients participating in the trials will receive stipends and additional visits at no additional cost, allowing them to spend more time with their doctors, said Srinivas Velamur, director of development and strategy at NextGen Healthcare.
Research and clinical trials can benefit health care providers and quality of care by providing clearer data on treatment effectiveness among patients. During the pandemic, black and Hispanic patients are often underrepresented in COVID-19 vaccine trials.
The lack of diversity in clinical trials has been a well-known problem in the healthcare industry, said Dr. Markus Schabacker, President and CEO of ECRI.
According to the US Food and Drug Administration, racial and ethnic minorities make up about 40% of the US population, but 75% of the 32,000 people who participated in 53 new drug trials in 2020 were white.
According to the American Kidney Foundation, more than one-third of kidney failure patients are black, but black patients make up only 9% of participants in renal failure clinical trials.
Clinical trials designed by drug companies or medical device companies typically end up in a study composed mostly of white males because of the study criteria and the frequent exclusion of women of childbearing age and older people with underlying medical conditions, Schabaker said.
Before participants are recruited by companies such as NextGen, Schabacker suggested that the researchers identify racial and ethnic subgroups to include in their initial study design as another measure to ensure the data is adequately representative of the general population.
“This is really a critical factor to make sure we develop pharmaceuticals and medical devices that are beneficial to all segments of the population,” he said. “In terms of health equity and access to healthcare, this is a very important step.”
NextGen uses datasets from its healthcare systems with information about socioeconomic status or patient demographics to identify participants for Circuit Clinical recruitment, Velamour said.
“Most of these digital research networks today start with de-identified datasets that look like they might fit and try to recruit them, rather than starting with named patients and populations that are recommended by real doctors who take care of them,” said Velamur.
Last month, the Food and Drug Administration released new guidance to help organizations develop a plan to diversify clinical trials by recruiting more participants from underrepresented populations.
The clinical trials partnership also contributes to the NextGen Community Health Collaborative, which offers benchmarking data, benchmarking analytics and reporting services providers, and a forum to discuss best practices in advancing health equity among low-income populations, Velamor said. .
“The long-term goal is to create a comprehensive solution that provides access to research as care for all the communities we serve,” he said.