Health2047 to Improve Clinical Trial Access with New Venture

Health2047, a subsidiary of the American Medical Association (AMA), recently spun out SiteBridge Research to boost clinical trial access for small and community physician practices. 

SiteBridge is a portfolio company that aims to create a path towards enriched real-world data and real-world evidence, which ultimately results in more widely applicable clinical trial results. 

Additionally, SiteBridge is developing a network of leaders, including physicians and experts engaged with pharmaceuticals. The company will gather these industry perspectives to shape research study design and target more diverse patient representation in clinical trials. 

“We’re excited by SiteBridge Research’s mission to democratize clinical trials by opening access and removing barriers to different parts of the clinical trial ecosystem,” Lawrence K. Cohen, CEO of Health2047, said in the announcement. “This involves enabling trials to occur at point-of-care vs. traditional large academic institutions.” 

SiteBridge increases trial access by empowering more physicians and their patients to take part in research through its ‘Trial-In-A-Box’ platform. This approach will help accelerate time to market and product adoption in harder-to-reach communities that have unmet needs. 

‘Trial-In-A-Box’ facilitates research through the application of technology, processes, and functional expertise. The platform provides access to clinical research training, resources and support, and site start-up help. 

Additionally, the platform will help physicians focus on better supporting their patients. 

“As health systems vow to improve health outcomes by tackling social determinants and inequities, it’s critical to ensure clinical trials represent the broadest possible patient set,” said Chris Komelasky, CEO of SiteBridge. 

“Our platform facilitates the participation of smaller physician practices in trials, so research studies can have more representative patient populations for the intended applications of the drugs being tested and create more realistic risk/benefit profiles for new treatments. It puts the focus of research on the trusted relationship between a physician and patient,” Komelasky continued. 

Health2047 is an organization that is working to transform the US healthcare system by spinning out several transformative healthcare companies annually. 

Portfolio companies previously spun out by Health2047 include Emergence Healthcare Group, Phenomix Sciences, Medcurio, Zing Health, First Mile Care, and Akiri. 

According to FDA findings, about three percent of US physicians and patients take part in research today, with most clinical trials conducted in academic healthcare systems that include mainly urban populations.

More often than not, clinical trials do not include medically underserved populations. And minority populations take part in trials at rates less than half of their representation in the broader population.

Lack of trial diversity can be attributed to many factors. 

For example, study participants may be too far away from a study center or physician practices may lack underlying support systems, training, and resources required to function as a clinical trial site. 

Therefore, in mid-November, FDA issued final guidance to encourage clinical trial diversity from the design to execution of the tests.

The guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, now addresses both demographic characteristics of study populations, including sex, race, ethnicity, age, and location of residency, as well as non-demographic characteristics, such as comorbid conditions or disabilities.

FDA first issued the guidance as a draft in 2019. Now, it provides the agency’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches. 

But a March 2021 JAMA Network Open study found that racial and ethnic diversity in clinical trials is lacking despite FDA recommendations.

Overall, white individuals were overrepresented in clinical trials at 77.9 percent of the time. And in the same trials, Black or African American individuals were represented just 10.6 percent of the time.

Additionally, Hispanic or Latino participants were represented just 11.6 percent of the time.