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The National Center for Advancing Translational Sciences has awarded $63.7 million in grant funding to the Yale School of Medicine’s Center for Clinical Investigation, money that will support projects ranging from recruiting study participants from communities of color to developing a drug therapy for Type I diabetes.

The grant supports the Yale Center for Clinical Investigation, an organization within the School of Medicine dedicated to supporting translational clinical research and training the next generation of clinical investigators. The YCCI previously received funding from the NCATS through its five-year Clinical and Translational Science Award. This new grant is a renewal of the previous grant.

“The YCCI is a critical resource for our university, not just the medical school,” said John Krystal, co-director of the Yale Center for Clinical Investigation. “That is partly because translational research, taking new approaches in research and applying them to patients in order to develop treatments, has become incredibly more elaborate than it once was and requires enormous infrastructure.”

According to Krystal, the Yale Center for Clinical Investigation fulfills three main functions as a “resource” for the entire University.

First, the YCCI is responsible for conducting research by partnering with Yale New Haven Hospital. The grant also supports the Center’s neuroimaging and genome sequencing laboratories. 

Second, the Center facilitates the regulatory and administrative side of research by providing support for bioinformatics, analysis of clinical data and administrative management for grant applications.

Lastly, YCCI supports career development through grants and research training. For example, pilot grant programs help investigators receive monetary compensation to begin their careers or pivot in a new direction. 

“No one can claim ownership to the grant and say the grant’s supporting their work only,” said Kevan Herold, deputy director of YCCI. 

The entirety of the grant will help maintain the YCCI’s current infrastructures and support the next generation of translational research. Instead of focusing the grant money on a specific project or laboratory, the award will be distributed to maintain the Center’s current projects and support ongoing investigations, according to Herold. 

The YCCI is also unique in its ability to provide support to investigators without corporate intervention. For example, Herold was able to conduct an investigational new drug application for Type I diabetes without the support of a pharmaceutical company because the YCCI provided the necessary infrastructure. The grant money will help maintain these networks, whether administrative or clinical. 

According to Krystal, the grant will help the YCCI continue its work on major health and translational research issues. 

“Translational research has to do with bringing the discoveries of basic science to the bedside,” Herold said. “It has to do with understanding the effects of our treatments on people.” 

Investigators want to learn more about the healthcare system and how data generated from hospitals can change treatment plans. YNHH and the VA Connecticut Healthcare System generate clinical data that can help researchers track the efficacy of certain treatments and monitor hospital patients’ progress.

This data can help meet another YCCI goal: advancing personalized healthcare. According to Krystal, most research only considers a subset of patients that meet a certain criteria for a particular study. However, the average patient is a composite of a wide range of clinical presentations, and each patient is unique. Investigators are interested in considering a variety of factors such as genetics, nutrition or environment when developing a treatment plan for a particular patient. 

As such, investigators at the YCCI want to use data from partner hospitals and new computational approaches like machine learning to better understand individual patients. This is not a specific project, but rather a new enterprise that the grant makes possible, Krystal said. 

The grant money will also support initiatives related to healthcare and patients of color. Historically, many research studies have been focused on white patients, but the YCCI aims to fill this gap through its community-based initiatives, according to Krystal. 

“We want people who are interested not only in figuring out how to develop a new treatment, but also how to better engage BIPOC patients,” Kyrstal said. 

Tesheia Johnson, chief operating officer and deputy director of the YCCI, is a leader of the YCCI’s community-based programs. She spearheaded the Cultural Ambassadors Program, an organization that aims to advance patient diversity and equity in clinical research. 

According to Johnson, the Yale Cultural Ambassadors program began in 2010 after YCCI leadership reached out to community leaders to discuss the lack of diversity within clinical research at Yale. The partnership includes the African Methodist Episcopal Zion Churches of Connecticut, one of the oldest African American congregations in the country, and JUNTA, a Latinx advocacy organization. 

“The group works directly with investigators through a monthly bi-directional forum that provides an opportunity for Yale researchers to present their work and for Cultural Ambassadors to express the needs of their communities, offer input about the design of clinical studies and give advice on recruitment,” Johnson wrote in an email to the News. “Cultural Ambassadors also work with investigators to create culturally sensitive materials and develop other avenues of accessing hard-to-reach populations.”

Local pastors Reverend Elvin Clayton and Reverend Dr. Leroy O. Perry Jr. are two of the Cultural Ambassadors. Through their church communities, they raise awareness about the importance of patient diversity in clinical trials.

According to Johnson, over the past five years, 61 percent of enrolled patients in studies involving the Cultural Ambassadors have been underrepresented minorities. In addition, 97 percent of the underrepresented minorities enrolled in the study remained in it until its completion.

Historically, recruiting and retaining underrepresented minorities in clinical research has been a challenge, she said. The partnership between community leaders and the YCCI has substantially improved these representation and retention issues, according to Johnson.  

The success of the Cultural Ambassadors program led to a Memorandum of Understanding, a formal agreement with the FDA’s Office of Minority Health and Health Equity. According to Johnson, the partnership between the YCCI and the FDA will help develop collaborations, outreach initiatives and educational programs. The NCATS grant will help continue these outreach efforts. 

“Engaging with community leaders is critical for teaching the YCCI, and the Yale medical research community, both about how to communicate more effectively with our surrounding community and how to conduct research that is more meaningful to our surrounding community.” Krystal said. “This gives us the opportunity to disseminate research more broadly while the interest of the participants is nurtured and protected.”

In addition to the NCATS grants, the YCCI also receives support from the Yale School of Medicine.

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