Yale Shows a Path Forward for Research

Aug 18, 2020 | BioNTech, Blog, BNT162, COVID-19, Diversity, News, Patient Recruitment, Pfizer, Vaccine, Yale

Yale Shows a Path Forward for Research

New Haven, Connecticut, like many American cities, represents a multiplicity of reality exemplifying economic, social, cultural, and demographic diversity—that can manifest in chasms between those that secure access to the finer material things in life on the one hand, and on the other many facing an uphill struggle against poverty and institutional friction and its corresponding toll, including health inequities. While one of the Ivy League elites crank out future American leaders, in other parts of the city youngsters learn how to survive in different ways, unfortunately not always legal. At one point one of the most dangerous cities in the United States, times have improved for New Haven overall but progress for all remains an important imperative. The social determinants of health, those factors other than direct physical health that impact one’s well being, are important to consider in the fight against COVID-19 here and everywhere else. Truly important, however, for this small city of about 130,000: a majority of New Haven’s population is “minority” (35% African American and 30% Hispanic). It’s well- known that in Connecticut (as is elsewhere), ethnic minorities, as well as others with various comorbidities and the elderly, die at higher rates due to COVID-19. That research becomes a driver for health care in the age of COVID-19 is an understatement. Yet it must not be directed by the “Deities of Mt. Olympus” but rather from a dynamic, diverse and integrated collaborative, representing the university, the clinic, and the community. The third oldest institution of higher learning in the United States (founded 1701) in some ways demonstrates a way to make research successful as the academic health system understands it must connect, engage, and partner with marginalized communities to reinforce ensuring bridges between academia, clinic, and community. This can lead to greater research participation and over time, more health equity.

The Problem

Marginalized communities, whether it be communities of color or social and economically disadvantaged White populations are disproportionately impacted by the COVID-19 pandemic for myriad factors and forces that won’t be explained in this brief article. But suffice to say—the toll of American health inequity has been fully on display for the world to see. The epicenter of this pandemic (although Brazil is catching up), the U.S. has recorded 5.6 million cases and 173,761 deaths.

And when other ailments are factored in, the death toll from a myriad of diseases, as manifest in average life expectancy by demographic, reveals a world for many in America discernible by illness, pain, suffering and a premature death. Although the social determinants of health aren’t systematically factored into holistic care yet (nor systematically financed), this will change. The costs of the American healthcare system, as TrialSite has expounded, given 70 million or so are on Medicaid alone, have already triggered social, government and market forces to drive down health care costs while improving individual and population health improvements.

With a more imminent problem of COVID-19, the imperative for accelerated vaccine research directs full participation in clinical trials. Yet it’s well established that the very populations that are most at risk, and hence could benefit the most from a safe and effective vaccine, don’t participate in clinical research at nearly the levels required. Trust is probably the number one factor that inhibits community research participation and Yale, among other academic health systems, embraces a myriad of approaches to stimulate greater research participation.

Yale Shows a Way

Although branded by some as an elite, “Ivy League” hub of privilege—and recently picked on by the Department of Justice for allegations of a form of reverse discrimination—Yale actually embarks on deep community integration across the predominantly Hispanic and Black New Haven, offering social, cultural and economic opportunity and, most recently, this dynamic manifests in the academic health systems’ fight against COVID-19. Although the pathogen’s impact has slowed in the northeast, it took a toll disproportionally on communities of color, elderly and other disadvantaged demographics, and Yale has revved up the “cultural ambassador” program to contribute a safe and effective vaccine for all. But first, an important point on the tripartite of care.

It Starts with the Tripartite of Health

The importance of the tripartite of health cannot be overemphasized. An artificial division or barrier between the academic institution, research apparatus and the clinic  (whether hospital or community clinic) represents an absolute prerequisite for medical progress. Here in New Haven, this manifests in the coming together of the university medical school, university clinical investigators (and team) and the community clinic—represented by Yale School of MedicineYale Center for Clinical Investigation (YCCI) and Yale New Haven Health (hospital/clinic). This critically important synthesis, when combined with strong and sustainable bridges to the community, can continuously reinforce the identification, embrace and integration of at-risk populations into the nexus that is Yale, and vice versa. The results benefit the entire community.

The Yale Cultural Ambassador Program

Recently, Yale News reminded the world about the YCCI Cultural Ambassadors program and the role it plays in educating the public on clinical trials. A decade ago, researchers at Yale recognized that they didn’t operate in a bubble, or for that matter Mt. Olympus. Rather, they understood that important medical progress requires ever broadening community participation. But how could that occur, with wide chasms, such mistrust? Actually, Yale figured out it was a relatively easy, and common sense answer! They integrated the research into the community, leveraging the academic health system and other programs already making a difference.

Hence, YCCI partnered up with Junta for Progressive Action and the African Methodist Episcopal Zion (AME Zion) Church to not only arrange for good publicity but to actually strive to ensure that clinical trial participation reflects the diversity of the actual city’s population and that the whole population benefits from research breakthroughs. By embracing a partnership with the oldest Latino community organization in the city and a prominent Black church, Yale reports “great success in engaging populations of color in clinical research.”

Rev. Elvin Clayton, pastor with Walter Memorial AME Zion Church, was quoted “When we started talking about clinical trials in our community, people of color represented only 3%-6% of the participants in clinical trials.” The pastor reports now that that figure is “between 30%-50% participation, and in some trials, over 90%.”

Diverse Participation COVID-19 Vaccine Trials

The federal government, via the National Institutes of Health (NIH) and its infectious disease arm National Institute of Allergy and Infectious Diseases (NIAID) have been on record, strongly, that COVID-19 vaccine trials need to include participation from all demographic segments of America. Prominently in the news, however, is that this goal of greater clinical trial participant diversity continues to be an elusive achievement. 

The metrics shared by the pastor Elvin Clayton are monumental and unprecedented in many parts of the nation. TrialSite doesn’t have the hard data to substantiate the claims but there is confidence that Yale takes its responsibility in the community very seriously.

Yale Joints ‘Project Lightspeed’

Yale School of Medicine and Yale New Haven Hospital recently announced the start of Phase 3 of the “Project Lightspeed”-based study investigating the safety and efficacy of Germany’s BioNTech and partner Pfizer’s BNT162 investigational vaccine for COVID-19. The pivotal study represents a vaccine program that is deemed by many experts as one of the top COVID-19 vaccine candidates. The two individual vaccine candidates under investigation include BNT162b1 and BNT162b2.

A modified RNA based vaccine, the research drives a novel way to create a vaccine for use in people. This method parts with traditional vaccines which use part or whole of the actual virus in an inactive form to trigger immunity. Rather, Yale News offers that the Pfizer/BioNTech candidate “uses a genetic code (modified RNA)to make the body generate proteins that resemble the SARS-CoV-2 virus spike protein, thereby causing  development of antibodies against it.” The BNT162 program has thus far proven to be safe and effective in Phase 1 and 2 clinical trials. But now the big test: Phase 3 with 30,000 participants.

Yale Point of View

Dr. Onyema E. Ogbuagu went to undergraduate school in Nigeria and came to the U.S. to complete medical school, doing his residency at Mount Sinai School of Medicine and Fellowship at Yale School of Medicine. An infectious disease expert and key opinion leader, Dr. Ogbuagu serves the Phase 3 trial as a Yale Principal Investigator and recently commented for Yale News, “I am very excited that Yale New Haven Hospital and the Yale Center for Clinical Investigation (YCCI) are undertaking this novel vaccine trial.” Dr. Ogbuagu is encouraged by the Phase 1 and 2 results.

Emphasizing the importance of what TrialSite coined the “tripartite of health,” Dr. Thomas Balcezak serves Yale New Have Health as executive vice president and chief financial officer and commented on the importance of academic medical centers and how by bringing together academia, research and the clinic brings “cutting-edge care and therapeutics to our community.”

About YCCI

Since 2004, Yale School of Medicine embarked on a strategic evolution to progress clinical and translational research. Nearly two decades ago, two primary goals brought force to a movement to transform research, including 1) centralize the training of the next generation of clinical and translational scientists, and 2) provide robust infrastructure to support innovative collaborative research directed at improving patient care. Hence the genesis of what became the Yale Center for Clinical Investigation or YCCI. Actually launched in 2005, by 2006 the Yale team made such progress that they became the only center in New England and among 12 academic medical centers across the nation, to receive CTSAs. These grants contributed to the Roadmap for Medical Research, an effort to streamline translational research.  Fast forward to 2020 and there are 62 CTSA hubs that constitute a national forum funded by the National Center for Advancing Translational Sciences (NCATS), all of course part of the NIH.

YCCI transformed into an administrative hub for CTSA and a nexus for clinical and translational research at Yale. What has YCCI been able to accomplish?

The YCCI Scholars program for junior faculty members (training and support for 151 outstanding young researchers)—this has led to the publishing of 4,900 papers

·         Over $490 million of independent grant funding

·         Office of Research offers advanced research services  (1,500 services per year to 600 faculty conducting clinical trials)

·         Support of 900 faculty members

·         Support of research across Yale in the form of grants

·         Community outreach (Cultural Ambassador Program, etc.)

·         Numerous other relevant services, initiatives and programs

Lead Research/Investigator

Dr. Onyema E. Ogbuagu, YNHH Infectious Disease physician, Associate Professor of Medicine, Yale School of Medicine

Call to Action: If you are interested in diversifying your clinical trial participation, reach out to the Yale Cultural Ambassador Program—study what they have done and identify the best practices that can be replicated in other communities and academic health systems. The program’s point of contact is Brittany Harris at 203-785-2504 or brittany.harris@yale.edu. Interested in participating in a Yale clinical trial? Follow the link

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