May 22, 2022 – The drive to diversify clinical trials most definitely has intensified. With a confluence of factors, from precision therapies needing investigational representation to ethical and moral factors, the business of testing new medicines on a representative population has evolved past the nice-to-have concept to mission-critical. The Society for Clinical Research Sites held a compelling two-day conference in downtown Austin titled SCRS Diversity Site Solutions on Friday, May 20th, and the Global Oncology Site Solutions Summit on Saturday, May 21. TrialSite attended the diversity event on Friday and was truly impressed with the turnout and presence of trial site organizations from across North America, as well as sponsors representing the largest pharmaceutical companies and contract research organizations (CROs)–all there to not only discuss why diversity in medical diversity is important but to showcase exactly how they were going to make this a new reality.
Kicking the program off was the charismatic yet sincerely down-to-earth Jerome Adams, MD, MPH, an American anesthesiologist and former vice admiral in the U.S Public Health Service Commissioned Corps who served as the 20th Surgeon General of the United States under Donald J. Trump. Also speaking was Lorena Kuri, head of Bristol Myers Squibb Diversity Strategy and prominent pharmaceutical industry influencer for diversity practices. Joining the two prominent speakers was Diana Foster, PhD, a consultant for SCRS as the Vice President of Strategy and Special Projects.
TrialSite’s founder Daniel O’Connor visited the event and was impressed with how much SCRS has grown—a force representing trial site organizations all over North America. The influence of the SCRS, representing the trial site (mostly commercial research centers but also open to hospitals, clinics, and health systems as well as academic medical centers), undoubtedly grows.
With advancements in precision therapy comes the need to ensure such novel therapies are evaluated on a diverse array of the population. For too long, advanced research involving state-of-the-art novel treatments ends up benefiting upper- and middle-class white males whereas ethnic and racial minorities, including Blacks, Hispanics, and Asians, as well as other underrepresented populations such as lower-income rural whites, haven’t been on the research agenda.
That’s changing big time. The SCRS conference made it quite clear that the biggest pharmaceutical companies, from AbbVie, and GlaxoSmithKline to Bristol Myers Squibb, Janssen, Pfizer, and Sanofi and Lilly, are investing significantly in research minority populations. Moreover, they are in business to work with trial sites to ensure that diversity targets in research are met.
In fact, TrialSite’s O’Connor learned at this event that Pfizer partnered with the national trial site organization Headlands Research to build from the ground up trial site locations in minority communities. The first joint project is scheduled for Brownsville, Texas, on the Mexico border.
Companies such as Sanofi shared with TrialSite their strategies for including diversity in research. In the case of the French giant, they start at the trial design level, including that patient profiles and population health considerations get factored into all new protocols. They are on the lookout for trial sites that can accommodate their mandates.
Similarly, GlaxoSmithKline employs a data-driven approach to better understand the dynamics of the investigational product, disease target population health dynamics, and location in their quest to ensure representation on parity to national percentage—for example, the UK-based pharmaceutical giant seeks to recruit at least 12% of African Americans in their studies based on the national population.
Ellen Morrison, a Strategic Account Lead in the Janssen Research & Development Oncology group, shared that the company is taking a methodical, community-based approach to ramp up new trial sites in minority areas. The subsidiary of Johnson and Johnson also expressed an openness in expanding beyond its comfort zone to reach out and connect with new trial site organizations.
Trial Sites that Practice what they Preach
Influential participants such as Fabian Sandoval secured attention from all participants, declaring that initiatives targeting minority populations need to be sincere and not merely a reaction or an industry fad. Sandoval has built up Emerson Clinical Research Institute, a trial site organization based in the Washington DC area.
Sandoval believes that pursuing research makes doctors better physicians. He has been driven by research for many years and has specialized in working with minority communities. While Hispanics represent 16% of the U.S. population, only 1% are represented in clinical trials. Sandoval also shares that African Americans, representing 12% of the population, represent only 5% of clinical trial participants.
At Emerson Clinical Research Institute, they provide minorities a voice to be in clinical research studies. Emerson has organized an award-winning television show highlighting the importance of research in Hispanic communities.
TrialSite’s O’Connor spoke with Dr. Sandoval, who expressed his interest in connecting with even more minority patients in the Washington DC metro area. Sandoval emphasizes the critical importance of patient engagement. While he acknowledged that most drugs work the same for everyone, he shared with the TrialSite News founder that with the advent of precision therapy comes some therapies that might behave differently in different persons from different racial and ethnic backgrounds. Sandoval shared it’s pivotal to get research representing the population at large. But he noted that most often, sponsors don’t include outreach funds for minority communities. This is unfortunate and should change.
SCRS Growth
Overall, the Society for Clinical Research Sites (SCRS) has come a long way since its visionary founder, Christine Pierre, passed away while the organization was still in its formative stage. While this association representing trial sites across North America slowed down after Pierre’s unfortunate passing, they have picked up speed in what’s become a white-hot trial site ecosystem.
TrialSite suggests any organization either running clinical trials or supplying products and services to support that endeavor consider signing up for an SCRS membership.
About SCRS
The Society for Clinical Research Sites (SCRS) was founded in 2012 in response to the growing need for a global organization representative of the needs of clinical research sites. SCRS currently represents over 9,500 research sites in 47 countries. SCRS is an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise.
SCRS founder Christine Pierre described the founding principle of the organization: “We are all aware that as an industry, we currently have an unsustainable model – for all stakeholders. Sites represent the largest number of providers to the industry; therefore, their impact on this process cannot be underestimated. Sites have long been the silent partner in the research enterprise, and SCRS ensures they are no longer passive participants by catalyzing dialogue with industry leaders and working to find solutions through collaboration.”
The drive to diversify clinical trials most definitely has intensified. With a confluence of factors, from precision therapies needing investigational representation to ethical and moral factors, the business of testing new medicines on a representative population has evolved past the nice-to-have concept to mission-critical. The Society for Clinical Research Sites held a compelling two-day conference in downtown Austin titled SCRS Diversity Site Solutions on Friday, May 20th, and the Global Oncology Site Solutions Summit on Saturday, May 21. TrialSite attended the diversity event on Friday and was truly impressed with the turnout and presence of trial site organizations from across North America, as well as sponsors representing the largest pharmaceutical companies and contract research organizations (CROs)–all there to not only discuss why diversity in medical diversity is important but to showcase exactly how they were going to make this a new reality.
Kicking the program off was the charismatic yet sincerely down-to-earth Jerome Adams, MD, MPH, an American anesthesiologist and former vice admiral in the U.S Public Health Service Commissioned Corps who served as the 20th Surgeon General of the United States under Donald J. Trump. Also speaking was Lorena Kuri, head of Bristol Myers Squibb Diversity Strategy and prominent pharmaceutical industry influencer for diversity practices. Joining the two prominent speakers was Diana Foster, PhD, a consultant for SCRS as the Vice President of Strategy and Special Projects.
