Decentralized format can help elevate trial inclusivity: Science 37

Ryan Pack, senior director of diversity in clinical trials for Science 37, recently connected with Outsourcing-Pharma to discuss the underrepresentation of certain patient populations in trials, as well as ways that the decentralized format and other technologies can help deal with the challenge.

OSP: Please give us a snapshot of Science 37, its focus, and its unique offering in the industry.​

RP: Since its founding in 2014, Science 37 has pioneered the decentralized model—helping sponsors accelerate clinical research by enabling universal access for patients and providers, anywhere. Our Operating System combines our end-to-end technology platform with expert specialized networks to enable faster enrollment, greater retention, and a more representative patient population.

OSP: Please also tell us a little bit about your background and role.​

RP: I spent my formative years in the Northern California Bay Area and returned to my Kentucky roots for university. I’m the third generation to graduate from Kentucky State University, a historically black college and university (HBCU), where I earned a bachelor’s degree in chemistry. I followed in the footsteps of my grandfather, who was a chemical engineer. I’m proof of the importance of HBCUs in enabling more diverse and representative professionals.

As the latest United Negro College Fund (UNCF) data highlights, approximately 25% of all African American STEM graduates, and around 30% of our nation's black PhDs and doctors, are produced from these institutions. I later earned a master’s degree in public administration, with a specialization in healthcare administration and finance from the University of Kentucky.

I bring more than a decade of clinical research experience from PRA, PPD, and Worldwide Clinical Trials across clinical operations, business development, and strategic commercial leadership roles. I have spent more than 15 years driving diversity and high-priority initiatives across academia, grassroots community organizations, clinical industry task forces, and collaborating with patient advocacy organizations.

I’ve always had a passion for celebrating our differences and ensuring diverse representation in every industry I’ve served. My unique upbringing—along with my family’s direct experience participating in a pivotal clinical trial that helped eradicate a condition—has helped me in my aim to make research more inclusive. This experience drives me to help demonstrate that people of color do exist in the sciences and that Black people can make a difference by enrolling in clinical trials.

My role at Science 37 is to do my part to share this inspiring news, build out our Diversity in Clinical Trials business unit and help our sponsors drive representation in clinical trials; Moreover, it is an immense honor to lead our innovative Diversity in Clinical Trials Foundation, whose sole mission is to steer funding towards programs that promote diversity in clinical studies.

OSP: What factors have accelerated the adoption of decentralized clinical trials in recent years?​

RP: DCT technologies and methodologies are crucial to making research more patient-centric and representative. With COVID-19, the adoption of DCT has increased as regulators, sponsors, patients, and providers adapted and began to more readily embrace technology-enabled solutions to bring research closer to patients. It may have taken the pandemic to further advance patient-centric DCTs, but we know as traditional trial sites are coming back online that these technologies and methodologies are here to stay.

OSP: Why is it important to improve diverse representation in clinical trials—from a clinical perspective, as well as a societal perspective?​

RP: Compounds interact differently with people of different genotypes, and it’s important that we build a better understanding of this by enrolling patient populations that more closely represent real-world populations. With the push towards personalized medicine, we are understanding that the more diversity we have in our data sets, the better able we are to come up with treatments to serve the needs of patients everywhere.

I have seen the effects that the lack of diversity in clinical trial data can have. A close relative of mine, who was taking a prescription drug that lacked representative clinical trial data, suffered a bizarre serious adverse event. Because there wasn’t adequate representation in the trials, the adverse effect was unknown to clinicians and patients alike. It caused a lot of fear and worry, and additional treatment options had to be taken.

It’s not only the right thing to do from a societal perspective but important because of the clinical nuances. More and more regulators are requiring representation in their data sets, so it’s imperative that sponsors address it or face the risk of delays in approval.

OSP: What are the historical barriers impeding access to clinical research for underserved and disadvantaged populations? And how can decentralized clinical trials help remove those barriers?

RP: In the US, the lack of diversity in providers participating in clinical research dates back to slavery, in terms of having a shortfall of trained professionals from different backgrounds. The closure of several African American Historically Black medical colleges and schools also restricted access.

Education is a factor on the patient side, too, where disadvantaged populations are less likely to have an understanding of, or access to, clinical trials. Furthermore, a number of well-publicized scandals from the past, in which clinical studies have taken advantage of disadvantaged populations—such as the infamous birth control trials in Puerto Rico in the 1950s—have created deep-rooted issues of trust among diverse patients.

With the reach that DCTs enable, we can speak directly to patients that otherwise wouldn’t know about what’s happening in trials and offer them access. Removing the educational and geographic barriers will level the playing field, especially when looking at social determinants of health like poverty. People that have access to the internet, or to social media, can now learn about clinical trials in ways that they probably wouldn’t have known before.

By identifying the grassroots community partners and community investigators that have the trust and the partnership, and providing them access, we’re able to start repairing the trust that’s been lost.

OSP: What is driving the growing focus on diversity in the clinical research space at this moment in time? Why now?​

RP: The pandemic put the world on pause and caused us to take note of social equity at a macro level—and, of course, COVID-19 disproportionately affects Black and Brown populations. As a microcosm of this, clinical trials have come to the forefront. Literature about how diversity on all levels can positively impact health outcomes in communities has existed for decades, not to mention the sustainability of companies and organizations with diverse representation at each level.

As the industry understands ways to accelerate clinical development, companies are also understanding that excluding diverse communities is in fact delaying the acceleration of clinical trials. By partnering with these communities, we have a unique opportunity to truly change the game in drug development. And by expanding our patient pool, we can get treatments to market faster, so it’s become more of a priority for organizations.

The FDA recently issued guidance on adopting decentralization to enable greater diversity among clinical trials patient populations at the end of last year. So, it’s really become a steady strong beat of caring about diversity, and that’s helping boost the adoption of more of these DCT technologies and methodologies.

OSP: How will these trends impact population health outcomes in the long term?​

RP: Increasing the diversity of clinical studies can reduce the burden on healthcare. If we can improve trust from the clinical trials stage and patients’ understanding of clinical trials as a viable option as part of a healthcare plan—coupled with doing our part to impact the social determinants of health—the longitudinal impact could be exponential in reducing the burden on an already overtaxed system. We have the ability to combat chronic conditions that have plagued the planet for decades, and the quality-of-life impact could be tremendous if people get additional years with their families.

OSP: What steps and is Science 37 taking to spur greater diversity in clinical research?​

RP: Science 37 is extremely active in tackling these issues. First, we created a dedicated business unit focused on addressing diversity in clinical trials. Second, we launched the industry’s first Diversity in Clinical Trials Foundation to further advance access.

In addition, we are building out our diversity therapeutic network, which is all-encompassing from identifying providers who traditionally have been excluded from participating in clinical research for one reason or another, or who just haven’t been approached. So, we’re looking at those untapped populations and offering them a platform to feel well-supported by our technology, and by the strength and depth of our primary investigators, to help guide them into clinical research.