While clinical trial sites and sponsors often tout the importance of obtaining a diverse set of participants for studies, many still struggle with recruiting and retaining such a patient population. Liz Beatty (LB), chief strategy officer from trial tech firm Inato, recently discussed why diversity benefits various stakeholders, and how to harness advanced technology to achieve that goal.
OSP: Could you please tell us about Inato — who you are, what you do, key services and capabilities, and what sets you apart from the competition?
LB: Inato powers the first global industry marketplace that matches clinical research sites to the right clinical trials and sponsors.
Inato is leveraging rich site insights, a proprietary technology platform, and deep site relationships to reimagine the clinical trial recruitment funnel. Using a data-driven approach, coupled with a high-touch qualification and support process, the Inato Marketplace flips the traditional selection model of sponsors repeatedly tapping the same few sites, and instead provides all research sites the opportunity to search and match for trials based on their qualifications, interests and needs.
The Marketplace also matches trial sponsors that need to fill research gaps or expand access to innovative, investigational medicines with experienced sites and research centers.
OSP: Please tell us what we mean when we talk about “diversity” in clinical trials.
LB: The reality is that diverse patient populations have different responses to certain pharmaceuticals -- and ignoring this poses a significant community and global health risk.
For biopharma companies and clinical research organizations, the majority of clinical trials are dependent on a very small fraction of research sites - just 5% of research sites conduct 70% of trials today. The current way clinical research is conducted -- where sponsors repeatedly keep tapping the same doctors and research sites over and over -- doesn’t work anymore; it’s too slow and expensive, and patient diversity is nearly non-existent.
A critical reason behind this lack of diversity is the inherent difficulty in recruiting enough patients who statistically represent the population that makes up the disease; in short, the demographics of clinical trials don’t represent the demographics of the patient population. As such, regulators have made a series of well-intentioned attempts to rectify the problem
OSP: Why is attaining a diverse patient population important for a study?
LB: The lack of diversity in clinical trials is a serious problem that’s persisted for decades. Black Americans -- who make up 20% of U.S. multiple myeloma patients and are twice as likely to be diagnosed -- have only accounted for 4.5% of participants in multiple myeloma trials since 2003. Asian Americans -- who make up nearly 6% of the U.S. population -- have accounted for less than 2% of U.S.-based trials.
When you don’t factor in diversity when conducting a clinical trial and create an "exclusive" clinical trial environment that's nearly impossible for new sites to penetrate results is harmful to patients in desperate need of access to trial therapies. Furthermore, the continued lack of diversity in clinical trials is compounding long-held enrollment and execution inefficiencies.
OSP: Could you share some of the risks in failing to recruit a diverse body of participants?
LB: This is not only a moral issue -- it’s a scientific imperative. Providers simply cannot properly treat diverse patient populations with new therapeutic offerings if they are unable to access adequate clinical trial data.
OSP: If you have any examples in which insufficient diversity in the patient pool led to negative effects down the road, please feel free to share.
LB: The current COVID-19 pandemic has shone a light on the negative impact that a lack of diversity in the patient pool can cause. Black and Latino people have been three times as likely as white people to become infected with COVID-19 and twice as likely to die. Asian Americans appear to account for fewer cases but have higher rates of death, and eight out of 10 COVID deaths reported in the U.S. have been of people ages 65 and older.
Historically, however, those groups have been less likely to be included in clinical trials despite having potentially different responses to therapies. Given the pressure to produce an effective vaccine quickly during the pandemic, it remains to be seen if that may sideline efforts to ensure diversity in the trial pool.
A marketplace ecosystem is the solution for creating greater visibility across a more diverse population of doctors and patients. Furthermore, by empowering sites to apply to participate in trials that are most aligned with their interests and specific patient demographics, a marketplace ecosystem can allow sites—especially lower profile and untapped ones—to better promote themselves and gain access to a more level playing field.
OSP: What do a trial team’s efforts to diversify typically look like?
LB: A recent study by the Society for Clinical Research Sites (SCRS) found that sites are working closely with sponsors to drive successful recruitment of diverse patient populations. Some key initiatives include:
- 70% of sites partner with sponsors to create study-specific recruitment plans focused on target patient populations
- 70% of sites conduct outreach to minority-based organizations to establish a network of referrals (e.g. churches, community centers, food banks, medical community, patient advocacy and support groups, etc.)
- 80% of sites utilize appropriate media outlets (radio, TV, social media) specifc to the targeted population.
- 70% of sites have bilingual staff that understand the community colloquialisms and apply them in medical discussions
- 80% of sites routinely request translations from sponsors of all subject-facing materials in the predominant languages of their patient population
- 80% of sites offer hours of operation outside of normal business hours and weekend visits
OSP: How does Inato’s clinical trial marketplace work?
LB: The Inato Marketplace flips the traditional site selection model on its head to democratize clinical trials using a unique, data-driven approach - giving all sites an opportunity to search and match for trials based on their qualifications, interests and patient needs. In turn, Inato matches sponsors with experienced clinical sites and research centers who are looking to fill research gaps or expand access to innovative investigational medicines for their patient populations.
Our approach is three-fold:
- Data: We gather rich insights on each site to ensure deep alignment between sponsors and sites. Information collected includes: Organization and team make-up, research performance and recruitment experience by specialty, patient demographics.
- Technology: We enable quality engagement between sponsors and sites via our proprietary platform. For example, sponsors can obtain early insights from a broad range of sites (not just KOLs), receive a competitive assessment of their study, build early engagement to foster highly motivated site partners, and review site profiles. Sites can own and curate their profiles, while self-selecting trials to apply for or let Inato add trials that would be a likely best fit.
- Deep relationships: We ensure engaged, motivated sites through our high-touch qualification and support process. In turn, our in-depth knowledge of each site helps us further identify the ideal match between a sponsor’s trial and site(s).
OSP: How does this approach improve upon previous efforts to achieve a higher level of diversity?
LB: A marketplace ecosystem is the solution for creating greater visibility across a more diverse population of doctors and patients. By matching the most appropriate sites to the most relevant clinical trials, a marketplace model offers the ability to finally flip the broken, traditional approach of sponsors repeatedly tapping the same few doctors and research sites that typically represent primarily white, male patient pools.
Furthermore, by empowering sites to apply to participate in trials that are most aligned with their interests and specific patient demographics, a marketplace ecosystem can allow sites -- especially lower profile and untapped ones -- to better promote themselves and gain access to a more level playing field.