Reflections on the Latest Report by the National Academies on Improving Clinical Trial and Research Representation 

Sudip Bhandari, PhD (Data Scientist) Warren Whyte, PhD (VP, RWE Sciences, ERACE Lead), and Jeff Elton, PhD (CEO) 

The latest report by the National Academies on “Improving Representation in Clinical Trials and Research” report is one of the most comprehensive, authoritative, and passionate statements by the country’s leading scientists advocating for equity as the central pillar of clinical research. It’s a landmark report for a few reasons. First, the report provides one of the few integrated views of the shortcomings and interplays of the current research system from Institutional Review Boards to alternative funding sources that have underpinned the currently limited minority participation. Second, it advances practical approaches and case examples of successes that can improve diversity and inclusiveness in research. These examples span the non-quantitative and highly important tacit approaches of building meaningful relationships with study participants to the more direct need for expanded budgets for teams recruiting more diverse participants. Lastly, the report emphasizes a coherent set of actions such as transparency in progress reports and active implementation of existing policies with minority recruitment requirements, among others. 

We see the report as an important inflection point where trial and study equity considerations move from being an additional goal layered over the legacy process and studies, towards the formalization of a new foundation for how research questions are formed, sites and institutions are selected, and research results presented. We started the journey in health equity and study subject diversity with our ERACE (Engaging Research to Achieve Cancer Care Equity) initiative in 2020 to better understand cancer disparities and create innovative solutions to eliminate them. Today, we infuse equity and diversity as an integral part of our work, built into all our data and technology solutions. With every new research project, technology, and partnership, we’re incorporating equitable and representative research at our very foundation. 

We do believe the report and its authors miss some of the more contemporary approaches that are advancing and accelerating the goals of studying diversity and equity. Not that these are at odds with the report’s intent or conclusions. However, these Real-World Data (RWD) and technology-enabled approaches make them more integral to both healthcare providers and biopharma innovators, the report’s goals, and the “paradigm shift” called for in the report.  

Specifically, our work in three critical areas demonstrates how RWD can aid the mission of disparity elimination in clinical trials: 

Use of RWD in research about clinical trial representation: 

• We have evaluated the impact of performance status criteria on minority eligibility for oncology clinical trials, concluding that improving diversity will require more than just relaxing a single criterion, that a multi-faceted approach is needed. 
• Using our Clinical Trial Optimization AI SaaS solution we have demonstrated how our integrated and large-scale real-world data sources with AI SaaS technologies can lead to a substantial improvement in the enrollment of African American men in prostate cancer trials. 

Use of RWD in the development of AI solutions to improve clinical trials diversity:

• We have developed a validated software solution, Cohort Optimizer (CO) using Real-World Data (RWD) and Artificial Intelligence (AI) to modify criteria to improve the racial and ethnic diversity of a clinical trial cohort. 
• ConcertAI has demonstrated new technologies that provide end-to-end clinical trial support, identifying non-traditional sites and assuring ethnic and racial representativeness of both the trial design and the likely performance of research sites. Our technology suite is the first complete real-world evidence-generation system that aligns retrospective and prospective approaches into a single system. 
• ConcertAI has developed an AI SaaS Digital Trial Solutions that digitizes study protocols and automatically finds eligible patients within our large network of digitally enabled study sites. This solution is deployed with the latest edge computing technologies and integrates multiple algorithmic approaches and enrichments to increase the confidence in patient matching to trials. Continuously learning automated intelligence algorithms reduces the chance of any patients being missed—especially minority patients who may be historically underrepresented in trials.

Use Real-World Data-driven implementing solutions for minority enrollment in clinical trials: 

• We have demonstrated that RWD can be leveraged to identify clinical trial sites with a high potential for Black patient recruitment, thereby addressing a known health disparity problem within multiple myeloma (MM) clinical trials. 
• We have engaged with the leading biopharma innovators, medical societies, the US Food and Drug Administration (FDA), and pharma partners to advance innovative insights that inform clinical trial study designs at a pace not possible through legacy approaches. 

The report from National Academies on improving clinical trial and research representation squarely aligns with ConcertAI’s mission, culture, and actions. Over the course of the last three years, we have demonstrated and actively published on the critical role of RWD and advanced AI technologies to enhance diversity in clinical trials. Without these data and solutions, we are unable to truly understand the current state; derive the current standard of care outcomes across settings and groups; nor define ‘equitable’ from an epidemiological and statistical baseline. Given the increase in the cost and time of diversifying trials, we believe that RWD and RWD-enabled AI technologies can aid in cost-efficiency and will be the enablers for the National Academies’ recommendations in creating a more transformative and equitable future.