As it has been made evident in the last few years during the COVID-19 pandemic, bodies can experience illness and disease differently. Most commonly, the youngest, oldest, and immune-repressed are noted as the most vulnerable populations. However, age cannot be viewed as a sole indicator of health.
The National Institute for Health launched the National Institute on Minority Health and Health Disparities initiative in 2011 to further educate individuals on the importance of diversity and representation in clinical research. NIMHD notes that factors such as age, biological sex, race/ethnicity, sexual orientation, and socioeconomic status may influence reactions to illness as well as treatment options and drug effectiveness. By including a more diverse population in clinical research, increased insight into the epidemiology of diseases across a community or region could advance healthcare treatment options, increase drug effectiveness, and reduce health disparities.
An observational study published by FDA affiliate researchers in 2021 on Racial and Ethnic Differences in Drug Disposition states, “Understanding the underlying mechanisms that lead to such differences and adequate enrollment of racial and ethnic subgroups is essential to obtain sufficient information on exposure and response.” The FDA’s 2009 Report to Congress listed a variety of barriers to clinical trial enrollment that likely remain valid obstacles today including:
- “lack of understanding about the main obstacles to participation of different age, racial, and ethnic groups in clinical research; […]
- lack of understanding about differences in disease etiology and pathophysiology may lead to under-diagnosis and under-referral of specific demographic subgroups; […]
- language, cultural, and health literacy differences between investigators and patients;
- lack of diverse investigators in studies who may have access to a more diverse patient pool to recruit subjects; […]
- trial logistics (e.g., transportation, childcare) may disproportionately affect specific age, racial and ethnic groups’ ability to complete study follow-up visits […]”
While all of these barriers are important to both recognize and address, the report fails to capture the undeniable issue sites are experiencing with diverse enrollment using traditional recruitment methods, such as external marketing campaigns and manual patient chart review.
Innovative Recruitment Methods to Increase Diverse Enrollment
As industry continues to push for the prioritization of diversity in clinical trial enrollment, new ideas, processes, and tools are required to further support this expanding initiative, particularly in trial recruitment. While this diversity initiative has been active for over a decade, a recent Diversity in Clinical Trial Participation white paper states that, “although over 40% of the US population is currently comprised of ethnic and racial minorities, quite often only 5 to 10% of clinical trial participants represent any minority population.” More specifically and alternately cited, out of the 20,692 trials considered for analysis within “Race/ethnicity reporting and representation in US clinical trials: A cohort study”, an article published within The Lancet Regional Health – Americas, clinical trial participation throughout the United States has shown to be overrepresented by White individuals by 17.7% and underrepresented by Hispanic individuals by 10.9%, Asian individuals by 4.2%, and Black individuals by 2.6% when compared to national race/ethnicity demographics of the United States. Furthermore, the representation of non-White individuals only amounted to 20.3% of overall participants.
In a recent case study analyzing diversity outcomes of 15 clinical trials conducted by a site network located within the Dallas-Fort Worth metroplex, minority representation in study participation exceeded national participation5 amongst Hispanics by 23.9% and amongst Asians by 3%. Representation of non-White individuals amounted to 43.7% of all participants, exceeding national performance by 23.4%. This can largely be attributed to this site network’s utilization of innovative trial recruitment technology, as it was able to leverage its partnerships with local community practices through the use of Aspen Forge. This machine learning software addresses the key challenges sites experience when recruiting qualified candidates for research studies. It provides clinical staff the ability to identify likely candidates by searching de-identified patient clinical text directly from their partner practices’ EMRs and more efficiently reviews clinical records for qualification review.
The improved diversity outcomes experienced by this site can be further illustrated by comparing national diversity observations in clinical research to that of the site network’s surrounding area. When comparing the race/ethnicity of these study participants to that of DFW metroplex demographics, improvements were observed in underrepresentation of minority populations as compared to the before mentioned national deviations. Overrepresentation of Whites beat national deviations by 4.7%, underrepresentation of Hispanic individuals beat national deviations by 9.9%, and underrepresentation of Asian individuals beat national deviations by 1.2%.
Additional factors to consider in the improvement of diversity seen in trials conducted by this site network are its site locations, staff diversity, travel accommodations, language accommodations, and diverse practice partnerships. While these initiatives help, the industry is in many cases already operating in such a way with only a small dent in the diversity issue being observed. The newly introduced variable that is unquestionably improving diversity in trial participation is the use of innovative technologies, such as the one used in this instance, Aspen Forge. Diversity no longer has to be limited by the traditional recruitment method barriers of clinical staff’s capacity to review charts and patient self-identification of candidacy.
 U.S. Department of Health and Human Services. (2022, February 7). Diversity and inclusion in clinical trials. National Institute of Minority Health and Health Disparities. Retrieved August 20, 2022, from https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html
 L;, R. A. K. H. H. S.-W. E. Z. (n.d.). Racial and ethnic differences in drug disposition and response: Review of New Molecular Entities approved between 2014 and 2019. Journal of clinical pharmacology. Retrieved August 20, 2022, from https://pubmed.ncbi.nlm.nih.gov/34608640/
 U.S. Food and Drug Administration. (2017, September 9). Evaluation and reporting of age-, race-, and ethnicity-specific data in … Retrieved August 20, 2022, from https://www.fda.gov/media/98686/download
 Palumbo, P., Hong, P., O’Brien, S., Poopat, C., Toal, C., Andrews, M., & Sanchez, H. (2022, February). Diversity in Clinical Trials Participation: A Life Sciences Perspective. Retrieved August 20, 2022, from https://trinitylifesciences.com/wp-content/uploads/2022/05/Trinity-Whitepaper-Diversity-in-Clinical-Trials-Participation.pdf
 Turner, B. E., Steinberg, J. R., Weeks, B. T., Rodriguez, F., & Cullen, M. R. (2022). Race/ethnicity reporting and representation in US clinical trials: A cohort study. The Lancet Regional Health – Americas, 11, 100252. https://doi.org/10.1016/j.lana.2022.100252