P1938 - Assessing Enrollment Disparities by Demographics in Colorectal Cancer Clinical Trials Across the United States

Wissam Ghusn, MD¹, Tamara Kadi, MD², Johnny Bou Saba, MD³, Elisia Maalouf, MD⁴, Lynn Kobeissi, MD⁵, Marita Salame, MD⁶, Donna Maria Abboud, MD⁷, Marcel Yibirin, MD⁸, Rudy Mrad, MD⁴, Karim Al Annan, MD⁹, Maria A. Espinosa, MD⁴, Sandra Quezada, MD, MS¹⁰, Aline Charabaty, MD^11
1Boston Medical Center, Boston, MA; ²University of Pittsburgh Medical Center, Pittsburgh, PA; ³University of Pittsburgh, Pittsburgh, PA; ⁴Mayo Clinic, Rochester, MN; ⁵American University of Beirut, Beirut, Beyrouth, Lebanon; ⁶Indiana University School of Medicine, Indianapolis, IN; ⁷Mayo Clinic, Miami, FL; ⁸Boston Medical Center, Boston University School of Medicine, Boston, MA; ⁹Mayo Clinic, Hartford, CT; ¹⁰University of Maryland School of Medicine, Baltimore, MD; ¹¹Johns Hopkins University School of Medicine, Washington, DC

Introduction: Colorectal cancer (CRC) remains a leading cause of morbidity and mortality, with disparities in incidence, prevalence and mortality rates among different demographic and racial groups presenting a significant public health concern. This study aims to assess demographic representation in CRC clinical trials conducted in the United States and compare these findings to national epidemiological data.

Methods: We conducted a retrospective review of all clinical trials from ClinicalTrials.gov that included studies involving patients with CRC until March 2024. We had no restriction to specific study types (i.e., not restricted to therapeutic trial). To maintain a focus on the US population and to ensure the demographic relevance of our findings, we excluded trials that included international sites or participants from outside the US. The demographic variables of interest included age, sex, and race/ethnicity of participants, which were compared to national CRC incidence and mortality data from the demographic data reported by the American Cancer Society between 2020-2022.

Results: A total of 345 trials were included involving 181,579 participants. The average age of participants was 55.9 years, with 67.5% aged between 18-65, and only 32.5% older than 65 (Table 1, Figure 1 A). This contrasts with the median age of CRC diagnosis at 66 years for men and 69 for women, suggesting underrepresentation of the elderly in clinical trials. Sex distribution in clinical trials showed a female participation rate of 48.8%, which does not fully reflect the sex-based incidence, with men having about a 30% higher rate of CRC (Figure 1B). Racial distribution within these trials revealed significant imbalances, with White participants constituting 62.8% of trial populations and African Americans 19.6%, despite African Americans bearing a disproportionately higher incidence of 20% and mortality of 40%, compared to White individuals (Figure 1C-D).

Discussion: Our study elucidates considerable disparities in the age and racial representation of CRC clinical trial participants when compared to the demographic patterns observed within the general population. These results are unique as they shed light not only on the racial/ethnic disparities, but also age disparities which is of utmost importance to address. It is critical to rectify these imbalances by implementing recruitment strategies that ensure diverse and representative participation in CRC clinical research.



Disclosures:


Wissam Ghusn, MD¹, Tamara Kadi, MD², Johnny Bou Saba, MD³, Elisia Maalouf, MD⁴, Lynn Kobeissi, MD⁵, Marita Salame, MD⁶, Donna Maria Abboud, MD⁷, Marcel Yibirin, MD⁸, Rudy Mrad, MD⁴, Karim Al Annan, MD⁹, Maria A. Espinosa, MD⁴, Sandra Quezada, MD, MS¹⁰, Aline Charabaty, MD¹¹. P1938 - Assessing Enrollment Disparities by Demographics in Colorectal Cancer Clinical Trials Across the United States, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.