eP556 - Sex, Ethnic, and Racial Representation in Clinical Trials for Inflammatory Bowel Disease

Author(s)

• SA

  Sarfraz R. Akmal, n/a

  Medical Student
  Rutgers - Robert Wood Johnson Medical School
  New Brunswick, New Jersey, United States

  Disclosure information not submitted.

ePoster Presenter(s)

• 

  Sorasicha Nithikasem, BS (she/her/hers)

  Medical Student
  Rutgers Robert Wood Johnson Medical School
  Piscataway, NJ, United States

  All of the relevant financial relationships listed below have been mitigated.
  This individual has no financial relationships with ineligible companies.

Author(s)

• 

  Kayla N. Laraia

  Medical Student
  Rutgers - Robert Wood Johnson Medical School
  New Brunswick, NJ, United States

  All of the relevant financial relationships listed below have been mitigated.
  This individual has no financial relationships with ineligible companies.
• SG

  Stephanie N. Gregory, MD

  General Surgery Resident
  Rutgers RWJMS
  New Brunswick, New Jersey, United States

  Disclosure information not submitted.
• 

  Alexander J. Rossi, MD

  General Surgery Resident
  Rutgers Robert Wood Johnson Medical School
  Rutgers Robert Wood Johnson Medical School
  New Brunswick, NJ, United States

  All of the relevant financial relationships listed below have been mitigated.
  This individual has no financial relationships with ineligible companies.
• SP

  Shruthi R. Perati, M.D.

  Surgical Resident
  Rutgers Robert Wood Johnson
  New Brunswick, New Jersey, United States

  Disclosure information not submitted.
• DF

  Daniel Feingold, MD

  Professor of Surgery
  Rutgers University
  New Brunswick, New Jersey, United States

  All relevant financial disclosures have been managed and will be listed below.
  This individual has no financial relationships with ineligible companies.
• NM

  Nell Maloney Patel, M.D.

  Program Director, General Surgery Residency
  Rutgers - Robert Wood Johnson Medical School
  New Brunswick, New Jersey, United States

  Disclosure information not submitted.

Senior Author(s)

• KD

  Kristen Donohue, MD

  Assistant Professor of Surgery
  Rutgers RWJMS
  New Brunswick, New Jersey, United States

  Disclosure information not submitted.

Purpose/Background: Females, racial groups, and ethnic minorities are often underrepresented in clinical trials, which may affect the external validity of these studies, as well as reflect the underlying systemic disparities that exist in clinical research. Our objective was to quantify representation of these groups in clinical trials for inflammatory bowel disease (Crohn’s disease and ulcerative colitis), given that this disease disproportionately affects women as well as racial, ethnic, and low socioeconomic status populations.Methods/Interventions: The ClincialTrials.gov database was queried for completed interventional phase II/III trials from 2010-2020 within the United States for patients with inflammatory bowel disease, defined as Crohn’s disease and ulcerative colitis. The national prevalence of inflammatory bowel disease among sex, racial, and ethnic groups was extracted from the CDC National Health Interview Survey conducted in 2015. Representation quotients (RQ) were calculated by dividing the proportion of each sex, racial, and ethnic group in these trials over the proportion of the respective group among national cases. RQ=1 demonstrated appropriate representation, RQ < 1 demonstrated underrepresentation, and RQ>1 demonstrated overrepresentation. Comparison was made using Welch’s t-test with the male, non-Hispanic, and white populations used as comparator groups respectively. Significance was defined as p < 0.05. Data are presented as (Median [95% CI]).Results/Outcomes: Twenty-four clinical trials met inclusion criteria, representing a population of 3924 patients. Regarding sex, females were underrepresented (RQ=0.82 [0.59-0.99]), while males were appropriately represented (RQ=1.10 [0.99-1.42]). Representation of females was reduced compared to their male counterparts (p < 0.005). Regarding ethnicity, Hispanic/Latino patients were underrepresented (RQ=0.17 [0.00-0.89]); this was reduced compared to non-Hispanic/Latino patients (RQ=1.00 [0.86-1.11]) (p < 0.05). Regarding race, Asian/Pacific Islander and Native patients were underrepresented (RQ=0.20 [0.00-0.32]). White (RQ=1.027 [0.97-1.13]) and Black (RQ=0.60 [0.00-1.35]) patients were appropriately represented. Representation of Asian/Pacific Islander and Native patients was reduced compared to their white counterparts (p < 0.05). Representation of White and Black patients did not differ (p=0.097).Conclusion/

Discussion: Our findings demonstrate that female, Hispanic/Latino, and Asian/Pacific Islander and Native patients are underrepresented in clinical trials for Crohn’s disease and ulcerative colitis. Efforts should be made to recruit diverse populations to clinical trials and reduce systemic underrepresentation.Sex, Ethnic, and Racial Representation in Clinical Trials for Inflammatory Bowel DiseaseFemale, Hispanic/Latino, and Asian/Pacific Islander and Native patients are underrepresented in clinical trials for Crohn’s disease and ulcerative colitis. Representation of these groups was significantly reduced compared to their male, non Hispanic/Latino, and white counterparts respectively.