P4062 - Demographic Disparities of Clinical Trials Focused on Functional Gastrointestinal Disorders

Khushboo Gala, MBBS¹, Hector F.. Reyes Santiago, ², Wissam Ghusn, MD³, Raseen Tariq, MBBS⁴, Jean Fox, MD⁴, Victor Chedid, MD, MS^4
1Mayo Clinic School of Graduate Medical Education, Rochester, MN; ²University of Puerto Rico School of Medicine, Guaynabo, Puerto Rico; ³Boston Medical Center, Boston, MA; ⁴Mayo Clinic, Rochester, MN

Introduction: Functional gastrointestinal disorders (FGIDs) affect about 40% of the United States and global population, affecting patients of every age, sex, and racial and ethnic background. There is a paucity of data examining the populations recruited in clinical trials focused on FGID. Disparities in recruitment for clinical trials across medical specialties have been noted, which makes it challenging to translate their findings to the real world. We performed a systematic review of trials focused on FGIDs and examined the sex, racial and ethnic background, and age of participants.

Methods: We performed a systematic search of trials focused on FGIDs on ClinicalTrials.Gov, from inception to June 1, 2023. Specifically, we included trials focused on constipation, diarrhea, abdominal pain, irritable bowel syndrome, and esophageal dysmotility. Incomplete trials, trials conducted outside the United States and in languages other than English were excluded. Demographic details from all trials were abstracted and recorded. Descriptive analysis was performed with continuous data summarized as the mean and standard deviation (SD) and categorical data as percentages and values.

Results: We included a total of 371 trials, with a total of 105999 participants, with the maximum number of participants in trials related to irritable bowel syndrome and constipation (Table 1). The mean age of participants in all trials ranged between the ages of 28 and 48 (the mean age of all trials was 40.66 ± 11.28). All studies reported sex, with a mean of 62% female participants across all trials. Race and ethnicity were inconsistently reported across studies, however, a mean of 80% of participants were white.

Discussion: We found a preponderance of middle-aged white female adult participants in trials focused on FGIDs. Although it is difficult to draw exact comparisons of this against the prevalence of FGIDs in the community given the lack of high-quality data regarding the same, our data noted multiple disparities in these participants. Specifically, older adults and non-white races are not equitably reflected in clinical trials. Lack of adequate representation may affect recommended treatments and health outcomes in underrepresented populations; our data may represent changes needed in recruitment strategies for trials focused on FGIDs.


Disclosures:


Khushboo Gala, MBBS¹, Hector F.. Reyes Santiago, ², Wissam Ghusn, MD³, Raseen Tariq, MBBS⁴, Jean Fox, MD⁴, Victor Chedid, MD, MS⁴. P4062 - Demographic Disparities of Clinical Trials Focused on Functional Gastrointestinal Disorders, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.