2025 Poster Presentations
P208: GENDER DISPARITY IN PITUITARY ADENOMA CLINICAL TRIALS MAY UNINTENTIONALLY BIAS RESULTS AND APPLICATION TO CLINICAL SCENARIOS
Alexa R Lauinger1; Suguna Pappu, MD2; Ann Stroink3; 1Carle Illinois College of Medicine; 2Department of Neurosurgery, Carle Foundation Hospital; 3Illinois State University
Background: Demographic disparities in clinical trials can unintentionally bias results and limit the applicability of outcomes to the general population. This challenge spans across various medical specialties and disease types but is particularly impactful in diseases with known variations in outcomes or prognosis based on gender or race. One example is pituitary adenomas, which exhibit differences in females, such as smaller size, distinct gene expression, and higher recurrence risk. Additionally, females may face different risks for post-operative conditions like diabetes insipidus and hyponatremia. Therefore, it is crucial to ensure similar representation in study cohorts for such diseases. Moreover, the higher prevalence of prolactinomas and corticotropic adenomas in females underscores the need for accurate representation in clinical trial cohorts.
Methods: Using ClinicalTrials.gov, we queried studies related to pituitary adenomas, including functional and nonfunctional subtypes. Demographics and study characteristics were collected. The racial disparity index (RDI) was calculated using United States census data in the formula RDI = ((Blackstudy/Blackpop) + (Otherstudy/Otherpop))/(Whitestudy/Whitepop), where pop refers to the expected number of participants based on the population. Gender disparity was defined as having the percent of female study participants in the cohort less than 50%; while in the case of prolactinomas and corticotropic adenomas, that have a strong female predominance, gender disparity was defined as less than 80%.
Results: 178 trials were originally queried; however, 8 were removed for including other pathologies, 74 had not completed recruiting, and 49 did not report gender or racial demographics. After screening, 47 trials were included to look at gender disparity and 18 were included to look at racial disparity.
25 of 47 trials (53.2%) demonstrated gender disparity, which was more common in studies exploring a drug type intervention (p-value = 0.03). However, adenoma subtype, funding source, and country were not significantly associated with gender disparity. 4 of 18 US-based trials (22.2%) showed racial disparity. Study funding, adenoma subtype, and intervention type did not demonstrate any significant association with racial disparity.
Discussion: Our findings indicate that a significant percentage of clinical trials on pituitary adenomas exhibit gender or racial disparities in their study populations compared to the general population. The observed gender disparity appears linked to the type of intervention, possibly due to the higher prevalence of functional adenomas requiring surgical removal among females. Despite this, such imbalances in study cohorts could influence patient and physician decision-making in clinical settings. The results of this study may be limited by the small sample size, particularly in trials reporting racial demographics.
Conclusions: This study demonstrates a need for increased awareness of study cohorts in clinical trials, especially for diseases that have a strong predominance for gender or race. These studies should appropriately represent the population or limit the study results to apply to a narrower demographic to ensure accurate application to clinic scenarios. Further research is needed to explore how the outcomes of these studies may be associated with disparities in their study cohorts.