Top Research in Gout from ACR Convergence 2024 at a Glance

‘My picks for the top research in gout presented at ACR Convergence 2024’

ACR CONVERGENCE 2024—Approximately 70 abstracts about gout from around the globe were accepted for presentation at ACR Convergence 2024. My picks reflect my passion and interests in improving gout management.

1. Abstract 0178

Are Participants in Gout Clinical Trials Representative of People with Gout in the General Population? Liu et al.¹

Industry-led clinical trials play an important role in drug development and regulatory approvals. As clinicians, we rely on clinical trial data to guide our treatment decisions and to develop treatment recommendations and consensus guidelines. However, clinical trial inclusion and exclusion criteria, which determine the trial population, may not reflect the real-world disease population. This may be especially true in gout clinical trials because people with gout have many co-morbidities, including chronic kidney disease, which is frequently an exclusion criterion for clinical trials.

In the study presented by Liu et al., demographics and comorbidity data from 12 phase 3 clinical trials of gout medications approved by the FDA from 2009 to 2023 were compared with published data from participants with gout in the 2007–08 and 2015–16 U.S. National Health and Nutrition Examination Survey (NHANES). Not surprisingly, there was under-representation of women, older individuals, non-white ethnicities and those with comorbid health conditions commonly experienced by people with gout including hypertension, prior myocardial infarction, nephrolithiasis and diabetes.

The under-representation of non-white ethnicities is troubling. Efforts have been made by funders such as the National Institutes of Health (NIH) to address this under-representation. The Revitalisation Act of 1993 requires the Director of the NIH to ensure that members of “minority” groups are included in clinical trials and that the trial is designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect members of minority groups differently than other trial participants.

Bias, conscious or unconscious, among healthcare professionals, researchers and the healthcare system likely also has an impact on recruitment of non-white ethnic groups into clinical trials.

The challenge for us as a community is to work in partnership with non-white populations to develop culturally appropriate, acceptable and effective systems to overcome disparities and enable a pathway to be involved in clinical trials and help achieve health equity.

In this regard, it was also pleasing to see a Meet the Panel session at ACR Convergence 2024 discuss this topic.