New year, old problem: are researchers doing enough to recruit patients from racial and ethnic minority groups into rheumatology clinical trials?
Two poster presentations at #ACR24 looked at racial diversity in clinical trials in myositis and axial spondyloarthritis, finding that historically-poor representation persists to this day. For axial spondyloarthritis, the reporting of race in trials has improved over time: from 9.1% in 2000–2010 up to 100% in 2016–2020.1 However, representation of Black people has decreased between these time periods: from 4.1% to 0.8%, although representation of Asians and Native Americans has increased in recent years. Among myositis studies, 42% did not report race in publications, and of those that did, 3.7% patients involved in the studies were Black.2
Studies focussing on minority populations are rare. For rheumatology therapies, example studies include EMBRACE (Efficacy and Safety of [Benlysta] Belimumab in Black Race Patients with SLE) and EMPACTA (Evaluating Minority Patients with Actemra [tocilizumab]), although EMPACTA was not in one of tocilizumab’s many rheumatology indications, but for COVID-19-associated pneumonia.3,4
The belimumab story should be a warning to the rheumatology community of what happens without sufficient racial group representation in a Phase 3 study. The FDA requested a “Use with caution in Black/African-American patients” statement in the label and a post-marketing commitment to perform the EMBRACE study. Hindered by the usual barriers to enrol into post-marketing trials in addition to the existing challenges of enrolling minority patients, EMBRACE recruitment was slow and resulted in an underpowered study. The caution language persisted in the belimumab label for 8 years until 2019, and likely caused delays and confusion in prescribing and authorising/reimbursing prescription.5
Some lessons from the belimumab experience were learned, and new programs were launched, such as ‘Improving Minority Participation and Awareness in Clinical Trials (IMPACT+)’ which provides resources to increase awareness of the clinical trial process in the African American community by working with churches across America.6
Much could be applied in other disease areas, but have other researchers learned the value of pushing for study diversity and transparent reporting of race? Review of a handful of recent myositis trials shows that a 2024 belimumab study reports race, whereas a 2022 tocilizumab publication includes only ‘Caucasian: yes/no’.7,8 Without transparency in reporting diversity, and a commitment to change, the problem will likely remain unaddressed.
So what more can be done? Some of the key learnings from EMBRACE were the importance of encouraging local collaboration between healthcare professionals and advocacy groups, engaging in community outreach, and raising the visibility of study sites for surrounding communities.5 When designing a study, consider the accessibility of study sites and the provisions that can be made to engage and assist patients. Disease associations may already have materials available for advocacy and outreach to people of colour, but further work can be funded through grants and collaboration. For example, the Myositis Association have a women of colour committee providing resources to healthcare professionals and patients – such as illustrations of ‘Dermatomyositis Rashes in Patients of Color’.9 The MIHRA group (author of the ACR myositis poster) have clinical trial listings for patients, and have a Clinical Trial Sites Network to act as a community-based platform for new local trial sites to learn from others.10
What does this mean for us? As medical communications specialists, we at TVF can do our part in helping pharmaceutical companies reach out to minority communities and, at minimum, ensuring that race gets reported as part of high-quality publication support.11
By Dr Hannah Jedrey
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