Evaluating Diversity in Thyroid Cancer Clinical Trials: Application of the Clinical Diversity Rating Framework.

Background: Despite progress in recruiting representative patient samples for clinical trials, disparities persist. This study quantifies the representation of historically marginalized groups-female patients, members of racial/ethnic minority groups, and older patients-in thyroid cancer clinical trials and proposes strategies for improving their participation.

Methods: We performed a systematic review and meta-analysis of thyroid cancer treatment studies conducted in the United States and published between January 2018 and December 2023, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes (PRISMA) guidelines. Studies were sourced from EMBASE and PubMed. Independent and duplicate screening and data extraction were conducted to ensure accuracy. Extracted data included trial interventions, clinical phases, sample sizes, demographic characteristics of participants, and funding sources. Studies were evaluated using the Clinical Trial Diversity Rating framework to assess the inclusion rates of diverse participant groups compared to their prevalence rates for thyroid cancer.

Results: We found that US-based clinical trials for thyroid cancer frequently underrepresented female and non-white individuals. In over half of studies, male participants outnumbered female participants. Reporting of race and ethnicity information was inadequate, with 9/13 studies failing to provide any demographic breakdown. Among the four studies that did report race and ethnicity data, none achieved adequate representation of minority patients. Additionally, there was a notable lack of reporting on participant age bands, despite the relatively high incidence of thyroid cancer in adults aged 60 and above.

Conclusions: Our findings highlight the persistent underrepresentation of women, non-white racial/ethnic groups, and older adults in thyroid cancer trials. Urgent efforts are needed to address these disparities, particularly given the increasing rates of thyroid cancer among women and the healthcare access disparities in marginalized communities.