Race Reporting and Diversity in US Food and Drug Administration (FDA) Registration Trials for Prostate Cancer; 2006-2020

Racial diversity in clinical trials serves as a metric of equality and access to healthcare. However, unfortunately, trial populations frequently do not represent populations they intend to emulate. Current International Committee of Medical Editors (ICJME) guidelines recommend as a minimum, descriptive data on race and ethnicity. Furthermore, US Food and Drug Administration (FDA) guidelines introduced in 2016 also recommend race should be reporting universally, as a minimum of 5 categories.

Prostate Cancer shows significant disproportionality in racial prevalence. We, therefore, wanted to investigate how frequently race was reported in pivotal FDA prostate cancer drug registration trials, analysing both the licensing publication and clinical trial study reports.¹ Furthermore, we wanted to look at the overall racial diversity in registration trials and the impact of new FDA race reporting guidelines.

Over a 15-year period, 17 clinical trials using 10 unique drugs were identified. We found that overall race reporting compliance in licensing publication was 53%. However, for studies where race was unreported in the licensing publication, 88% included information within the FDA study report. Following the introduction of the new FDA guidelines, reporting rates in licensing publications remain relatively unchanged (53% vs 55%).

Looking at the 18,455 participants included in prostate cancer registration (pivotal) trials, 76% were White/Caucasian, 8% Asian, 3% Black or African American, 2% Other, and 10.5% Unknown. This study concurs with others showing significant under enrolment of non-white participants. Only one licensing publication acknowledged this underrepresentation as a significant limitation.

We have expanded this study to include all GU cancers, which we reported at GU ASCO 2021.² This reported a similar picture in renal and bladder cancer with poor reporting and underrepresentation of non-white participants. In contrast, we have also investigated breast cancer (reporting at ESMO breast), which shows an underrepresentation of non-white participants, however since the introduction of the new FDA guidelines we noted a significant improvement in reporting (50% vs 85%).

Given the importance of racial diversity and reporting in ensuring the equality, validity, and scientific rigor of research, reporting should be universal following both FDA and ICJME guidelines. The recruitment of Black or African Americans and other minority participants to prostate cancer trials should be a research priority.

Written by: Mark P. Lythgoe, Department of Surgery & Cancer, Imperial College London, Hammersmith Hospital, London, UK

References:

Lythgoe MP, Krell J, Savage P, et al. Race reporting and diversity in US food and drug administration (FDA) registration trials for prostate cancer; 2006–2020. Prostate Cancer and Prostatic Diseases 2021; 1–4. doi:10.1038/s41391-021-00361-0
Lythgoe M, Julve M, Krell J, et al. Racial diversity and reporting in FDA registration trials for genitourinary (GU) cancers from 2006-20. Journal of Clinical Oncology 2021;39:22–22. doi:10.1200/jco.2021.39.6_suppl.22

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