Minority Enrollment in Phase II and III Clinical Trials in Urologic Oncology

Abstract

PURPOSE Proportionate minority representation in clinical trials is an important step toward addressing health care inequities. Given the paucity of data on this topic in urologic oncology, we sought to quantify the enrollment of minority patients in clinical trials studying prostate, kidney, and bladder/urothelial cancers. METHODS The ClincialTrials.gov database was queried for completed phase II and III interventional trials in prostate, kidney, and bladder cancers. The SEER database was used to calculate the US prevalence of these genitourinary cancers. Representation quotients (RQ) were calculated to describe the relative proportion of each racial/ethnic group enrolled in clinical trials over the proportion of persons from each group among national cancer cases by cancer type. RESULTS Of 341 trials that met initial eligibility criteria, only 169 (49.7%) reported data on race or ethnicity. Aggregate RQs from 2000 to 2017 showed that White patients were continually over-represented in trials for all cancer types. Black and Asian patients were poorly represented across all cancer types. When stratified by 3-year increments, the RQs remained stable for all races, from 2000 to 2017. When stratified by ethnicity, Hispanic patients were under-represented across all cancer types in the study period. When examining representation by funding source, we found that US government–funded clinical trials proportionally enroll the most diverse patient populations over those funded by academic institutions and industry. Interestingly, more than 50% of the trials examined did not report race nor ethnicity, highlighting a crucial flaw in investigator compliance with federal clinical trial mandates. CONCLUSION Clinical trials targeting prostate, kidney, and bladder cancers continue to under-represent racial/ethnic minority patients. On the basis of the incidence of these cancers within minority populations, efforts should focus on creating racially and ethnically inclusive cancer research.

Participation of Patients From Racial and Ethnic Minority Groups in Phase 1 Early Cancer Drug Development Trials in the US, 2000-2018

“…Inclusion of patients from racial and ethnic minority groups in phase 1 cancer trials was worse than observed in phase 3 trials, especially among Black participants (−6.9% difference in Black participants in phase 1 trials in 2012-2018 compared with −2.6% difference in phase 3 trials since year 2011). 4,9 Similar disparities in phase 1 cancer clinical trial enrollment have been noted in studies conducted at single institutions. 10 When examining racial and ethnic disparities in clinical research, it is essential to acknowledge the harms that individuals of racial and ethnic minority groups have experienced at the hands of the US health care system, especially in the research setting.…”

Prostate cancer screening in Black men in Canada: a case for risk-stratified care

“…However, this study reported that only 4% of participants were non-Hispanic Black men, which limits the external validity of the findings. 40 This is in the context of other studies that have shown that, when compared with white patients, Black patients in the US are more likely to have a larger tumour volume, 41 elevated in itial PSA levels, 42 longer time intervals between screenings 43 and earlier transformation to clinically important disease. 18,19 If Black people have been shown to present with more aggressive and advanced disease in PSA-eligible populations, applying averagerisk guidelines to this population ignores their lived reality.…”

“…Clinical trials of prostate cancer screening and treatment have not adequately included Black participants. 39,40 Both the CUA and USPSTF guidelines on prostate cancer refer to data from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. However, this study reported that only 4% of participants were non-Hispanic Black men, which limits the external validity of the findings.…”

Dépistage du cancer de la prostate chez les hommes noirs au Canada : Argument en faveur des soins stratifiés en fonction du risque

“…Les essais cliniques sur le dépistage et le traitement du cancer de la prostate n'ont pas inclus suffisamment de participants noirs 39,40 . Les lignes directrices de l'AUC et du USPSTF sur le cancer de la prostate font référence à des données tirées de l'étude Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.…”

“…Les lignes directrices de l'AUC et du USPSTF sur le cancer de la prostate font référence à des données tirées de l'étude Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Or, cette étude a révélé que seulement 4 % des participants étaient des hommes noirs non hispaniques, ce qui limite la validité externe de ses conclusions 40 . Et elle se situe dans un contexte où d'autres études ont montré que, comparativement aux patients blancs, les patients noirs aux États-Unis sont plus susceptibles de présenter une tumeur plus volumineuse 41 , des taux initiaux d'APS élevés 42 , des contrôles plus espacés 43 et une évolution plus précoce en maladie cliniquement importante 18,19 .…”