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McKay RR , Gold T , Zarif JC , Chowdhury-Paulino IM , Friedant A , Gerke T , Grant M , Hawthorne K , Heath E , Huang FW , Jackson MD , Mahal B , Ogbeide O , Paich K , Ragin C , Rencsok EM , Simmons S , Yates C , Vinson J , Kantoff PW , George DJ , Mucci LA
Tackling Diversity in Prostate Cancer Clinical Trials: A Report From the Diversity Working Group of the IRONMAN Registry
JCO Glob Oncol. 2021 Apr;7 :495-505
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Prostate cancer disproportionately affects racial and ethnic minority populations. Reasons for disparate outcomes among minority patients are multifaceted and complex, involving factors at the patient, provider, and system levels. Although advancements in our understanding of disease biology have led to novel therapeutics for men with advanced prostate cancer, including the introduction of biomarker-driven therapeutics, pivotal translational studies and clinical trials are underrepresented by minority populations. Despite attempts to bridge the disparities gap, there remains an unmet need to expand minority engagement and participation in clinical trials to better define the impact of therapy on efficacy outcomes, quality of life, and role of biomarkers in diverse patient populations. The IRONMAN registry (ClinicalTrials.gov identifier: NCT03151629), a global, prospective, population-based study, was borne from this unmet medical need to address persistent gaps in our knowledge of advanced prostate cancer. Through integrated collection of clinical outcomes, patient-reported outcomes, epidemiologic data, and biospecimens, IRONMAN has the goal of expanding our understanding of how and why prostate cancer outcomes differ by race and ethnicity. To this end, the Diversity Working Group of the IRONMAN registry has developed informed strategies for site selection, recruitment, engagement and retention, and trial design and eligibility criteria to ensure broad inclusion and needs awareness of minority participants. In concert with systematic strategies to tackle the complex levels of disparate care, our ultimate goal is to expand minority engagement in clinical research and bridge the disparities gap in prostate cancer care.
2687-8941 McKay, Rana R Orcid: 0000-0002-0581-7963 Gold, Theresa Zarif, Jelani C Orcid: 0000-0003-3880-2124 Chowdhury-Paulino, Ilkania M Orcid: 0000-0001-7331-7576 Friedant, Adam Orcid: 0000-0001-5756-2774 Gerke, Travis Orcid: 0000-0002-9500-8907 Grant, Marie Hawthorne, Kelly Heath, Elisabeth Orcid: 0000-0003-1381-2713 Huang, Franklin W Jackson, Maria D Mahal, Brandon Ogbeide, Osarenren Paich, Kellie Ragin, Camille Orcid: 0000-0003-0816-4942 Rencsok, Emily M Orcid: 0000-0002-6935-1410 Simmons, Stacey Yates, Clayton Orcid: 0000-0001-5420-9852 Vinson, Jake Kantoff, Philip W George, Daniel J Orcid: 0000-0002-0836-8542 Mucci, Lorelei A Journal Article United States JCO Glob Oncol. 2021 Apr;7:495-505. doi: 10.1200/GO.20.00571.