TY - JOUR
T1 - Tackling diversity in prostate cancer clinical trials
T2 - A report from the diversity working group of the IRONMAN registry
AU - McKay, Rana R.
AU - Gold, Theresa
AU - Zarif, Jelani C.
AU - Chowdhury-Paulino, Ilkania M.
AU - Friedant, Adam
AU - Gerke, Travis
AU - Grant, Marie
AU - Hawthorne, Kelly
AU - Heath, Elisabeth
AU - Huang, Franklin W.
AU - Jackson, Maria D.
AU - Mahal, Brandon
AU - Ogbeide, Osarenren
AU - Paich, Kellie
AU - Ragin, Camille
AU - Rencsok, Emily M.
AU - Simmons, Stacey
AU - Yates, Clayton
AU - Vinson, Jake
AU - Kantoff, Philip W.
AU - George, Daniel J.
AU - Mucci, Lorelei A.
N1 - Funding Information:
The authors acknowledge support from the Movember Foundation, Bayer HealthCare Pharmaceuticals Inc, Astellas Pharma Global Development Inc, Sanofi-Genzyme, AstraZeneca Pharmaceuticals LP, Amgen Inc, and Janssen Scientific Affairs, LLC. R.R.M., J.C.Z., F.W.H., B.M., and L.A.M. were Prostate Cancer Foundation Young Investigators. They would like to thank the patients and their caregivers and family for participating in the IRONMAN study. They thank the Prostate Cancer Clinical Trials Consortium for coordinating national and international efforts for this study.
Funding Information:
J.C.Z. is supported by NCI K22CA237623. This project is a cross-cancer center collaboration (P30 006516, P30 CA023100, P30 022453, P30 CA008748, P30 014236, and P30 006973). The PCCTC is supported in part by the US Army Prostate Cancer Program.
Publisher Copyright:
© 2021 by American Society of Clinical Oncology
PY - 2021/4
Y1 - 2021/4
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85104212464&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85104212464&partnerID=8YFLogxK
U2 - 10.1200/GO.20.00571
DO - 10.1200/GO.20.00571
M3 - Article
C2 - 33835826
AN - SCOPUS:85104212464
SN - 2378-9506
SP - 495
EP - 505
JO - JCO Global Oncology
JF - JCO Global Oncology
IS - 7
ER -