Elliott Freudenburg1, Iyla Bagheri1, Sunay Srinivas1, Ariza Martinez1, Nagireddy Putluri2, Zachary Klaassen3, Ashish M Kamat4, Badrinath R Konety5, William Y Kim6,7, Lars Dyrskjøt8, David J McConkey9, Stephen J Freedland10, Peter C Black11, Siamak Daneshmand12, James W F Catto13, Stephen B Williams14. 1. Department of Surgery, Division of Urology, The University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555, USA. 2. Department of Molecular and Cellular Biology, Dan L. Duncan Cancer Center, Advanced Technology Core, Alkek Center for Molecular Discovery, Baylor College of Medicine, Houston, TX, USA. 3. Department of Surgery, Section of Urology, Medical College of Georgia, Augusta University, Augusta, GA, USA. 4. Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. 5. Virginia Piper Cancer Center and Piper Breast Centers, Allina Health Cancer Institute, Minneapolis, MN, USA. 6. Division of Hematology/Oncology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA. 7. Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA. 8. Department of Molecular Medicine, Aarhus University Hospital, Aarhus, Denmark. 9. Johns Hopkins Greenberg Bladder Cancer Institute, Brady Urological Institute, Johns Hopkins University, Baltimore, MD, USA. 10. Department of Urology, Cedars Sinai Medical Center, Los Angeles, CA, USA. 11. Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada. 12. Department of Urology, USC/Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA. 13. Academic Urology Unit, University of Sheffield, Sheffield, UK. 14. Department of Surgery, Division of Urology, The University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555, USA. stbwilli@utmb.edu.
Abstract
PURPOSE: To systematically review the literature to investigate racial disparities among bladder cancer clinical trial enrollees. METHODS: A systematic review was conducted using Ovid, MEDLINE® to identify clinical trials between 1970 and 2020. Articles were reviewed and were included if they assessed race in their outcomes reporting among bladder cancer patients enrolled in clinical trials. The review was conducted in accordance with the PRISMA statement. RESULTS: We identified 544 clinical trials meeting our initial search criteria, with only 24 (4.4%) studies reporting racial demographic data. Enrollees were largely Caucasian (81-98%), with a strikingly small proportion of enrolled patients consisting of African-Americans (2-8%) and Hispanics (2-5%). Only one of the studies reported results on the efficacy and safety/tolerability of the tested treatment separately for racial groups and performed analyses stratified by race. CONCLUSION: Race is poorly studied in bladder cancer clinical trials. Trial cohorts may not reflect multicultural populations. The potential association between race and efficacy, safety or tolerability of the tested interventions is unknown. Given the up to twofold increase in bladder cancer-specific death among African-Americans, further research is needed to address the impact of race in clinical trials, while encompassing socioeconomic factors and disease risk factor exposures.
PURPOSE: To systematically review the literature to investigate racial disparities among bladder cancer clinical trial enrollees. METHODS: A systematic review was conducted using Ovid, MEDLINE® to identify clinical trials between 1970 and 2020. Articles were reviewed and were included if they assessed race in their outcomes reporting among bladder cancer patients enrolled in clinical trials. The review was conducted in accordance with the PRISMA statement. RESULTS: We identified 544 clinical trials meeting our initial search criteria, with only 24 (4.4%) studies reporting racial demographic data. Enrollees were largely Caucasian (81-98%), with a strikingly small proportion of enrolled patients consisting of African-Americans (2-8%) and Hispanics (2-5%). Only one of the studies reported results on the efficacy and safety/tolerability of the tested treatment separately for racial groups and performed analyses stratified by race. CONCLUSION: Race is poorly studied in bladder cancer clinical trials. Trial cohorts may not reflect multicultural populations. The potential association between race and efficacy, safety or tolerability of the tested interventions is unknown. Given the up to twofold increase in bladder cancer-specific death among African-Americans, further research is needed to address the impact of race in clinical trials, while encompassing socioeconomic factors and disease risk factor exposures.
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