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      Comparative Survival of Asian and White Metastatic Castration-Resistant Prostate Cancer Men Treated With Docetaxel

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          Abstract

          There are few data regarding disparities in overall survival (OS) between Asian and white men with metastatic castration-resistant prostate cancer (mCRPC). We compared OS of Asian and white mCRPC men treated in phase III clinical trials with docetaxel and prednisone (DP) or a DP-containing regimen. Individual participant data from 8820 men with mCRPC randomly assigned on nine phase III trials to receive DP or a DP-containing regimen were combined. Men enrolled in these trials had a diagnosis of prostate adenocarcinoma. The median overall survival was 18.8 months (95% confidence interval [CI] = 17.4 to 22.1 months) and 21.2 months (95% CI = 20.8 to 21.7 months) for Asian and white men, respectively. The pooled hazard ratio for death for Asian men compared with white men, adjusted for baseline prognostic factors, was 0.95 (95% CI = 0.84 to 1.09), indicating that Asian men were not at increased risk of death. This large analysis showed that Asian men did not have shorter OS duration than white men treated with docetaxel.

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          Systematic Review and Meta-Analysis of the Magnitude of Structural, Clinical, and Physician and Patient Barriers to Cancer Clinical Trial Participation

          Abstract Background Barriers to cancer clinical trial participation have been the subject of frequent study, but the rate of trial participation has not changed substantially over time. Studies often emphasize patient-related barriers, but other types of barriers may have greater impact on trial participation. Our goal was to examine the magnitude of different domains of trial barriers by synthesizing prior research. Methods We conducted a systematic review and meta-analysis of studies that examined the trial decision-making pathway using a uniform framework to characterize and quantify structural (trial availability), clinical (eligibility), and patient/physician barrier domains. The systematic review utilized the PubMed, Google Scholar, Web of Science, and Ovid Medline search engines. We used random effects to estimate rates of different domains across studies, adjusting for academic vs community care settings. Results We identified 13 studies (nine in academic and four in community settings) with 8883 patients. A trial was unavailable for patients at their institution 55.6% of the time (95% confidence interval [CI] = 43.7% to 67.3%). Further, 21.5% (95% CI = 10.9% to 34.6%) of patients were ineligible for an available trial, 14.8% (95% CI = 9.0% to 21.7%) did not enroll, and 8.1% (95% CI = 6.3% to 10.0%) enrolled. Rates of trial enrollment in academic (15.9% [95% CI = 13.8% to 18.2%]) vs community (7.0% [95% CI = 5.1% to 9.1%]) settings differed, but not rates of trial unavailability, ineligibility, or non-enrollment. Conclusions These findings emphasize the enormous need to address structural and clinical barriers to trial participation, which combined make trial participation unachievable for more than three of four cancer patients.
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            Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials.

            The National Institutes of Health (NIH) Revitalization Act of 1993 mandated the appropriate inclusion of minorities in all NIH-funded research. Twenty years after this act, the proportion of minority patients enrolled in cancer clinical trials remains persistently low. Clinical trials are vehicles for the development and evaluation of therapeutic and preventive agents under scientifically rigorous conditions. Without representation in trials, it is projected that disparities in the cancer burden for minorities will increase. For this review article, the authors counted the frequency with which minorities were the primary focus of National Cancer Institute-sponsored clinical trials, examined citations from the PubMed database focusing on the search terms "NIH Revitalization Act of 1993" and "enhancing minority accrual to cancer clinical trials," and supplemented the review with their expertise in NIH-funded research related to minority accrual in cancer clinical trials. The reporting and analyses of data based on minorities in clinical trials remain inadequate. Less than 2% of the National Cancer Institute's clinical trials focus on any racial/minority population as their primary emphasis. The current review of the literature indicated that the percentage of authors who reported their study sample by race/ethnicity ranged from 1.5% to 58%, and only 20% of the randomized controlled studies published in a high-impact oncology journal reported analyzing results by race/ethnicity. Proportionately greater population increases in minorities, accompanied by their persistent and disproportionate cancer burden, reinforce the need for their greater representation in clinical trials. Renewing the emphasis for minority participation in clinical trials is warranted. Policy changes are recommended. © 2014 American Cancer Society.
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              The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

              Fewer than one in 20 adult patients with cancer enroll in cancer clinical trials. Although barriers to trial participation have been the subject of frequent study, the rate of trial participation has not changed substantially over time. Barriers to trial participation are structural, clinical, and attitudinal, and they differ according to demographic and socioeconomic factors. In this article, we characterize the nature of cancer clinical trial barriers, and we consider global and local strategies for reducing barriers. We also consider the specific case of adolescents with cancer and show that the low rate of trial enrollment in this age group strongly correlates with limited improvements in cancer population outcomes compared with other age groups. Our analysis suggests that a clinical trial system that enrolls patients at a higher rate produces treatment advances at a faster rate and corresponding improvements in cancer population outcomes. Viewed in this light, the issue of clinical trial enrollment is foundational, lying at the heart of the cancer clinical trial endeavor. Fewer barriers to trial participation would enable trials to be completed more quickly and would improve the generalizability of trial results. Moreover, increased accrual to trials is important for patients, because trials provide patients the opportunity to receive the newest treatments. In an era of increasing emphasis on a treatment decision-making process that incorporates the patient perspective, the opportunity for patients to choose trial participation for their care is vital.
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                Author and article information

                Journal
                JNCI Cancer Spectr
                JNCI Cancer Spectr
                jncics
                JNCI Cancer Spectrum
                Oxford University Press
                2515-5091
                April 2020
                29 January 2020
                29 January 2020
                : 4
                : 2
                : pkaa003
                Affiliations
                [p1 ] Department of Biostatistics and Bioinformatics, School of Medicine , Duke University, Durham, NC, USA
                [p2 ] Department of Mathematics and Statistics, Old Dominion University , Norfolk, VA, USA
                [p3 ] Public Health Sciences Division, Fred Hutchinson Cancer Research Center , Seattle, WA, USA
                [p4 ] Department of Medical Oncology, Peter MacCallum Cancer Centre , Parkville, Australia
                [p5 ] Medical Oncology, Yale School of Medicine , New Haven, CT, USA
                [p6 ] President, Christus San Rosa Hospital Medical Center , San Antonio, TX, USA
                [p7 ] Medical Oncology, British Columbia Cancer Agency - Vancouver Centre , Vancouver, BC, USA
                [p8 ] Division of Clinical Studies, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust , Sutton, UK
                [p9 ] Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX, USA
                [p10 ] Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University , Baltimore, MD, USA
                [p11 ] Genitourinary Oncology, Department of Medicine University of Southern California Norris Comprehensive Cancer Center , Los Angeles, CA, USA
                [p12 ] Medical Oncology, Gustave Roussy , Villejuif, France
                [p13 ] Genitourinary Oncology Service, Department of Medicine. Memorial Sloan Kettering Cancer Center , New York, NY, USA
                [p14 ] Department of Medicine, University of Washington School of Medicine and Fred Hutchinson Cancer Research Center , Seattle, WA, USA
                [p15 ] Department of Medical Oncology, Princess Margaret Cancer Centre, University of Toronto , Toronto, ON, Canada
                [p16 ] Department of Medicine, and University of California San Francisco Helen Diller Family Comprehensive Cancer Center, University of California San Francisco , San Francisco, CA, USA
                [p17 ] Medical Oncology and Urology, Sidney Kimmel Cancer Center at Thomas Jefferson University , Philadelphia, PA, USA
                Author notes
                Correspondence to: Susan Halabi, PhD, Department of Biostatistics and Bioinformatics, School of Medicine, Duke University, 2424 Erwin Road, Suite 11088, Durham, NC 27710, USA (e-mail: susan.halabi@ 123456duke.edu ).
                Author information
                http://orcid.org/0000-0003-4135-2777
                Article
                pkaa003
                10.1093/jncics/pkaa003
                7190204
                60da8746-f1cc-40b6-8de3-2c363e3f788f
                © The Author(s) 2020. Published by Oxford University Press.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contactjournals.permissions@oup.com

                History
                : 21 August 2019
                : 16 December 2019
                : 21 January 2020
                Page count
                Pages: 5
                Funding
                Funded by: US Army Medical Research;
                Funded by: National Institutes of Health/National Cancer Institute;
                Award ID: U10CA180888
                Award ID: U10CA180819
                Categories
                Brief Communication

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