Landmark Cancer Clinical Trials and Real-World Patient Populations: Examining Race and Age Reporting

Background: Concern exists that the clinical trial populations differ from respective cancer populations in terms of their age distribution affecting the generalizability of the results, especially in underrepresented minorities. We hypothesized that the clinical trials that do not report race are l...

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Autores principales:	Thejus Jayakrishnan, Sonikpreet Aulakh, Mizba Baksh, Kianna Nguyen, Meghna Ailawadhi, Ayesha Samreen, Ricardo Parrondo, Taimur Sher, Vivek Roy, Rami Manochakian, Aneel Paulus, Asher Chanan-Khan, Sikander Ailawadhi
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	clinical trials cancer disparity age race Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/4902baa6ea224b818c6a583586ed5b2c
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spelling	oai:doaj.org-article:4902baa6ea224b818c6a583586ed5b2c2021-11-25T17:03:48ZLandmark Cancer Clinical Trials and Real-World Patient Populations: Examining Race and Age Reporting10.3390/cancers132257702072-6694https://doaj.org/article/4902baa6ea224b818c6a583586ed5b2c2021-11-01T00:00:00Zhttps://www.mdpi.com/2072-6694/13/22/5770https://doaj.org/toc/2072-6694Background: Concern exists that the clinical trial populations differ from respective cancer populations in terms of their age distribution affecting the generalizability of the results, especially in underrepresented minorities. We hypothesized that the clinical trials that do not report race are likely to suffer from a higher degree of age disparity. Methods: Food and Drug Administration (FDA) drug approvals from July 2007 to June 2019 were reviewed to identify oncology approvals, and trials with age details were selected. The outcomes studied were the weighted mean difference in age between the clinical trial population and real-world population for various cancers, the prevalence of race reporting and association of age and race reporting with each other. Results: Of the 261 trials, race was reported in 223 (85.4%) of the trials, while 38 trials (14.6%) had no mention of race. Race reporting improved minimally over time: 29 (85.3%) in 2007–2010 vs. 49 (80.3%) in 2011–2014 vs. 145 (85.4%) during the period 2015–2019 (<i>p</i>-value = 0.41). Age discrepancy between the clinical trial population and the real-world population was higher for studies that did not report race (mean difference −8.8 years (95% CI −12.6 to −5.0 years)) vs. studies that did report it (mean difference −5.1 years, (95% CI −6.4 to −3.7 years), <i>p</i>-value = 0.04). Conclusion: The study demonstrates that a significant number of clinical trials leading to cancer drug approvals suffer from racial and age disparity when compared to real-world populations, and that the two factors may be interrelated. We recommend continued efforts to recruit diverse populations.Thejus JayakrishnanSonikpreet AulakhMizba BakshKianna NguyenMeghna AilawadhiAyesha SamreenRicardo ParrondoTaimur SherVivek RoyRami ManochakianAneel PaulusAsher Chanan-KhanSikander AilawadhiMDPI AGarticleclinical trialscancerdisparityageraceNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancers, Vol 13, Iss 5770, p 5770 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	clinical trials cancer disparity age race Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	clinical trials cancer disparity age race Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Thejus Jayakrishnan Sonikpreet Aulakh Mizba Baksh Kianna Nguyen Meghna Ailawadhi Ayesha Samreen Ricardo Parrondo Taimur Sher Vivek Roy Rami Manochakian Aneel Paulus Asher Chanan-Khan Sikander Ailawadhi Landmark Cancer Clinical Trials and Real-World Patient Populations: Examining Race and Age Reporting
description	Background: Concern exists that the clinical trial populations differ from respective cancer populations in terms of their age distribution affecting the generalizability of the results, especially in underrepresented minorities. We hypothesized that the clinical trials that do not report race are likely to suffer from a higher degree of age disparity. Methods: Food and Drug Administration (FDA) drug approvals from July 2007 to June 2019 were reviewed to identify oncology approvals, and trials with age details were selected. The outcomes studied were the weighted mean difference in age between the clinical trial population and real-world population for various cancers, the prevalence of race reporting and association of age and race reporting with each other. Results: Of the 261 trials, race was reported in 223 (85.4%) of the trials, while 38 trials (14.6%) had no mention of race. Race reporting improved minimally over time: 29 (85.3%) in 2007–2010 vs. 49 (80.3%) in 2011–2014 vs. 145 (85.4%) during the period 2015–2019 (<i>p</i>-value = 0.41). Age discrepancy between the clinical trial population and the real-world population was higher for studies that did not report race (mean difference −8.8 years (95% CI −12.6 to −5.0 years)) vs. studies that did report it (mean difference −5.1 years, (95% CI −6.4 to −3.7 years), <i>p</i>-value = 0.04). Conclusion: The study demonstrates that a significant number of clinical trials leading to cancer drug approvals suffer from racial and age disparity when compared to real-world populations, and that the two factors may be interrelated. We recommend continued efforts to recruit diverse populations.
format	article
author	Thejus Jayakrishnan Sonikpreet Aulakh Mizba Baksh Kianna Nguyen Meghna Ailawadhi Ayesha Samreen Ricardo Parrondo Taimur Sher Vivek Roy Rami Manochakian Aneel Paulus Asher Chanan-Khan Sikander Ailawadhi
author_facet	Thejus Jayakrishnan Sonikpreet Aulakh Mizba Baksh Kianna Nguyen Meghna Ailawadhi Ayesha Samreen Ricardo Parrondo Taimur Sher Vivek Roy Rami Manochakian Aneel Paulus Asher Chanan-Khan Sikander Ailawadhi
author_sort	Thejus Jayakrishnan
title	Landmark Cancer Clinical Trials and Real-World Patient Populations: Examining Race and Age Reporting
title_short	Landmark Cancer Clinical Trials and Real-World Patient Populations: Examining Race and Age Reporting
title_full	Landmark Cancer Clinical Trials and Real-World Patient Populations: Examining Race and Age Reporting
title_fullStr	Landmark Cancer Clinical Trials and Real-World Patient Populations: Examining Race and Age Reporting
title_full_unstemmed	Landmark Cancer Clinical Trials and Real-World Patient Populations: Examining Race and Age Reporting
title_sort	landmark cancer clinical trials and real-world patient populations: examining race and age reporting
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/4902baa6ea224b818c6a583586ed5b2c
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Landmark Cancer Clinical Trials and Real-World Patient Populations: Examining Race and Age Reporting

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