Lorena Kuri, Sagar Setru, Gengyuan Liu, Diane Moniz Reed, David Weigand, Aparna Surampudi, Susan Berger, David Paulucci, Angshu Rai, Venkat Sethuraman, Blythe Vito, Helen Kellar-Wood, Mariann Micsinai Balan
{"title":"在Bristol Myers squibb赞助的美国肿瘤临床试验中增加患者多样性的数据驱动策略。","authors":"Lorena Kuri, Sagar Setru, Gengyuan Liu, Diane Moniz Reed, David Weigand, Aparna Surampudi, Susan Berger, David Paulucci, Angshu Rai, Venkat Sethuraman, Blythe Vito, Helen Kellar-Wood, Mariann Micsinai Balan","doi":"10.1177/17407745231180506","DOIUrl":null,"url":null,"abstract":"<p><strong>Background/aims: </strong>Determining whether clinical trial findings are applicable to diverse, real-world patient populations can be challenging when the full demographic characteristics of enrolled patients are not consistently reported. Here, we present the results of a descriptive analysis of racial and ethnic demographic information for patients in Bristol Myers Squibb (BMS)-sponsored oncology trials in the United States (US) and describe factors associated with increased patient diversity.</p><p><strong>Methods: </strong>BMS-sponsored oncology trials conducted at US sites with study enrollment dates between 1 January 2013 and 31 May 2021 were analyzed. Patient race/ethnicity information was self-reported in case report forms. As principal investigators (PIs) did not report their own race/ethnicity, a deep-learning algorithm (ethnicolr) was used to predict PI race/ethnicity. Trial sites were linked to counties to understand the role of county-level demographics. The impact of working with patient advocacy and community-based organizations to increase diversity in prostate cancer trials was analyzed. The magnitude of associations between patient diversity and PI diversity, US county demographics, and recruitment interventions in prostate cancer trials were assessed by bootstrapping.</p><p><strong>Results: </strong>A total of 108 trials for solid tumors were analyzed, including 15,763 patients with race/ethnicity information and 834 unique PIs. Of the 15,763 patients, 13,968 (89%) self-reported as White, 956 (6%) Black, 466 (3%) Asian, and 373 (2%) Hispanic. Among 834 PIs, 607 (73%) were predicted to be White, 17 (2%) Black, 161 (19%) Asian, and 49 (6%) Hispanic. A positive concordance was observed between Hispanic patients and PIs (mean = 5.9%; 95% confidence interval (CI) = 2.4, 8.9), a less positive concordance between Black patients and PIs (mean = 1.0%; 95% CI = -2.7, 5.5), and no concordance between Asian patients and PIs. Geographic analyses showed that more non-White patients enrolled in study sites in counties with higher proportions of non-White residents (e.g. a county population that was 5%-30% Black had 7%-14% more Black patients enrolled in study sites). Following purposeful recruitment efforts in prostate cancer trials, 11% (95% CI = 7.7, 15.3) more Black men enrolled in prostate cancer trials.</p><p><strong>Conclusion: </strong>Most patients in these clinical trials were White. PI diversity, geographic diversity, and recruitment efforts were related to greater patient diversity. This report constitutes an essential step in benchmarking patient diversity in BMS US oncology trials and enables BMS to understand which initiatives may increase patient diversity. While complete reporting of patient characteristics such as race/ethnicity is critical, identifying diversity improvement tactics with the highest impact is essential. Strategies with the greatest concordance to clinical trial patient diversity should be implemented to make meaningful improvements to the diversity of clinical trial populations.</p>","PeriodicalId":10685,"journal":{"name":"Clinical Trials","volume":null,"pages":null},"PeriodicalIF":2.2000,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10638849/pdf/","citationCount":"0","resultStr":"{\"title\":\"Data-driven strategies for increasing patient diversity in Bristol Myers Squibb-sponsored US oncology clinical trials.\",\"authors\":\"Lorena Kuri, Sagar Setru, Gengyuan Liu, Diane Moniz Reed, David Weigand, Aparna Surampudi, Susan Berger, David Paulucci, Angshu Rai, Venkat Sethuraman, Blythe Vito, Helen Kellar-Wood, Mariann Micsinai Balan\",\"doi\":\"10.1177/17407745231180506\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background/aims: </strong>Determining whether clinical trial findings are applicable to diverse, real-world patient populations can be challenging when the full demographic characteristics of enrolled patients are not consistently reported. Here, we present the results of a descriptive analysis of racial and ethnic demographic information for patients in Bristol Myers Squibb (BMS)-sponsored oncology trials in the United States (US) and describe factors associated with increased patient diversity.</p><p><strong>Methods: </strong>BMS-sponsored oncology trials conducted at US sites with study enrollment dates between 1 January 2013 and 31 May 2021 were analyzed. Patient race/ethnicity information was self-reported in case report forms. As principal investigators (PIs) did not report their own race/ethnicity, a deep-learning algorithm (ethnicolr) was used to predict PI race/ethnicity. Trial sites were linked to counties to understand the role of county-level demographics. The impact of working with patient advocacy and community-based organizations to increase diversity in prostate cancer trials was analyzed. The magnitude of associations between patient diversity and PI diversity, US county demographics, and recruitment interventions in prostate cancer trials were assessed by bootstrapping.</p><p><strong>Results: </strong>A total of 108 trials for solid tumors were analyzed, including 15,763 patients with race/ethnicity information and 834 unique PIs. Of the 15,763 patients, 13,968 (89%) self-reported as White, 956 (6%) Black, 466 (3%) Asian, and 373 (2%) Hispanic. Among 834 PIs, 607 (73%) were predicted to be White, 17 (2%) Black, 161 (19%) Asian, and 49 (6%) Hispanic. A positive concordance was observed between Hispanic patients and PIs (mean = 5.9%; 95% confidence interval (CI) = 2.4, 8.9), a less positive concordance between Black patients and PIs (mean = 1.0%; 95% CI = -2.7, 5.5), and no concordance between Asian patients and PIs. Geographic analyses showed that more non-White patients enrolled in study sites in counties with higher proportions of non-White residents (e.g. a county population that was 5%-30% Black had 7%-14% more Black patients enrolled in study sites). Following purposeful recruitment efforts in prostate cancer trials, 11% (95% CI = 7.7, 15.3) more Black men enrolled in prostate cancer trials.</p><p><strong>Conclusion: </strong>Most patients in these clinical trials were White. PI diversity, geographic diversity, and recruitment efforts were related to greater patient diversity. This report constitutes an essential step in benchmarking patient diversity in BMS US oncology trials and enables BMS to understand which initiatives may increase patient diversity. While complete reporting of patient characteristics such as race/ethnicity is critical, identifying diversity improvement tactics with the highest impact is essential. 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引用次数: 0
摘要
背景/目的:当入组患者的全部人口学特征没有一致报告时,确定临床试验结果是否适用于不同的、现实世界的患者群体是具有挑战性的。在这里,我们提出了一项描述性分析的结果,分析了在美国布里斯托尔施贵宝(BMS)赞助的肿瘤试验中患者的种族和民族人口统计信息,并描述了与患者多样性增加相关的因素。方法:对2013年1月1日至2021年5月31日期间在美国进行的bms赞助的肿瘤试验进行分析。患者的种族/民族信息在病例报告表格中自我报告。由于主要研究者(PI)没有报告自己的种族/民族,因此使用深度学习算法(ethnicolr)来预测PI的种族/民族。试验地点与县相联系,以了解县级人口统计的作用。分析了与患者倡导和社区组织合作增加前列腺癌试验多样性的影响。通过自举法评估前列腺癌试验中患者多样性和PI多样性、美国县人口统计和招募干预之间的关联程度。结果:共分析了108项实体瘤试验,包括15763例具有种族/民族信息的患者和834例独特的pi。在15763例患者中,13968例(89%)为白人,956例(6%)为黑人,466例(3%)为亚洲人,373例(2%)为西班牙人。在834名pi中,白人607人(73%),黑人17人(2%),亚裔161人(19%),西班牙裔49人(6%)。西班牙裔患者与pi之间存在正一致性(平均= 5.9%;95%可信区间(CI) = 2.4, 8.9),黑人患者与pi之间的一致性不太积极(平均值= 1.0%;95% CI = -2.7, 5.5),亚洲患者和pi之间没有一致性。地理分析表明,在非白人居民比例较高的县,更多的非白人患者入组研究站点(例如,一个县的人口中有5%-30%是黑人,则有7%-14%的黑人患者入组研究站点)。在前列腺癌试验中有目的的招募后,11% (95% CI = 7.7, 15.3)的黑人男性加入了前列腺癌试验。结论:本组临床试验患者以白人居多。PI多样性、地理多样性和招募工作与更大的患者多样性有关。该报告是BMS美国肿瘤试验中对患者多样性进行基准测试的重要一步,使BMS能够了解哪些举措可以增加患者多样性。虽然完整报告患者的种族/民族等特征至关重要,但确定具有最大影响的多样性改进策略至关重要。应实施与临床试验患者多样性最一致的策略,以使临床试验人群的多样性得到有意义的改善。
Data-driven strategies for increasing patient diversity in Bristol Myers Squibb-sponsored US oncology clinical trials.
Background/aims: Determining whether clinical trial findings are applicable to diverse, real-world patient populations can be challenging when the full demographic characteristics of enrolled patients are not consistently reported. Here, we present the results of a descriptive analysis of racial and ethnic demographic information for patients in Bristol Myers Squibb (BMS)-sponsored oncology trials in the United States (US) and describe factors associated with increased patient diversity.
Methods: BMS-sponsored oncology trials conducted at US sites with study enrollment dates between 1 January 2013 and 31 May 2021 were analyzed. Patient race/ethnicity information was self-reported in case report forms. As principal investigators (PIs) did not report their own race/ethnicity, a deep-learning algorithm (ethnicolr) was used to predict PI race/ethnicity. Trial sites were linked to counties to understand the role of county-level demographics. The impact of working with patient advocacy and community-based organizations to increase diversity in prostate cancer trials was analyzed. The magnitude of associations between patient diversity and PI diversity, US county demographics, and recruitment interventions in prostate cancer trials were assessed by bootstrapping.
Results: A total of 108 trials for solid tumors were analyzed, including 15,763 patients with race/ethnicity information and 834 unique PIs. Of the 15,763 patients, 13,968 (89%) self-reported as White, 956 (6%) Black, 466 (3%) Asian, and 373 (2%) Hispanic. Among 834 PIs, 607 (73%) were predicted to be White, 17 (2%) Black, 161 (19%) Asian, and 49 (6%) Hispanic. A positive concordance was observed between Hispanic patients and PIs (mean = 5.9%; 95% confidence interval (CI) = 2.4, 8.9), a less positive concordance between Black patients and PIs (mean = 1.0%; 95% CI = -2.7, 5.5), and no concordance between Asian patients and PIs. Geographic analyses showed that more non-White patients enrolled in study sites in counties with higher proportions of non-White residents (e.g. a county population that was 5%-30% Black had 7%-14% more Black patients enrolled in study sites). Following purposeful recruitment efforts in prostate cancer trials, 11% (95% CI = 7.7, 15.3) more Black men enrolled in prostate cancer trials.
Conclusion: Most patients in these clinical trials were White. PI diversity, geographic diversity, and recruitment efforts were related to greater patient diversity. This report constitutes an essential step in benchmarking patient diversity in BMS US oncology trials and enables BMS to understand which initiatives may increase patient diversity. While complete reporting of patient characteristics such as race/ethnicity is critical, identifying diversity improvement tactics with the highest impact is essential. Strategies with the greatest concordance to clinical trial patient diversity should be implemented to make meaningful improvements to the diversity of clinical trial populations.
期刊介绍:
Clinical Trials is dedicated to advancing knowledge on the design and conduct of clinical trials related research methodologies. Covering the design, conduct, analysis, synthesis and evaluation of key methodologies, the journal remains on the cusp of the latest topics, including ethics, regulation and policy impact.