Division of Health Policy and Economics, Department of Population Health Sciences, Weill Medical College, Cornell University, New York, NY.
Center for Health Equity, Cornell University, New York, NY.
J Clin Oncol. 2024 Sep 20;42(27):3238-3246. doi: 10.1200/JCO.23.01149. Epub 2024 Jul 25.
It is unknown whether Medicaid expansion under the Affordable Care Act (ACA) or state-level policies mandating Medicaid coverage of the routine costs of clinical trial participation have ameliorated longstanding racial and ethnic disparities in cancer clinical trial enrollment.
We conducted a retrospective, cross-sectional difference-in-differences analysis examining the effect of Medicaid expansion on rates of enrollment for Black or Hispanic nonelderly adults in nonobservational, US cancer clinical trials using data from Medidata's Rave platform for 2012-2019. We examined heterogeneity in this effect on the basis of whether states had pre-existing mandates requiring Medicaid coverage of the routine costs of clinical trial participation.
The study included 47,870 participants across 1,353 clinical trials and 344 clinical trial sites. In expansion states, the proportion of participants who were Black or Hispanic increased from 16.7% before expansion to 17.2% after Medicaid expansion (0.5 percentage point [PP] change [95% CI, -1.1 to 2.0]). In nonexpansion states, this proportion increased from 19.8% before 2014 (when the first states expanded eligibility under the ACA) to 20.4% after 2014 (0.6 PP change [95% CI, -2.3 to 3.5]). These trends yielded a nonsignificant difference-in-differences estimate of 0.9 PP (95% CI, -2.6 to 4.4). Medicaid expansion was associated with a 5.3 PP (95% CI, 1.9 to 8.7) increase in the enrollment of Black or Hispanic participants in states with mandates requiring Medicaid coverage of the routine costs of trial participation, but not in states without mandates (-0.3 PP [95% CI, -4.5 to 3.9]).
Medicaid expansion was not associated with a significant increase in the proportion of Black or Hispanic oncology trial participants overall, but was associated with an increase specifically in states that mandated Medicaid coverage of the routine costs of trial participation.
尚不清楚《平价医疗法案》(ACA)下的医疗补助扩大范围,还是要求医疗补助覆盖临床试验常规费用的州级政策,改善了癌症临床试验参与方面长期存在的种族和民族差异。
我们采用 Medidata 的 Rave 平台在 2012 年至 2019 年期间收集的数据,进行了一项回顾性、横断面差异分差分析,以评估医疗补助扩大范围对非观察性、美国癌症临床试验中黑人或西班牙裔非老年成年人入组率的影响。我们根据各州是否有要求医疗补助覆盖临床试验常规费用的事先授权,研究了这种影响的异质性。
该研究纳入了来自 1353 项临床试验和 344 个临床试验站点的 47870 名参与者。在扩大医疗补助范围的州,黑人或西班牙裔参与者的比例从扩大前的 16.7%增加到扩大后的 17.2%(0.5 个百分点[95%CI,-1.1 至 2.0])。在未扩大医疗补助范围的州,这一比例从 2014 年(第一批州扩大 ACA 下的资格)前的 19.8%增加到 2014 年后的 20.4%(0.6 个百分点[95%CI,-2.3 至 3.5])。这些趋势产生了一个无统计学意义的差异估计值为 0.9 个百分点(95%CI,-2.6 至 4.4)。在要求医疗补助覆盖临床试验常规费用的州,医疗补助扩大与黑人或西班牙裔参与者入组率增加 5.3 个百分点(95%CI,1.9 至 8.7)相关,但在没有此类授权的州,这一比例没有变化(-0.3 个百分点[95%CI,-4.5 至 3.9])。
医疗补助扩大与总体上黑人或西班牙裔肿瘤试验参与者比例的显著增加无关,但与要求医疗补助覆盖临床试验常规费用的州相关。