Eligibility Criteria Perpetuate Disparities in Enrollment and Participation of Black Patients in Pancreatic Cancer Clinical Trials.
Eligibility Criteria Perpetuate Disparities in Enrollment and Participation of Black Patients in Pancreatic Cancer Clinical Trials.
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DOI：
10.1200/jco.21.02492
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发表时间：
2022-07-10
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临床试验确定癌症治疗的安全性和有效性，并建立护理标准。少数族裔患者参与癌症临床试验的情况令人沮丧。我们的目的是确定资格标准对胰腺导管腺癌（PDAC）临床试验候选资格差异的影响。传统的PDAC试验资格标准从ClinicalTrials.gov获得。纳入了2010年至2019年在弗吉尼亚联邦大学健康中心寻求治疗的PDAC患者。临床数据是从电子病历中的账单代码和离散值中获得的。使用卡方检验和基于无条件最大似然的比值比确定种族组之间的资格标准差异。在676例患者中，大多数为黑人或白人（分别为42.5%和51.6%）。使用传统标准，黑人患者比白人患者（42.4% v 33.2%, P = 0.023）更有可能不符合参与条件，继发于低白蛋白血症（14.1% v 7.9%, P = 0.023）、艾滋病（3.1% v 0.3%, P = 0.010）、乙肝（1.7% v 0%, P = 0.043）和丙型肝炎（9.1% v 3.4%, P = 0.005）。黑人患者也更有可能因为肾功能不全、近期冠状动脉支架植入和未控制的糖尿病而不符合条件。既往癌症治疗排除黑人患者少于白人患者（9.1% vs 14.0%, P = 0.072），主要归因于接受新辅助化疗的比例较低。战略性资格标准修订可以使黑人和白人患者的不合格率相等（26.8% vs 24.8%, P = .581）。传统的资格标准不同地排除了黑人患者参加PDAC临床试验。这些标准使差异永久化，限制了普遍性，而且往往没有医学上的合理性。修订后的标准可以改善参与者的多样性，但不会影响安全性或研究结果。
Clinical trials determine safety and efficacy of cancer therapeutics and establish standards of care. Minority patient participation in cancer clinical trials is dismal. We aimed to determine the impact of eligibility criteria on disparities in pancreatic ductal adenocarcinoma (PDAC) clinical trial candidacy. Traditional PDAC trial eligibility criteria were obtained from ClinicalTrials.gov. Patients with PDAC who sought care at Virginia Commonwealth University Health from 2010 to 2019 were included. Clinical data were obtained from billing codes and discrete values in the electronic medical record. Eligibility criteria differences between racial groups were determined using chi-squared tests and unconditional maximum likelihood-based odds ratios. Among 676 patients, most identified as Black or White race (42.5% and 51.6%, respectively). Using traditional criteria, Black patients were more likely to be ineligible for participation compared with White patients (42.4% v 33.2%, P = .023) secondary to hypoalbuminemia (14.1% v 7.9%, P = .023), HIV (3.1% v 0.3%, P = .010), hepatitis B (1.7% v 0%, P = .043), and hepatitis C (9.1% v 3.4%, P = .005). Black patients were also numerically more likely to be ineligible because of renal dysfunction, recent coronary stenting, and uncontrolled diabetes mellitus. Prior cancer treatment excluded fewer Black than White patients (9.1% v 14.0%, P = .072), most attributable to lower rates of neoadjuvant chemotherapy received. Strategic eligibility criteria revisions could equalize ineligibility rates between Black and White patients (26.8% v 24.8%, P = .581). Traditional eligibility criteria differentially exclude Black patients from participating in PDAC clinical trials. These criteria perpetuate disparities, limit generalizability, and are often not medically justifiable. Revised criteria may improve participant diversity, without compromising safety or study results.