少数民族参与临床试验:增加可及性的途径。

Minority Enrollment to Clinical Trials: Road to Increased Access.

机构信息

Division of Oncology & Hematology, University of Nebraska Medical Center, Omaha, Nebraska.

出版信息

Oncology (Williston Park). 2021 Mar 15;35(3):107. doi: 10.46883/ONC.2021.3503.0107.

Abstract

For the outcome of clinical trials to have validity, participants should represent the patients that will be using the medical products, though this is often not the case. Racial and ethnic minorities are underrepresented in cancer clinical trials for a variety of reasons. This is a concern because people of different ages, races, and ethnicities may react differently to medical products. The estimated extent of racial disparities in clinical trial access varies in the literature, yet recent reports-such as the FDA's 2018 Drug Trials Snapshots-indicate the presence of a remarkable imbalance. A total of 5157 patients participated in oncology trials that led to approvals of 17 new drugs. Overall, 38% of all participants were women, 68% were White, 15% were Asian, 4% were Black or African American, 4% were Hispanic, and 50% were 65 years and older.1 These proportions sharply contrast with the racial distribution in the general United States population (76.6% White, 13.4% Black or African American, 5.8% Asian, 18.1% Hispanic or Latino). Further, only 36% of the trial participants were residents in the United States, which is a reflection of the increasingly international nature of phase 3 oncology trials designed to support the worldwide marketing plans of the study sponsor. According to US Census Bureau projections, more than half of the population in the United States is expected to be other than non-Hispanic White by 2045.2 In the absence of proactive planning, corrective measures, and systematic and effective intervention, the disparity between the clinical trial population and the changing population of patients with cancer in the United States is likely to worsen in the coming decades. What can be done to reverse this trend and enhance clinical trial enrollment by minorities? Increasing minority representation in the health care professions will enhance the ability of the patients to feel more comfortable with the recommended options, including clinical trial participation. In addition, the outreach of health care opportunities to neighborhoods closer to patients' homes will allow access to those without consistent transportation. Eligibility criteria that allow for patients with more co-morbidities to enroll when possible will also increase minority enrollment as well as represent a more real-world population on the study. Another recent improvement is the congressional approval of the Clinical Treatment Act, which requires Medicaid to cover the routine clinical care costs of patients associated with participation in clinical trials. Since Medicaid serves a large portion of individuals from racial and ethnic minority groups, this legislation will remove some barriers to participation in clinical trials for this patient population. With a more representative patient population, the results of these clinical trials will have more accurate outcomes in real-world patients with the illness in question. In addition, the racial and ethnic minority groups will benefit with this increased access to clinical trials and cutting-edge health care opportunities.

摘要

为了使临床试验的结果具有有效性,参与者应该代表将使用医疗产品的患者,尽管这种情况并不常见。出于各种原因,少数族裔在癌症临床试验中的代表性不足。这是一个令人担忧的问题,因为不同年龄、种族和族裔的人可能对医疗产品有不同的反应。文献中报告的临床试验准入方面的种族差异程度各不相同,但最近的报告(如 FDA 的 2018 年药物试验快照)表明存在显著的不平衡。共有 5157 名患者参加了导致 17 种新药获批的肿瘤学试验。总体而言,所有参与者中有 38%是女性,68%是白人,15%是亚洲人,4%是黑人或非裔美国人,4%是西班牙裔或拉丁裔,50%是 65 岁及以上的人。1 这些比例与美国一般人口的种族分布(白人占 76.6%,黑人或非裔美国人占 13.4%,亚洲人占 5.8%,西班牙裔或拉丁裔占 18.1%)形成鲜明对比。此外,只有 36%的试验参与者是美国居民,这反映了旨在支持研究赞助商全球营销计划的第 3 阶段肿瘤学试验日益国际化。根据美国人口普查局的预测,到 2045 年,预计美国超过一半的人口将是非西班牙裔白人。2 在没有积极规划、纠正措施和系统有效的干预措施的情况下,临床试验人群与美国癌症患者人口变化之间的差距可能会在未来几十年恶化。为了扭转这一趋势并增加少数族裔的临床试验参与人数,可以采取哪些措施?增加医疗保健专业人员中的少数族裔代表人数,将增强患者对推荐方案的接受程度,包括参与临床试验。此外,向离患者家更近的社区提供医疗保健机会,将使那些没有固定交通工具的人也能获得这些机会。在可能的情况下,纳入患有更多合并症的患者的资格标准也将增加少数族裔的参与率,并代表研究中的更真实人群。最近的另一个改进是国会批准了《临床治疗法案》,该法案要求医疗补助计划覆盖与参与临床试验相关的患者的常规临床护理费用。由于医疗补助计划服务于大量来自少数族裔的个人,因此该立法将为这一患者群体参与临床试验消除一些障碍。通过更具代表性的患者群体,这些临床试验的结果将在患有相关疾病的真实世界患者中具有更准确的结果。此外,少数族裔群体将受益于增加对临床试验和最先进的医疗保健机会的参与。

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