Barriers to therapeutic clinical trials enrollment: differences between African-American and white cancer patients identified at the time of eligibility assessment.
Barriers to therapeutic clinical trials enrollment: differences between African-American and white cancer patients identified at the time of eligibility assessment.
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DOI：
10.1177/1740774512458992
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发表时间：
2012-12
期刊：
影响因子：
--
通讯作者：
Siminoff LA
中科院分区：
文献类型：
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作者：
Penberthy L;Brown R;Wilson-Genderson M;Dahman B;Ginder G;Siminoff LA
临床试验（CT）是将研究转化为护理标准的机制。在服务不足和少数民族人口中招募率低可能导致在获得最新技术和治疗方面的不公平，损害普遍性，并导致无法在代表性不足的人口中确定重要的积极或消极治疗效果。在39个月的时间内收集了关于患者是否有资格进行可用的治疗性癌症CT的数据。收集不合格和拒绝的原因。使用自动化软件工具采集数据，用于跟踪入组前的合格性。我们检查了与试验评估相关的特征，以及不合格和拒绝的原因，总体和患者种族。非洲裔美国人（AA）比白人更可能不符合条件（比值比，（OR）= 1.26，95%置信区间（CI）= 1.0-1.58），如果符合条件，拒绝参与（OR = 1.79，95% CI = 1.27-2.52），即使在调整保险，年龄，性别，研究阶段和癌症类型后。白色患者更可能由于研究特异性或癌症特征而不合格。AA更有可能是不合格的，由于精神状态或感知不遵守。白人更有可能由于额外的负担，由于对随机化和毒性的担忧，或者因为他们表达了积极的治疗偏好而拒绝。AA更有可能拒绝，因为他们对CT不感兴趣，因为家庭压力，或者他们感到不知所措（NS））。这项研究是第一个直接比较不合格和拒绝率和原因前瞻性地捕获AA和白色癌症患者。这些数据与早期的研究一致，这些研究表明AA患者更经常被认为不符合条件，并且在符合条件时，更经常拒绝参与。然而，种族的不合格和拒绝的原因的差异对癌症中心参与适合于所服务的患者群体的CT有影响。在更广泛的范围内，应考虑修改资格标准和其他设计方面，以使少数群体和其他得不到充分服务的群体能够更广泛地参与。
Clinical trials (CTs) are the mechanism by which research is translated into standards of care. Low recruitment among underserved and minority populations may result in inequity in access to the latest technology and treatments, compromise the generalizability, and lead to failure in identification of important positive or negative treatment effects among under-represented populations. Data were collected over a 39-month period on patient eligibility for available therapeutic cancer CTs. Reasons for ineligibility and refusal were collected. The data were captured using an automated software tool for tracking eligibility pre-enrollment. We examined characteristics associated with being evaluated for a trial, and reasons for ineligibility and refusal, overall and by patient race. African-Americans (AAs) were more likely than Whites to be ineligible (odds ratio, (OR) = 1.26, 95% confidence interval (CI) = 1.0–1.58) and if eligible, to refuse participation (OR = 1.79, 95% CI = 1.27–2.52), even after adjusting for insurance, age, gender, study phase, and cancer type. White patients were more likely to be ineligible due to study-specific or cancer characteristics. AAs were more likely to be ineligible due to mental status or perceived noncompliance. Whites were more likely to refuse due to extra burden, due to concerns with randomization and toxicity, or because they express a positive treatment preference. AAs were more likely to refuse because they were not interested in CTs, because of family pressures, or they felt overwhelmed (NS)). This study is the first to directly compare ineligibility and refusal rates and reasons captured prospectively in AA and White cancer patients. The data are consistent with earlier studies that indicated that AA patients more often are deemed ineligible and, when eligible, more often refuse participation. However, differences in reasons for ineligibility and refusal by race have implications for a cancer center to participate in CTs appropriate for the population of patients served. On a broader scale, consideration should be given to modifying eligibility criteria and other design aspects to permit broader participation of minority and other underserved groups.