Background: Clinical trials should benefit all people. Consequently, the National Cancer Institute expects cancer centers to accrue individuals to clinical trials in proportion to the cancer burden experienced by populations that live in their respective catchment areas; unfortunately, many cancer centers fail to meet this expectation. The person who gives consent for individuals in clinical trials frequently has significant contact with potential trial participants. We hypothesized that the race, ethnicity, and language of the consenter may have an important bearing on whether an individual chooses to participate in a clinical trial. Methods: We used mixed methods to investigate the impact of the socio-cultural background of the consenter on the decision of a potential research subject to participate in a clinical trial. Between 01/2018 and 02/2020, 205 women were approached in the sequential order they appeared in our breast clinic; of the 181 participants who agreed to complete the survey questionnaire, 94 (52%) were Northern European, non-Hispanic White (NE White), and 87 (48%) were Women-of-Color (WOC); this category includes participants who self-identified as Asian, Black, Hispanic/Latina, or Native American. Results: There were statistically significant differences according to the importance of the consenter’s characteristics in the decision to enroll or decline participation in the BCT. No NE White enroller (0%,n= 0) reported that consenter race was important versus 11% (n= 9) of WOC enrollers (p= 0.0009). Similarly, none of the NE White enrollers rated the consenter “looking like people in my community” as important versus 12% (n= 10) of the WOC enrollers (p= 0.0004). Conclusions: We find that consenter race and ethnicity are important for clinical trial diversity. Larger studies are needed to evaluate the generalizability of this finding.
背景：临床试验应惠及所有人。因此，美国国家癌症研究所期望各癌症中心招募的临床试验参与者比例与其服务区域内的癌症负担人口构成相匹配；然而，许多癌症中心未能达到这一预期。临床试验的知情同意者常与潜在参与者有密切接触。我们假设知情同意者的种族、民族和语言可能对个体是否选择参与临床试验产生重要影响。 方法：我们采用混合研究方法，探讨知情同意者的社会文化背景对潜在研究对象参与临床试验决策的影响。2018年1月至2020年2月期间，按就诊顺序对乳腺门诊的205名女性进行招募；在同意完成调查问卷的181名参与者中，94人（52%）为北欧非西班牙裔白人（NE白人），87人（48%）为有色人种女性（WOC）；该类别包括自我认同为亚裔、黑人、西班牙裔/拉丁裔或美洲原住民的参与者。 结果：在决定是否参与乳腺癌临床试验时，知情同意者特征的重要性存在统计学显著差异。没有NE白人参与者（0%，n=0）认为知情同意者的种族重要，而11%（n=9）的WOC参与者认为重要（p=0.0009）。同样，没有NE白人参与者认为知情同意者"与我社区人群相似"重要，而12%（n=10）的WOC参与者认为重要（p=0.0004）。 结论：我们发现知情同意者的种族和民族特征对临床试验多样性具有重要影响。需要更大规模的研究来评估这一发现的普适性。
Mixed-Methods Approach: Impact of Clinical Consenter Diversity on Clinical Trials Enrollment
肿瘤(癌症)患者之家