Natalie P Bransky, Anne M Walling, Alexandra M Klomhaus, John A Glaspy, Maria D Garcia-Jimenez
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引用次数: 0
Abstract
Purpose: The perspective of all stakeholders involved in clinical trials is critical to addressing disparities in racial/ethnic minority (REM) clinical trial participation. Little is known about clinical trial investigator perspectives. To our knowledge, there are no published studies assessing differences in investigator perspectives on the basis of their primary role in clinical trials (ie, principal investigator [PI] or subinvestigator [sub-I]). Differences likely exist in investigator perspectives on the basis of having a more design-oriented (PI) or recruitment-oriented (sub-I) role.
Materials and methods: We conducted a cross-sectional, anonymous, pilot survey of 107 oncology clinical trial investigators at an academic center. The survey assessed five domains about disparities in REM clinical trial participation. We performed a subgroup analysis of mid- and late-career investigators (≥10 years of experience) comparing PIs (opened ≥one clinical trial in the past year) with sub-Is (did not).
Results: Among 60 respondents, a majority (83%) strongly agreed disparities exist in REM clinical trial participation and that this is problematic (75%). Notably, 45% agreed they cannot directly address this problem. In the subgroup analysis, PIs were more likely to have received training about barriers/facilitators to REM clinical trial participation and strategies to increase participation. They were also more likely to endorse wanting help in this area.
Conclusion: Our results suggest clinical trial investigators are aware of disparities in REM clinical trial participation but do not feel they can address them. PIs are more likely to have received previous training on this topic and to want help to improve their ability to address disparities. More studies are needed to inform targeted interventions and structural improvements to enhance investigators' self-efficacy for improving REM participation in oncology clinical trials.
目的:参与临床试验的所有利益相关者的观点对于解决少数种族/族裔(REM)临床试验参与方面的差异至关重要。人们对临床试验研究者的观点知之甚少。据我们所知,目前还没有公开发表的研究对研究者在临床试验中的主要角色(即主要研究者[PI]或次级研究者[sub-I])的视角差异进行评估。研究者的观点可能因其角色更偏向于设计(PI)或招募(sub-I)而存在差异:我们对一家学术中心的 107 名肿瘤临床试验研究者进行了一项横断面匿名试点调查。该调查评估了有关 REM 临床试验参与差异的五个领域。我们对职业生涯中期和晚期的研究人员(工作经验≥10年)进行了分组分析,比较了PIs(在过去一年中开设了≥一项临床试验)和sub-Is(未开设临床试验):在 60 位受访者中,大多数人(83%)强烈同意在 REM 临床试验参与方面存在差异,并认为这是个问题(75%)。值得注意的是,45% 的受访者认为他们无法直接解决这一问题。在分组分析中,首席研究员更有可能接受过有关 REM 临床试验参与障碍/促进因素以及提高参与率策略的培训。他们也更有可能希望在这方面得到帮助:我们的研究结果表明,临床试验研究者意识到了 REM 临床试验参与方面的差异,但认为他们无法解决这些问题。临床试验研究者更有可能以前接受过这方面的培训,也更有可能希望得到帮助,以提高他们解决差异问题的能力。我们需要进行更多的研究,为有针对性的干预措施和结构改进提供信息,以提高研究者的自我效能,从而改善 REM 参与肿瘤临床试验的情况。