Disparities in the Availability of Cancer Clinical Trials: A Multi-level Analysis

癌症临床试验可获得性的差异：多水平分析 少数群体参与癌症临床试验对于确保 所产生的结果促进了新疗法和治疗反应的发现， 特别是与传统上代表性不足的人口有关，并确保公平获得 新的有前途的治疗方法。然而，在国会授权20多年后， 国家卫生研究院确保少数群体“充分和适当”参与临床研究， 许多少数民族人口的参与率仍然大大低于 占美国总人口的获得癌症临床试验的差异是癌症治疗的主要障碍。 减少参与审判的差异。因此，了解地理位置的作用至关重要。 如果我们要设计和分析癌症临床试验， 有针对性地采取有效干预措施，以改善少数群体对此类审判的参与。先前的研究 在梳理现场和医疗保健系统层面的复杂组合方面取得的成功有限 影响不同类型的癌症临床试验对少数群体的可用性的因素 人口主要有两个原因。首先，我们目前缺乏一个全面的数据库， 充分详细的试验层面特征或关于试验地点的信息 由于难以综合来自多个来源的此类信息， 传统的记录连接方法。因此，以前的研究评估的差异，在可用性 癌症临床试验在检查的因素范围和 研究试验的数量和类型。其次，癌症临床试验通常在多个 在大型医疗保健系统内运营的网站，以及个人招聘网站， 参与多项试验，这对解开 各种试验、研究中心和医疗保健系统水平因素对癌症临床 试用可用性。我们建议通过整合以下信息来应对这些挑战： 使用先进的记录链接方法和应用复杂的建模 技术来分析产生的多级数据。拟议的研究将改善 了解癌症临床试验的可用性在不同地理环境中的差异 和临床试验组合，这可以帮助有针对性的干预措施和政策，以解决 在进入最需要的地区方面存在差距。该项目还将奠定科学 为计划的未来研究奠定基础，以预测传统上患者人群的入组情况 在公共资助的癌症临床试验的临床研究中代表性不足。

Disparities in the Availability of Cancer Clinical Trials: A Multi-level Analysis Participation of minority populations in cancer clinical trials is vital to ensure generalizability of the results generated, facilitate discovery of novel therapies and therapeutic responses that are particularly relevant to traditionally underrepresented populations, and ensure equitable access to new and promising treatments. Yet more than twenty years after Congress mandated that the NIH ensure `sufficient and appropriate' participation of minorities in clinical research, the participation rate of many minority populations remains substantially lower than the composition of the overall US population. Disparities in access to cancer clinical trials are a chief barrier to reducing disparities in trial participation. Thus it is critical to understand the role that geographic variation plays in driving disparities in access to cancer clinical trials if we are to design and target effective interventions to improve minority participation in such trials. Prior studies have had limited success in teasing apart the complex mix of site- and health care system-level factors that influence the availability of different types of cancer clinical trials for minority populations for two chief reasons. First, we currently lack a comprehensive database of sufficiently detailed trial-level characteristics or information about the locations where trials are launched because of the difficulty in synthesizing such information from multiple sources using traditional record linkage methods. As such, prior studies evaluating disparities in the availability of cancer clinical trials have been importantly limited in the range of factors examined and the number and type of trials studied. Second, cancer clinical trials are often launched at multiple sites that operate within larger healthcare systems, and individual recruiting sites often participate in multiple trials, which pose methodological challenges to disentangling the associations between various trial-, site-, and health care system-level factors on cancer clinical trial availability. We propose to address these challenges by integrating information from multiple sources using advanced record linkage methods and applying sophisticated modeling techniques to analyze the resulting multilevel data. The proposed study will improve understanding of how the availability of cancer clinical trials varies across geographic settings and the clinical trials portfolio, which could help target interventions and policies to address disparities in access to the areas most in need. This project will also lay the scientific foundation for a planned future study to predict enrollment of patient populations traditionally underrepresented in clinical research in publicly funded cancer clinical trials.