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

癌症临床试验可获得性差异的多水平分析 少数群体参与癌症临床试验对于确保可推广性至关重要 产生的结果，促进了新疗法的发现和治疗反应 尤其与传统上代表人数不足的人群有关，并确保公平获得 为新的有希望的治疗方法干杯。然而，在国会下令 美国国立卫生研究院确保少数族裔充分和适当地参与临床研究， 许多少数民族人口的参与率仍然大大低于其构成 占美国总人口的比例。获得癌症临床试验机会的差距是阻碍 减少参与审判的差距。因此，理解地理位置的作用是至关重要的 变异在推动获得癌症临床试验方面的差异方面发挥了作用，如果我们要设计和 以有效干预措施为目标，改善少数群体参与这类试验的情况。先前的研究已经 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 影响少数民族不同类型癌症临床试验可得性的因素 人口减少有两个主要原因。首先，我们目前缺乏一个全面的数据库 关于试验地点的足够详细的试验级别特征或信息 推出的原因是很难从多个来源使用 传统的记录链接方法。因此，先前的研究评估了可获得性的差异 的癌症临床试验在检查的因素范围内受到了重要的限制，而 研究的试验数量和类型。其次，癌症临床试验往往是在多个阶段启动的 在较大的医疗保健系统内运行的网站，以及个人招聘网站通常 参与多项试验，这对理清 不同试验、现场和医疗保健系统水平的因素与癌症临床的关系 试用版。我们建议通过整合来自以下领域的信息来应对这些挑战 使用高级记录链接方法和应用复杂建模的多个来源 分析所产生的多级别数据的技术。拟议的研究将会有所改善 了解癌症临床试验的可获得性在不同地理环境中的差异 和临床试验组合，这可能有助于有针对性的干预和政策，以解决 在进入最需要帮助的地区方面存在差距。该项目也将为科学的 为计划中的未来研究奠定基础，以预测传统上的患者群体登记人数 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.