Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York, USA.
Department of Biomedical Informatics, Columbia University, New York, New York, USA.
J Am Med Inform Assoc. 2021 Oct 12;28(11):2461-2466. doi: 10.1093/jamia/ocab167.
Hundreds of interventional clinical trials have been launched in the United States to identify effective treatment strategies for combating the coronavirus disease 2019 (COVID-19) pandemic. However, to date, only a small fraction of these trials have completed enrollment, delaying the scientific investigation of COVID-19 and its treatment options. This study presents novel metrics to examine the geographic alignment between COVID-19 hotspots and interventional clinical trial sites and evaluate trial access over time during the evolving pandemic. Using temporal COVID-19 case data from USAFacts.org and trial data from ClinicalTrials.gov, U.S. counties were categorized based on their numbers of cases and trials. Our analysis suggests that alignment and access have worsened as the pandemic shifted over time. We recommend strategies and metrics to evaluate the alignment between cases and trials. Future studies are warranted to investigate the impact of the misalignment of cases and clinical trial sites on clinical trial recruitment.
美国已经启动了数百项介入性临床试验,以确定抗击 2019 年冠状病毒病(COVID-19)大流行的有效治疗策略。然而,迄今为止,这些试验中只有一小部分完成了入组,这延迟了对 COVID-19 及其治疗选择的科学研究。本研究提出了新的指标来检查 COVID-19 热点地区与介入性临床试验地点之间的地理一致性,并评估在不断演变的大流行期间随时间推移的试验可及性。使用来自 USAFacts.org 的时间性 COVID-19 病例数据和来自 ClinicalTrials.gov 的试验数据,根据病例和试验数量对美国各县进行了分类。我们的分析表明,随着时间的推移,这种一致性和可及性已经恶化。我们建议评估病例和试验之间一致性的策略和指标。未来的研究有必要调查病例和临床试验地点的不匹配对临床试验招募的影响。