Trend in Clinical Trial Participation During COVID-19: A Secondary Analysis of the I-SPY COVID Clinical Trial.
Trend in Clinical Trial Participation During COVID-19: A Secondary Analysis of the I-SPY COVID Clinical Trial.
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DOI：
10.1097/cce.0000000000000930
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发表时间：
2023-06
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分析美国前三波大流行期间COVID-19平台试验入学率的时间趋势。I-SPY COVID随机对照试验（RCT）数据的二次分析。全美有31家医院。直接或通过合法授权代表接触患者，征求其同意并纳入I-SPY COVID RCT。没有。在2020年7月30日至2022年2月17日进行的I-SPY COVID试验的1338名患者中，使用入组患者（n = 1063）与减少参与（n = 275）的数量来计算每月入组率。总体而言，入组组和退组组的人口学和基线临床特征相似。在COVID-19大流行期间，入学率有所波动，但没有随时间变化的显著趋势（Mann-Kendall检验，p = 0.21）。接种疫苗和未接种疫苗的患者的入学率也具有可比性。在多变量logistic回归分析中，年龄、性别、居住地区、COVID-19疾病严重程度和疫苗接种状况与拒绝同意的决定无显著相关。在这项对I-SPY COVID临床试验的二级分析中，在所有符合临床试验参与条件的患者中，入组率与时间或疫苗接种状况之间没有显着关联。需要进一步的研究来更好地了解COVID-19大流行是否改变了临床试验的参与情况，并制定鼓励参与未来COVID-19和重症监护临床试验的战略。
To analyze the temporal trend in enrollment rates in a COVID-19 platform trial during the first three waves of the pandemic in the United States. Secondary analysis of data from the I-SPY COVID randomized controlled trial (RCT). Thirty-one hospitals throughout the United States. Patients who were approached, either directly or via a legally authorized representative, for consent and enrollment into the I-SPY COVID RCT. None. Among 1,338 patients approached for the I-SPY COVID trial from July 30, 2020, to February 17, 2022, the number of patients who enrolled (n = 1,063) versus declined participation (n = 275) was used to calculate monthly enrollment rates. Overall, demographic and baseline clinical characteristics were similar between those who enrolled versus declined. Enrollment rates fluctuated over the course of the COVID-19 pandemic, but there were no significant trends over time (Mann-Kendall test, p = 0.21). Enrollment rates were also comparable between vaccinated and unvaccinated patients. In multivariable logistic regression analysis, age, sex, region of residence, COVID-19 severity of illness, and vaccination status were not significantly associated with the decision to decline consent. In this secondary analysis of the I-SPY COVID clinical trial, there was no significant association between the enrollment rate and time period or vaccination status among all eligible patients approached for clinical trial participation. Additional studies are needed to better understand whether the COVID-19 pandemic has altered clinical trial participation and to develop strategies for encouraging participation in future COVID-19 and critical care clinical trials.