COVID-19疫情爆发之前，妇科肿瘤临床试验中的远程医疗访诊和远程临床试验操作（如本地实验室测试或影像学研究）被少有使用。目前的文献对这些运营变化的描述主要是经验性的案例和专家意见，很少有研究描述患者安全数据。我们的目标是评估COVID-19疫情期间远程医疗和远程临床试验操作的安全性和可行性。我们在一个单一的学术机构中确定了在指定的远程医疗前和远程医疗期间参与临床试验并正在接受治疗的妇科肿瘤患者。纳入了至少有1次医疗提供者或研究协调员远程医疗访问的患者。收集了患者的人口统计学资料、健康系统接触情况、不良事件和试验协议偏差。采用了前后对比的方法，以每位患者作为自己的对照进行配对比较。符合纳入标准的患者有31例。远程医疗期间，虚拟医疗提供者的访问和非院内实验室检测增加了。提供者访问、影像学和实验室检测的延误在两个时间段之间没有显著差异。总体和轻微的试验协议偏差在远程医疗期间的发生率增加，原因是远程医疗的记录和非治疗性测试的推迟。重大的试验协议偏差、急诊就诊、住院和严重不良事件的发生率很低，并且在两个时间段之间没有显著差异。远程医疗和远程临床试验操作在这个小规模、单一机构的研究中似乎是安全的，并且不会损害临床试验协议。应进行更大范围的评估，以确定疫情后的持续实用性。版权所有 © 2023 Elsevier Inc.

Prior to the COVID-19 pandemic, telehealth visits and remote clinical trial operations (such as local collection of laboratory tests or imaging studies) were underutilized in gynecologic oncology clinical trials. Current literature on these operational changes provides anecdotal experience and expert opinion with few studies describing patient-level safety data. We aimed to evaluate the safety and feasibility of telehealth and remote clinical trial operations during the COVID-19 Pandemic.Gynecologic oncology patients enrolled and actively receiving treatment on a clinical trial at a single, academic institution during the designated pre-Telehealth and Telehealth periods were identified. Patients with at least 1 provider or research coordinator telehealth visit were included. Patient demographics, health system encounters, adverse events, and protocol deviations were collected. Pairwise comparisons were performed between the pre-Telehealth and Telehealth period with each patient serving as their own control.Thirty-one patients met inclusion criteria. Virtual provider visits and off-site laboratory testing increased during the Telehealth period. Delays in provider visits, imaging, and laboratory testing did not differ between time periods. Total and minor protocol deviations increased in incidence during the Telehealth period and were due to documentation of telehealth and deferment of non-therapeutic testing. Major protocol deviations, emergency department visits, admissions, and severe adverse events were of low incidence and did not differ between time periods.Telehealth and remote clinical trial operations appeared safe and did not compromise clinical trial protocols in a small, single institutional study. Larger scale evaluations of such trial adaptations should be performed to determine continued utility following the Pandemic.Copyright © 2023. Published by Elsevier Inc.