Study on the Protection of the Rights and Interests of Tumor Subjects in Clinical Trials in the Prevention and Control of the COVID -19
10.12026/j.issn.1001-8565.2022.05.07
- VernacularTitle:新冠肺炎疫情防控背景下肿瘤临床试验受试者权益保护探究
- Author:
Zhiqing DAI
1
;
Mei YIN
1
Author Information
1. College of Humanities and Social Sciences, Harbin Medical University, Harbin 150081, China
- Publication Type:Journal Article
- Keywords:
COVID -19;
Epidemic Prevention and Control;
Tumor;
Clinical Trial;
Subject Protection
- From:
Chinese Medical Ethics
2022;35(5):503-507
- CountryChina
- Language:Chinese
-
Abstract:
The outbreak of the COVID -19 has had a big impact on the implementation of clinical trials of tumor drugs and the prevention and control measures such as traffic control and home isolation has caused clinical trials couldn’t proceed normally, so the protection of tumor subjects in clinical trials faces many new challenges. Based on Western and Chinese policies and guidelines on the management of clinical trials during the COVID -19, this paper expounded the impacts of the COVID -19 on tumor patients and tumor clinical trials, analyzed the challenges faced by the protection of tumor subjects in the prevention and control of the COVID -19, and then protected tumor subjects from aspects of optimizing the allocation of health resources, improving non-face-to-face informed consent procedures, strengthening subject visit management, and enhancing clinical trial safety evaluation. It is hoped that these optimization measures can face the future and continue to protect subjects after the end of the epidemic or in new public health emergencies.
