Key points of serious adverse event and protection of patients in ophthalmic clinical trials during novel coronavirus pneumonia outbreak

Authors: Zhang Peng,  Lu Yingyi,  Song Shuang,  Yu Xiaobing,  Dai Hong

DOI: 10.3760/cma.j.cn115989-20200217-00072
Published 2020-03-10
Cite as Chin J Exp Ophthalmol, 2020,38(03): 273-275.

Abstract

The prevention and control of novel coronavirus pneumonia is the most priority recently, and various measures during the prevention and control period will have varying degrees of impact on the implement of clinical trials.However, various examinations in ophthalmological clinical trials need close contact between operators and patients, which put us at risk of cross-infection.This paper indicated some suggestions based on the criteria of clinical trials under major public health emergencies, the management of clinical trials during epidemic period, including the follow-up of subjects, the treatment of epidemic serious adverse event (SAE) and the management requirements of co-sponsors, as well as the requirements and management principles for environment, subjects, examiners and inspection equipment in the process of ophthalmic clinical trials.It may be helpful to the ophthalmic clinical trial researchers and subjects during the period of novel coronavirus infection.

Key words:

Novel coronavirus; Clinical trials; Follow-up management; Ophthalmology

Contributor Information

Zhang Peng
Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Insitute of Geriatric Medicine, Chinese Academy of Medical Science, Beijing 100730, China
Lu Yingyi
Song Shuang
Yu Xiaobing
Dai Hong
(Read 73 times, 1 visits today)
Updated: June 24, 2020 — 11:28 am