Ethical Challenges in Novel Coronavirus Pneumonia Vaccine as Well as New Drug Research and Development

ABSTRACT

To review systematically the progress of all domestic and foreign clinical trials since the emergence of the COVID-19 epidemic and the overview of human challenge study (HCS) in the past year, grasp relevant information of ethical review, and explores the feasibility of human challenge study and provide references for stake holders. Based on the Chinese Clinical Trial Registration Center and clinical trial. gov, clinical trials that were consistent with COVID-19 was searched, and the deadline was June 11, 2020.Basic information was extracted and the number of trials was selected from the research type, clinical stage, recruitment status, and ethical passing status. Literature search was conducted based on Pubmed between January 1, 2019 and June 11, 2020.According to the included literature, basic information was extracted and opinions were reported on HCS. 638 and 1935 clinical trials were carried out at home and abroad respectively, of which the number of clinical trials carried out in Hubei reached 323. China and the United States conducted more interventional trials, and the United States had the most clinical trials entered in Phase II, there were a total of 142. Most of the clinical trials were in the stage of recruiting research subjects. In addition, a total of 539 clinical trials in China had passed ethical approval. A total of 5 documents were included in the Human Challenge Study, four maintained a positive attitude towards HCS and put forward corresponding thinking about ethical review. Under the COVID-19, clinical trials for new drugs and new coronavirus vaccines have rapidly increased, which puts forward higher requirements for the progress of ethical review. In the face of such public health emergencies and special research, it is urgent to establish a sound ethical review system and an ethical review system, as well as to construct an ethical model for special research. © 2021, Editorial Board of Pharmaceutical Biotechnology. All right reserved.