Abstract
Since the end of 2019, the spread of the corona virus disease 2019 (COVID-19) has caused serious economic shocks and social impacts. The development of clinical trials of drugs has also brought many difficulties and challenges. Based on the particularity of the population and process of the Phase I clinical trials of the drug, it caused us to think about the management of the subjects in the Phase I clinical trials under the influence of the COVID-19. It proposes various strategies from the different stages of subject recruitment, screening, and admission, to subject education, diet management, and observation of adverse events. It aims to discuss how to protect the safety and rights of subjects better under the normalization of epidemic prevention and control, strengthen the risk control of clinical trials, and ensure the successful completion of trials.
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