Medicine

Investigation and research on the state of clinical trials during epidemic period of COVID-19

X. Zhu, J. Dai, L. Liu, J. Zhu, M. Lu, L. Wang, Q. Zhu, Jing Wang

2021Chinese Journal of New Drugs

tlooto Summary

It is a new working mode for clinical trial institutions to improve the emergency mechanism of clinical trials, strengthen the supervision of trials, and realize the sharing of clinical trial data and the whole process information management.

Abstract

With coronavirus disease 2019 (COVID-19) spreading, the rhythm of clinical trials has been challenged Based on the guidelines and relevant regulations of clinical trials during the epidemic period, the Drum Tower Hospital Affiliated to Nanjing University School of medicine has designed a survey to investigate the current situation of clinical trials Association, CRA, clinical research coordinator (CRC), and test managers were involved in the research According to the survey results, most researchers reflected that the progress of clinical trials was affected (68 24%), and the clinical trials of non-oral drugs were greatly affected (69 96%), which was mainly manifested in the malignant tumor project (88 2%), during the trial, the most obvious influence is 92 7% for out of visit window, and the subject worrying about the deterioration of disease (78 97%), the risk of drug overtemperature exists in mailing drugs (60 09%), and the number of trials timeliness (89 09%) and integrity (79 61%) were the most affected Therefore, it is a new working mode for our clinical trial institutions to improve the emergency mechanism of clinical trials, strengthen the supervision of trials, and realize the sharing of clinical trial data and the whole process information management © 2021, Chinese Journal of New Drugs Co Ltd All right reserved

Citation format

ZHU, X., et al. Investigation and research on the state of clinical trials during epidemic period of COVID-19. Chinese Journal of New Drugs, 2021, 30: 50–54.