Investigation and analysis of the impact of severe acute respiratory syndrome coronavirus 2 outbreak on the development of GCP

ABSTRACT

Objective: In order to understand the current status of the work of clinical-trial-related units, strengthen communication between units, analyze relevant impact factors, and predict development trends of good clinical practice (GCP) field in the future based on the severe epidemic situation. Methods: Combined with key work in the GCP field, a questionnaire was compiled to widely understand the value of clinical trial staffs in response to outbreaks, the status of clinical trials, and their outlook for development. Statistical analysis performed after feedback was collected. Results: A total of 357 valid questionnaires were recovered. 53.45% of clinical trial institutions released response rules within 3 days, and only 5.17% of clinical trial institutions have not released relevant response measures so far. E-mail acceptance methods of research institutions accounted for 52.02%, suspended reviews of ethics committees accounted for 50.62%, and online conference reviews accounted for 22.36%. The main methods of follow-up of the subjects: telephone follow-up 35.16%, delayed follow-up 21.8%, off-site follow-up 16.03%. Off-site subjects who cannot come to the hospital and need to send medicine accounted for 50.62% and delayed drug administration for 28.88%. Different sponsors, contract research organization (CRO), site management organization (SMO) companies have taken proactive measures, such as formulating detailed drug delivery processes based on project characteristics, and remote monitoring by clinical research associate (CRA). 86.27% of employees still have great confidence in the future development of the GCP field. Conclusion: The epidemic has affected the current work of the GCP industry to varying degrees, but most units have adopted active and effective measures to maximize the health and safety of participants in clinical trials, and they still have strong confidence in the work status and development of units in GCP field after the epidemic.