新型冠状病毒肺炎疫情下药物临床试验机构管理策略探讨

Management Strategy of Drug Clinical Trial Institutions During the Coronavirus Disease 2019 Epidemic

目的在做好新型冠状病毒肺炎疫情防控工作前提下,提升药物临床试验机构管理水平,加快药物研发进度。方法就疫情防控时期药物临床试验机构临床试验人员管理、项目管理和流程管理等方面展开探讨,为药物临床试验机构临床试验能力建设提升提供建议。结果与结论应在保障临床试验受试者、从业人员的健康安全基础上,完善临床试验组织管理规范及药物临床试验信息系统,并加强临床试验人员、试验项目及试验流程的管理,让临床试验项目有序开展且高效、高质量完成。

Objective To improve the management level of drug clinical trial institutions and accelerate the progress of drug research and development under the premise of doing well in the prevention and control of coronavirus disease 2019(COVID-19)epidemic.Methods The management of clinical trial staff,project and process in drug clinical trial institutions during the period of epidemic prevention and control was investigated to provide suggestions for the improvement of the clinical trial capacity of drug clinical trial institutions.Results and Conclusion On the basis of ensuring the health and safety of clinical trial subjects and practitioners,we should improve the management standard of clinical trial organization and the system of drug clinical trial information,and strengthen the management of clinical trial staff,project and process,in order to orderly and efficiently carry out the clinical trial project with high quality.