Conduct of clinical trials under primary response to major public health emergencies in tertiary hospital / 中华医学科研管理杂志

ABSTRACT

Objective:Understand the status of clinical trials under primary response to major public health emergencies (COVID-19 epidemic) in tertiary hospital.Methods:The electronic questionnaire was used to collect information of clinical trials, including these have been approved by ethical committee, still in the recruiting process or in the following up of enrolled human subject. The questionnaire included basic information, measures adopted by the trials and experiences for dealing with the common problems associated conducting clinical trials during the pandemic.Results:A total of 198 questionnaires were returned, including 92 trials that have not yet recruited subjects and 106 trails that have recruited subjects. 59.15% of clinical trials that haven’t been initiated decide to postpone the starting date and 76.19% of clinical trials that haven’t recruited subjects decided to postpone subject recruitment. 36.87% of clinical trials made contingency plan or other similar documents. For those trials that have started to recruit subjects, 5.66% clinical trials prolonged follow-up time window, 61.32% of clinical trials followed up subjects and 51.89% of clinical trials provided instructions to subjects through remote technology, 51.89% of clinical trials allowed subjects to do lab tests in nearby hospitals. 38.68% clinical trials mailed drugs to subjects under guaranteed transportation conditions. For clinical trials that required subjects come to hospital to follow up, 92% of clinical trials will check whether subjects had been to high risk area and measure body temperature when follow-up. For clinical trials involving delayed follow-up, 46.97% of clinical trials would recorded and reported protocol deviation, 6.07% of clinical trials would not report or have not yet decided whether to report protocol deviation.Conclusions:Sponsors and hospitals conducting clinical trials abide by the basic principles of epidemic prevention and take corresponding measures according to local conducting, focusing on the protection of subjects. Most clinical trials comply with the Good Clinical Practice and ethical principles to ensure that clinical trial were carried out as effectively as possible.