Common problems and strategies of healthy subjects management in early drug clinical trials
Early drug clinical trials often focus on healthy subjects,with different motivations from patients to participate in the trial,healthy subjects often aim to quickly obtain compensation,and their age and background are significantly different from the patient population.Therefore,there are significant differences in the management of healthy subjects and patients during the trial period.This research takes the entire process of healthy subjects participating in early drug clinical trials as the main thread,listing the real problems found in various stages such as screening,hospitalization,and discharge.Combin-ing with the published papers in journals in this field and author's actual work experience,this article analyzes and explores the specific causes and response methods,providing reference for the full process management of healthy subjects in early drug clinical trials,to better comply with the quality management standards of drug clinical trials,safeguard the rights and safety of subjects,ensure the scientific and truthful nature of data and results,and promote the smooth progress of trials.
Clinical trials of drugsHealthy subjectsManagementDiscuss
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