ABSTRACT
AIM: Describe the general situation of the First-In-Human trials of the drugs, and summarize the design and results of the First-In-Human trials. METHODS: We searched the literature of the First-In-Human trials in 2009-2020 on PubMed and screened out the literature that met the research purpose. The basic information of the literature was collected. Data analysis was conducted to summarize relevant outcomes. RESULTS: A total of 559 First-In-Human trials were included in this study. The types of drugs included small molecule drugs (52.42%, 293/559), macromolecule drugs (45.62%, 255/559), and a small amount of cells and viruses (1.97%, 11/559) and so on. Regarding the determination of the starting dose, whether it was in macromolecules (23.86%, 21/88) or small molecules (30.15%, 41/136), No Observed Adverse Effect Level (27.68%, 62/224) was mainly used as the main reference basis, followed by preclinical research (21.88%, 49/224) and Minimal Anticipated Biological Effect Level (8.48%, 19/224), etc. In the dose escalation test, 50.19%(135/269) of the studies used the traditional standard 3+3 dose escalation method, followed by the accelerated titration method (7.06%, 19/269), and the improved 3+3 method (6.69%, 18/269), etc. CONCLUSION: The design of First-In-Human clinical trials has certain regularity in the content and results of the research design. In the subsequent trials, it is important to scientifically design the First-In-Human trials, and promote the safe and effective development of the First-In-Human trials of the drugs.
ABSTRACT
Interest temptation is a relatively hidden improper activity in medical human trials.Improper influence brought by interest temptation mainly displays allure in mind on subjects,which may lead them to make unreal promise.To avoid interest temptation and the undue influence,it needs to essentially distinguish interest temptation and interest sharing,apply different rules to different types of the subjects and strengthen the supervision function of institutional ethics committee.
ABSTRACT
Human trials are necessary to medical development,but the experiments need to be reviewed under the condition of informed consent.The current ethical review of informed consent in China exist some limits.For example,the corresponding normative legal status is low,the tracing review of informed consent becomes a mere formality,and the ethical review mechanism is not perfect,and so on.We should strengthen the examination of the ethical examination of human trials,increase the tracking and examination of informed consent of human trials,and improve the supporting mechanism of ethical review,and thus to safeguard the life and health rights and interests and personality dignity.