| Phase I clinical trial of drugs is a preliminary clinical pharmacology and human safety evaluation test.To observe the tolerance and pharmacokinetics of new drugs in human body,and to provide basis for formulating drug delivery plan.As the experimental drug is first used in human body,its clinical trial program is based only on the pharmacological and toxicological data of preclinical animal studies.In addition to the known side effects,there is also a great possibility of unpredictable risks.For this reason,Phase I trials are often the most difficult stage for subjects to recruit in the course of drug clinical trials.To understand the cognitive status of healthy subjects and the influencing factors of their attitudes toward Phase I trials,and to improve the recruitment process of healthy subjects in Phase I trials,so as to promote the healthy development of Phase I trials.In this study,qualitative and quantitative analysis,questionnaires and semi-structured interviews were used to explore the cognitive status of medical students in Shanxi Province about phase I clinical trials of drugs and the influencing factors of their attitudes to phase I trials.The participants were students of medical colleges in Shanxi Province.2223 valid questionnaires were collected.Eight interviewees were included in the interview.Three of them had experience in phase I clinical trials of drugs,and five of them had no experience in phase I clinical trials of drugs.The first part of the research data is a questionnaire survey of medical college students in Shanxi Province.SPSS18.0 software is used to input,organize and analyze.Statistical analysis methods include descriptive statistics and chi-square test.The second part is an interview with some healthy subjects of medical students.Audio data are manually converted into text data for research and analysis.The study concluded that the overall awareness rate of Phase I test was higher among medical students,and they had a better understanding of the basic links and significance of Phase I test.However,little is known about the functions and roles of ethics committees.At the same time,in the rights of subjects,the right to voluntary participation andwithdrawal is misunderstood.And the cognitive level of potential subjects in urban areas is higher than that in rural areas.In addition,it is noteworthy that healthy subjects who have participated in phase I trials tend to "desensitize" their risk perception of phase I trials,and their ability to assess risks gradually declines,even ignoring the risks in the process of participating in phase I trials.The study concluded that although medical students generally have a better understanding of Phase I trials,their overall willingness to participate is low.There are many influencing factors for potential participants to participate in Phase I trials,including drug safety factors,Altruistic factors,economic factors,family factors,factors of trust in doctors,factors of experience in clinical trials,relevant factors of research institutions,etc.The side effects and safety related factors of the experimental drugs are the primary factors considered by potential subjects.Altruistic behavior,volunteer spirit and economic factors also have an important impact on subjects’ decision-making.In addition,family factors should also play a full role in recruiting subjects.According to the conclusions of the study,some suggestions are put forward from the aspects of education,recruitment and society of the personnel involved in the phase I clinical trial of drugs: strengthening risk awareness education for healthy subjects and researchers;paying attention to the function of family factors in the recruitment of healthy subjects;perfecting the compensation measures in China by drawing lessons from the compensation system in the Japanese clinical trial of drugs and introducing more perfect drugs.The laws and regulations of Phase I clinical trial should be established to protect the safety and rights of healthy subjects fundamentally. |
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