Ⅰ期药物临床试验健康受试者参与体验的质性研究

Qualitative study on the experience of healthy subjects participating the phase Ⅰ drug clinical trials

目的:了解Ⅰ期药物临床试验健康受试者参与试验的体验,为促进国内Ⅰ期药物临床试验受试者参与试验的有效开展提供理论依据。方法:采用质性研究法,对符合纳入标准的12例Ⅰ期药物临床试验健康受试者参与试验的体验进行半结构化访谈,采用Colaizzi分析法进行资料分析、总结、归纳。结果:提炼出Ⅰ期药物临床试验健康受试者参与试验体验感受的5个主题:责任与使命感、惧怕与信任并存、缺乏全面信息来源、认可与羞愧矛盾、爱与尊重的需要。结论:需重视Ⅰ期临床研究受试者的感受,采取相关措施,加强相关知识的宣传、扩宽宣传群体,加强有效沟通,充分发挥护理的优势,提高受试者的依从性。

Objective: To understand the experience of healthy subjects participating phase Ⅰ drug clinical trials, in order to provide a theoretical basis for the effective development of domestic phase Ⅰ drug clinical trials in which subjects participate. Methods: A qualitative research method was used to conduct semi-structured interviews on the experience of 12 healthy subjects who met the inclusion criteria in phase Ⅰ drug clinical trials. The data were analyzed and summarized using Colaizzi analysis. Results: Five themes regarding the participating experience of healthy subjects in phase Ⅰ drug clinical trials were refined, including responsibility and mission, fear and trust coexist, lack of comprehensive information sources, recognition and shame conflicts, and the requirement for love and respect. Conclusion: It is necessary to take care of the feelings of the subjects in the phase Ⅰ clinical study, take relevant measures to strengthen the publicity of related knowledge, broaden the publicity group, strengthen effective communication, give full play to the advantages of nursing, and improve the compliance of the subjects.