艰难与困苦：外科临床试验研究者的职业发展。
Trials and tribulations: the professional development of surgical trialists.
机构信息
Department of Surgery, The Methodist Hospital, Houston, TX, USA.
出版信息
Am J Surg. 2012 Sep;204(3):339-346.e5. doi: 10.1016/j.amjsurg.2011.11.008.
BACKGROUND
Regulatory and professional bodies issue an ever-increasing number of guidance documents on the ethics and methods of clinical trials, but the quality of clinical trials of invasive therapeutic procedures continues to be a concern. We interviewed aspiring and accomplished surgical trialists to understand how they use guidance documents and other resources in their work.
METHODS
We performed a qualitative research study involving semistructured interviews of a diverse sample of 15 surgical trialists.
RESULTS
Professional development as a surgical trialist was haphazard, inefficient, and marked by avoidable mistakes. Four types of resources played constructive roles: formal education; written materials on clinical trials; experience with actual trials; and interpersonal interactions with peers, experts, collaborators, and mentors. Recommendations for improvement centered on education, mentoring, networking, participating in trials, and facilitation by department chairs.
CONCLUSIONS
The haphazard and unstructured nature of the current system is adding unnecessarily to the numerous challenges faced by surgical trialists.
背景
监管和专业机构发布了越来越多关于临床试验伦理和方法的指导文件，但侵入性治疗程序临床试验的质量仍然令人担忧。我们采访了有抱负和有成就的外科试验研究者，以了解他们在工作中如何使用指导文件和其他资源。
方法
我们进行了一项定性研究，对 15 名不同的外科试验研究者进行了半结构化访谈。
结果
作为外科试验研究者的专业发展是偶然的、低效的，并且存在许多可以避免的错误。有四类资源发挥了建设性作用：正规教育；临床试验方面的书面材料；实际试验经验；以及与同行、专家、合作者和导师的人际互动。改进的建议集中在教育、指导、网络、参与试验以及系主任的协助。
结论
当前系统的随意性和非结构化性质给外科试验研究者带来了许多不必要的挑战。
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