Greenberg-Worisek Alexandra J, Cornelius Katherine E, Cumba Garcia Luz, Enders Felicity T, Shah Nilay D, Windebank Anthony J
Center for Clinical and Translational Science, Mayo Clinic, Rochester, MN, USA.
Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
J Clin Transl Sci. 2019 Dec 23;4(1):8-15. doi: 10.1017/cts.2019.432. eCollection 2020 Feb.
As the pace of biomedical innovation rapidly evolves, there is a need to train researchers to understand regulatory science challenges associated with clinical translation. We describe a pilot course aimed at addressing this need delivered jointly through the Mayo Clinic Center for Clinical and Translational Science and the Yale-Mayo Center for Excellence in Regulatory Science and Innovation. Course design was informed by the Association for Clinical and Translational Science's Regulatory Science Working Group's competencies. The course used didactic, case-, and problem-based learning sessions to expose students to regulatory science concepts. Course evaluation focused on student satisfaction and learning. A total of 25 students enrolled in the first two course deliveries. Students represented several disciplines and career stages, from predoctoral to faculty. Students reported learning "an incredible amount" (7/19, 36.8%) or "a lot" (9/19, 47.4%); this was reflected in individual coursework and their course evaluations. Qualitative feedback indicated that assignments that challenged them to apply the content to their own research were appreciated. The heterogeneity of students enrolled, coupled with assessments and course evaluations, supports the statement that there is a growing need and desire for regulatory science-focused curricula. Future research will determine the long-term impact.
随着生物医学创新步伐的迅速发展，有必要培养研究人员了解与临床转化相关的监管科学挑战。我们描述了一门试点课程，旨在满足这一需求，该课程由梅奥诊所临床与转化科学中心以及耶鲁 - 梅奥监管科学与创新卓越中心联合提供。课程设计参考了临床与转化科学协会监管科学工作组的能力要求。该课程采用讲授、案例和基于问题的学习环节，让学生接触监管科学概念。课程评估侧重于学生满意度和学习情况。前两期课程共有25名学生报名。学生代表了多个学科和职业阶段，从博士前到教师。学生报告称学到了“大量”（7/19，36.8%）或“很多”（9/19，47.4%）的知识；这在个人课程作业和课程评估中都有所体现。定性反馈表明，那些促使他们将所学内容应用到自己研究中的作业受到好评。所招收学生的多样性，再加上评估和课程评价，支持了这样一种说法，即对以监管科学为重点的课程的需求和渴望在不断增长。未来的研究将确定其长期影响。
