Saleh Mansoor, Naik Gurudatta, Jester Penelope, Joiner Cynthia, Westfall Elizabeth, Kimberlin David W, Willig James, Redden David, Southworth Juliette, Dransfield Mark T
University of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, United States.
University of Alabama at Birmingham, Department of Pediatrics, Division of Pediatric Infectious Diseases, United States.
Contemp Clin Trials Commun. 2020 Jun 12;19:100589. doi: 10.1016/j.conctc.2020.100589. eCollection 2020 Sep.
Clinical investigation is a critical component of clinical medicine. Yet, other than mentorship by an experienced senior physician, young physicians have few formal training opportunities that fit into their clinical training and convey the pre-requisite clinical investigator competencies. To address this training gap, we designed the Clinical Investigator Training Program (CITP); a practical and pragmatic curriculum weaved into the constant pressures of balancing patient care with academic pursuit required of the academic practitioner.
Between January 2016 and December 2018, we conducted four CITP courses, with each comprised of four 4-h sessions that included didactic lectures, group projects including the development of a mock clinical protocol, and expert's panel discussions. Each course enrolled 15 participants from an average of 28 applicants. We assessed the knowledge acquired following each course via a pre- and post-course test (-test with positive scores indicating improvement in knowledge base). In addition, we also tracked which participants became first time principal investigator following completion of CITP.
A total of 60 participants enrolled in the 4 CITP courses, and there was a statistically significant improvement in mean post-test scores (p < 0.01). The number of participants achieving first time principal investigator status nearly doubled following CITP from 17 to 33. Conversely, applicants not selected for CITP demonstrated no similar improvement during the same follow up period.
The improvement in test scores and the substantive uptake in first time principal investigator responsibilities following CITP affirms that CITP provides a viable option to convey investigator competencies and encourage clinicians to take on the role of principal investigators.
临床研究是临床医学的关键组成部分。然而，除了经验丰富的资深医师的指导外，年轻医师几乎没有适合其临床培训且能传授临床研究者必备能力的正规培训机会。为填补这一培训空白，我们设计了临床研究者培训项目（CITP）；这是一门实用且务实的课程，融入了学术从业者在平衡患者护理与学术追求的持续压力之中。
在2016年1月至2018年12月期间，我们开展了四门CITP课程，每门课程由四个4小时的环节组成，包括理论讲座、小组项目（包括制定模拟临床方案）以及专家小组讨论。每门课程平均从28名申请者中招收15名参与者。我们通过课程前后测试评估每门课程后所获得的知识（测试得分呈正值表明知识库有所提升）。此外，我们还追踪了哪些参与者在完成CITP后首次成为主要研究者。
共有60名参与者参加了这四门CITP课程，测试后平均得分有统计学显著提高（p < 0.01）。完成CITP后，首次获得主要研究者身份的参与者数量几乎翻倍，从17人增至33人。相反，未被选入CITP的申请者在同一随访期内未表现出类似的进步。
CITP后测试成绩的提高以及首次承担主要研究者职责的实质性增加，证实了CITP为传授研究者能力和鼓励临床医生承担主要研究者角色提供了一个可行的选择。
