Rychlíčková Jitka, Čechová Zora, Nagy Viktoria, Nebeská Kateřina, Součková Lenka, Mouly Stéphane, Kovacs Gabor Laszlo, Kubiak Christine, Takács Eva, Moreira de Oliveira Tiago H, Painho Marco, Monteiro Emília C, Maia Sara, Batuca Joana, Shiely Frances
Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
Centre of Excellence, CREATIC at Masaryk University, Brno, Czech Republic.
BMC Med Educ. 2025 Apr 8;25(1):502. doi: 10.1186/s12909-025-07054-5.
Investigator-initiated trials (IITs) bridge the gap between applied clinical research and everyday clinical practice. However, they require the skilled multidisciplinary teams from different backgrounds but all with clinical trial training to ensure trials are designed, conducted and reported according to best practice and regulatory standards. The availability of trainings to fulfil these needs is limited. The CONSCIOUS II project facilitated to expand the supply of such programmes. The objective is to describe the curriculum designed for PhD students and early-career researchers, and evaluate participants' perceptions and feedback after completion of the training.
The curriculum was developed according to key principles that underpin building of competencies relevant to quality IITs and transdisciplinary skills. A multidisciplinary team created the curriculum, elaborated a comprehensive set of study materials, including the training platform. This team also conducted an international, collaborative pilot course. The effectiveness of the educational materials for the target audience was assessed through questionnaires administered after the pilot course. Additionally, all learning materials, including the video recordings of the pilot course, were externally evaluated.
A 12-chapter thoroughly revised curriculum was developed for asynchronous preparation and served as a pre-class reading for a 3-month pilot course. The chapters, along with supplementary materials, and recordings of the pilot course are freely accessible on the CONSCIOUS II training platform. This platform facilitates the dissemination and implementation in the existing curricula. The feedback from both the pilot course participants and the stakeholders was uniformly positive across all survey aspects.
This remote programme which combines asynchronous and synchronous components with international and interprofessional collaboration effectively addresses the gap in developing core competencies for the 21st -century clinical researchers. The implementation of this curriculum has the potential to improve the quality of IITs.
研究者发起的试验（IITs）填补了应用临床研究与日常临床实践之间的差距。然而，它们需要来自不同背景但都接受过临床试验培训的多学科专业团队，以确保试验按照最佳实践和监管标准进行设计、实施和报告。满足这些需求的培训资源有限。CONSCIOUS II项目有助于扩大此类项目的供应。其目标是描述为博士生和早期职业研究人员设计的课程，并评估培训结束后参与者的看法和反馈。
该课程是根据与高质量IIT相关的能力建设和跨学科技能的关键原则开发的。一个多学科团队创建了课程，精心编写了一套全面的学习材料，包括培训平台。该团队还开展了一个国际合作试点课程。通过试点课程结束后发放的问卷评估了教育材料对目标受众的有效性。此外，所有学习材料，包括试点课程的录像，都进行了外部评估。
开发了一个包含12章的经过全面修订的课程，用于异步预习，并作为为期3个月的试点课程的课前阅读材料。这些章节以及补充材料和试点课程的录像可在CONSCIOUS II培训平台上免费获取。该平台有助于在现有课程中进行传播和实施。试点课程参与者和利益相关者的反馈在所有调查方面都一致积极。
这个远程项目将异步和同步组件与国际和跨专业合作相结合，有效地弥补了为21世纪临床研究人员培养核心能力方面的差距。该课程的实施有可能提高IITs的质量。
