Enhancing pragmatic competence in investigator-initiated clinical trials

Introduction 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. Methods 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. Results 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. Conclusion 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.

Descrição

Rychlíčková, J., Čechová, Z., Nagy, V., Nebeská, K., Součková, L., Mouly, S., Kovacs, G. L., Kubiak, C., Takács, E., Moreira de Oliveira, T. H., Painho, M., Monteiro, E. C., Maia, S., Batuca, J., & Shiely, F. (2025). Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme. BMC Medical Education, 25, 1-7. Article 502. https://doi.org/10.1186/s12909-025-07054-5 --- Supported by the national budget through MEYS, LRI CZECRIN (LM2023049) and ERASMUS+ (project CONSCIOUS II, 2021-1-CZ01-KA220-HED-000023177).

Palavras-chave

Investigator-initiated trials Curriculum Early-career researchers Practice-oriented Education

URI

http://hdl.handle.net/10362/182283

DOI

10.1186/s12909-025-07054-5

Coleções

NIMS: MagIC - Artigos em revista internacional com arbitragem científica (Peer-Review articles in international journals)

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