Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme

Simple item page
dc.contributor.authorRychlíčková, Jitkaen
dc.contributor.authorČechová, Zoraen
dc.contributor.authorNagy, Viktoriaen
dc.contributor.authorNebeská, Kateřinaen
dc.contributor.authorSoučková, Lenkaen
dc.contributor.authorMouly, Stéphaneen
dc.contributor.authorKovacs, Gabor Laszloen
dc.contributor.authorKubiak, Christineen
dc.contributor.authorTakács, Evaen
dc.contributor.authorMoreira de Oliveira, Tiago H.en
dc.contributor.authorPainho, Marcoen
dc.contributor.authorMonteiro, Emília C.en
dc.contributor.authorMaia, Saraen
dc.contributor.authorBatuca, Joanaen
dc.contributor.authorShiely, Francesen
dc.contributor.funderERASMUS+en
dc.date.accessioned2025-04-24T15:49:57Z
dc.date.available2025-04-24T15:49:57Z
dc.date.issued2025en
dc.description.abstractIntroduction: 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.en
dc.description.sponsorshipMEYS, LRI CZECRIN (LM2023049) and ERASMUS+ (project CONSCIOUS II, 2021-1-CZ01-KA220-HED-000023177)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid502en
dc.identifier.citationRychlíčková, J., Čechová, Z., Nagy, V., Nebeská, K., Součková, L., Mouly, S., Kovacs, G.L., Kubiak, C., Takács, E., Moreira de Oliveira, T. H. and Painho, M. (2025) 'Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme', BMC Medical Education, 25(1), p.502. DOI: 10.1186/s12909-025-07054-5en
dc.identifier.doi10.1186/s12909-025-07054-5en
dc.identifier.issn14726920en
dc.identifier.issued1
dc.identifier.journaltitleBMC Medical Educationen
dc.identifier.urihttps://hdl.handle.net/10468/17336
dc.identifier.volume25
dc.language.isoenen
dc.publisherBioMed Central Ltden
dc.rights© 2025, the Author(s). Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/. en
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectCurriculumen
dc.subjectEarly-career researchersen
dc.subjectInvestigator-initiated trialsen
dc.subjectPractice-orienteden
dc.titleEnhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programmeen
dc.typeArticle (peer reviewed)en
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
s12909-025-07054-5.pdf
Size:
837.39 KB
Format:
Adobe Portable Document Format
Description:
Published Version
Download
Collections
Public Health - Journal Articles