Enhancing pragmatic competence in investigator-initiated clinical trials
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2025 |
| Outros Autores: | , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) |
| Texto Completo: | http://hdl.handle.net/10362/182283 |
Resumo: | 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). |
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Enhancing pragmatic competence in investigator-initiated clinical trialsstructure and evaluation of the CONSCIOUS II training programmeInvestigator-initiated trialsCurriculumEarly-career researchersPractice-orientedEducationRychlíčková, 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).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.NOVA Information Management School (NOVA IMS)Information Management Research Center (MagIC) - NOVA Information Management SchooliNOVA4Health - pólo NMSNOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNRychlíčková, JitkaČechová, ZoraNagy, ViktoriaNebeská, KateřinaSoučková, LenkaMouly, StéphaneKovacs, Gabor LaszloKubiak, ChristineTakács, EvaMoreira de Oliveira, Tiago H.Painho, MarcoMonteiro, Emília C.Maia, SaraBatuca, JoanaShiely, Frances2025-04-14T21:12:10Z2025-04-082025-04-08T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article7application/pdfhttp://hdl.handle.net/10362/182283eng1472-6920PURE: 114949175https://doi.org/10.1186/s12909-025-07054-5info:eu-repo/semantics/openAccessreponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiainstacron:RCAAP2025-05-12T01:45:33Zoai:run.unl.pt:10362/182283Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireinfo@rcaap.ptopendoar:https://opendoar.ac.uk/repository/71602025-05-29T06:29:51.212578Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiafalse |
| dc.title.none.fl_str_mv |
Enhancing pragmatic competence in investigator-initiated clinical trials structure and evaluation of the CONSCIOUS II training programme |
| title |
Enhancing pragmatic competence in investigator-initiated clinical trials |
| spellingShingle |
Enhancing pragmatic competence in investigator-initiated clinical trials Rychlíčková, Jitka Investigator-initiated trials Curriculum Early-career researchers Practice-oriented Education |
| title_short |
Enhancing pragmatic competence in investigator-initiated clinical trials |
| title_full |
Enhancing pragmatic competence in investigator-initiated clinical trials |
| title_fullStr |
Enhancing pragmatic competence in investigator-initiated clinical trials |
| title_full_unstemmed |
Enhancing pragmatic competence in investigator-initiated clinical trials |
| title_sort |
Enhancing pragmatic competence in investigator-initiated clinical trials |
| author |
Rychlíčková, Jitka |
| author_facet |
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 |
| author_role |
author |
| author2 |
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 |
| author2_role |
author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
NOVA Information Management School (NOVA IMS) Information Management Research Center (MagIC) - NOVA Information Management School iNOVA4Health - pólo NMS NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) RUN |
| dc.contributor.author.fl_str_mv |
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 |
| dc.subject.por.fl_str_mv |
Investigator-initiated trials Curriculum Early-career researchers Practice-oriented Education |
| topic |
Investigator-initiated trials Curriculum Early-career researchers Practice-oriented Education |
| description |
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). |
| publishDate |
2025 |
| dc.date.none.fl_str_mv |
2025-04-14T21:12:10Z 2025-04-08 2025-04-08T00:00:00Z |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
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http://hdl.handle.net/10362/182283 |
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http://hdl.handle.net/10362/182283 |
| dc.language.iso.fl_str_mv |
eng |
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eng |
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1472-6920 PURE: 114949175 https://doi.org/10.1186/s12909-025-07054-5 |
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info:eu-repo/semantics/openAccess |
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openAccess |
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7 application/pdf |
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