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

J 2025

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

RYCHLÍČKOVÁ, Jitka; Zora ČECHOVÁ; Viktoria NAGY; Kateřina NEBESKÁ; Lenka SOUČKOVÁ et al.

Základní údaje

Originální název

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

Autoři

Vydání

BMC Medical Education, London, BMC, 2025, 1472-6920

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30230 Other clinical medicine subjects

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.200 v roce 2024

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/25:00141122

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

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

Štítky

14110516, 14119710, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 5. 5. 2025 14:23, Mgr. Tereza Miškechová

Anotace

V originále

IntroductionInvestigator-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.MethodsThe 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.ResultsA 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.ConclusionThis 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.

Návaznosti

LM2023049, projekt VaV

Název: Český národní uzel Evropské sítě infrastruktur klinického výzkumu

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, CZECRIN - Czech National Node to the European Clinical Research Infrastructure Network

2021-1-CZ01-KA220-HED-000023177, interní kód MU

Název: CONSCIOUS II Curriculum Development of Human Clinical Trials for the Next Generation Biomedical PhD Students and Early Career Researchers in Medicine, Pharmacy and Health Sciences (Akronym: CONSCIOUS 2)

Investor: Evropská unie, CONSCIOUS II Curriculum Development of Human Clinical Trials for the Next Generation Biomedical PhD Students and Early Career Researchers in Medicine, Pharmacy and Health Sciences, Strategická partnerství v oblasti vzdělávání, odborné přípravy a mládeže

Citovat

RYCHLÍČKOVÁ, Jitka; Zora ČECHOVÁ; Viktoria NAGY; Kateřina NEBESKÁ; Lenka SOUČKOVÁ; Stephane MOULY; Gabor Laszlo KOVACS; Christine KUBIAK; Eva TAKACS; Tiago H MOREIRA DE OLIVEIRA; Marco PAINHO; Emilia C MONTEIRO; Sara MAIA; Joana BATUCA a Frances SHIELY. Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme. BMC Medical Education. London: BMC, 2025, roč. 25, č. 1, s. 1-7. ISSN 1472-6920. Dostupné z: https://doi.org/10.1186/s12909-025-07054-5.

@article{2494924,
   author = {Rychlíčková, Jitka and Čechová, Zora and Nagy, Viktoria and Nebeská, Kateřina and Součková, Lenka and Mouly, Stephane and Kovacs, Gabor Laszlo and Kubiak, Christine and Takacs, Eva and Moreira de Oliveira, Tiago H and Painho, Marco and Monteiro, Emilia C and Maia, Sara and Batuca, Joana and Shiely, Frances},
   article_location = {London},
   article_number = {1},
   doi = {https://doi.org/10.1186/s12909-025-07054-5},
   keywords = {Investigator-initiated trials; Curriculum; Early-career researchers; Practice-oriented},
   language = {eng},
   issn = {1472-6920},
   journal = {BMC Medical Education},
   title = {Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme},
   url = {https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-025-07054-5},
   volume = {25},
   year = {2025}
}

TY  - JOUR
ID  - 2494924
AU  - Rychlíčková, Jitka - Čechová, Zora - Nagy, Viktoria - Nebeská, Kateřina - Součková, Lenka - Mouly, Stephane - Kovacs, Gabor Laszlo - Kubiak, Christine - Takacs, Eva - Moreira de Oliveira, Tiago H - Painho, Marco - Monteiro, Emilia C - Maia, Sara - Batuca, Joana - Shiely, Frances
PY  - 2025
TI  - Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme
JF  - BMC Medical Education
VL  - 25
IS  - 1
SP  - 1-7
EP  - 1-7
PB  - BMC
SN  - 14726920
KW  - Investigator-initiated trials
KW  - Curriculum
KW  - Early-career researchers
KW  - Practice-oriented
UR  - https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-025-07054-5
N2  - IntroductionInvestigator-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.MethodsThe 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.ResultsA 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.ConclusionThis 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.
ER  -

RYCHLÍČKOVÁ, Jitka; Zora ČECHOVÁ; Viktoria NAGY; Kateřina NEBESKÁ; Lenka SOUČKOVÁ; Stephane MOULY; Gabor Laszlo KOVACS; Christine KUBIAK; Eva TAKACS; Tiago H MOREIRA DE OLIVEIRA; Marco PAINHO; Emilia C MONTEIRO; Sara MAIA; Joana BATUCA a Frances SHIELY. Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme. \textit{BMC Medical Education}. London: BMC, 2025, roč.~25, č.~1, s.~1-7. ISSN~1472-6920. Dostupné z: https://doi.org/10.1186/s12909-025-07054-5.

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