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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00159816%3A_____%2F25%3A00082270" target="_blank" >RIV/00159816:_____/25:00082270 - isvavai.cz</a>

Alternative codes found

RIV/00216224:14110/25:00141104

Result on the web

<a href="https://link.springer.com/article/10.1186/s12909-025-07054-5" target="_blank" >https://link.springer.com/article/10.1186/s12909-025-07054-5</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1186/s12909-025-07054-5" target="_blank" >10.1186/s12909-025-07054-5</a>

Result language

angličtina

Original language name

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

Original language description

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&apos; 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.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

50302 - Education, special (to gifted persons, those with learning disabilities)

Project

<a href="/en/project/LM2023049" target="_blank" >LM2023049: Czech National Node of the European Clinical Research Infrastructures Network</a><br>

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

BMC Medical Education

ISSN

1472-6920

e-ISSN

1472-6920

Volume of the periodical

25

Issue of the periodical within the volume

1

Country of publishing house

GB - UNITED KINGDOM

Number of pages

7

Pages from-to

nestránkováno

UT code for WoS article

001463110200007

EID of the result in the Scopus database

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