Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme
Abstract 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, conduct...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-04-01
|
| Series: | BMC Medical Education |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12909-025-07054-5 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849737496724766720 |
|---|---|
| author | Jitka Rychlíčková Zora Čechová Viktoria Nagy Kateřina Nebeská Lenka Součková Stéphane Mouly Gabor Laszlo Kovacs Christine Kubiak Eva Takács Tiago H. Moreira de Oliveira Marco Painho Emília C. Monteiro Sara Maia Joana Batuca Frances Shiely |
| author_facet | Jitka Rychlíčková Zora Čechová Viktoria Nagy Kateřina Nebeská Lenka Součková Stéphane Mouly Gabor Laszlo Kovacs Christine Kubiak Eva Takács Tiago H. Moreira de Oliveira Marco Painho Emília C. Monteiro Sara Maia Joana Batuca Frances Shiely |
| author_sort | Jitka Rychlíčková |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-3ed66f7b33104f90baed7fd7b7b4b024 |
| institution | DOAJ |
| issn | 1472-6920 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Education |
| spelling | doaj-art-3ed66f7b33104f90baed7fd7b7b4b0242025-08-20T03:06:54ZengBMCBMC Medical Education1472-69202025-04-012511710.1186/s12909-025-07054-5Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programmeJitka Rychlíčková0Zora Čechová1Viktoria Nagy2Kateřina Nebeská3Lenka Součková4Stéphane Mouly5Gabor Laszlo Kovacs6Christine Kubiak7Eva Takács8Tiago H. Moreira de Oliveira9Marco Painho10Emília C. Monteiro11Sara Maia12Joana Batuca13Frances Shiely14Department of Pharmacology, Faculty of Medicine, Masaryk UniversityDepartment of Pharmacology, Faculty of Medicine, Masaryk UniversityUniversité Paris Cité, UFR EILACentre of Excellence, CREATIC at Masaryk UniversityDepartment of Pharmacology, Faculty of Medicine, Masaryk UniversityDépartment de Médecine Interne at Hopital Lariboisiere, Université Paris CitéSzentágothei Research Centre, University of PécsEuropean Clinical Research Infrastructure Network (ECRIN)Pharmaceutical Development and Clinical Research Competence Center, University of SzegedNOVA Information Management SchoolNOVA Information Management SchooliNOVA4Health, NOVA Medical School at Universidade NOVA de Lisboa, Portuguese Clinical Research Infrastructure NetworkClinical Coordinators Team in the NOVA Clinical Research Unit, NOVA Medical School, Universidade NOVA de LisboaiNOVA4Health, NOVA Medical School, Universidade NOVA de LisboaHRB Clinical Research Facility and School of Public Health, University College CorkAbstract 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.https://doi.org/10.1186/s12909-025-07054-5Investigator-initiated trialsCurriculumEarly-career researchersPractice-oriented |
| spellingShingle | Jitka Rychlíčková Zora Čechová Viktoria Nagy Kateřina Nebeská Lenka Součková Stéphane Mouly Gabor Laszlo Kovacs Christine Kubiak Eva Takács Tiago H. Moreira de Oliveira Marco Painho Emília C. Monteiro Sara Maia Joana Batuca Frances Shiely Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme BMC Medical Education Investigator-initiated trials Curriculum Early-career researchers Practice-oriented |
| title | Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme |
| title_full | Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme |
| title_fullStr | Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme |
| title_full_unstemmed | Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme |
| title_short | Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme |
| title_sort | enhancing pragmatic competence in investigator initiated clinical trials structure and evaluation of the conscious ii training programme |
| topic | Investigator-initiated trials Curriculum Early-career researchers Practice-oriented |
| url | https://doi.org/10.1186/s12909-025-07054-5 |
| work_keys_str_mv | AT jitkarychlickova enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT zoracechova enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT viktorianagy enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT katerinanebeska enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT lenkasouckova enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT stephanemouly enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT gaborlaszlokovacs enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT christinekubiak enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT evatakacs enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT tiagohmoreiradeoliveira enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT marcopainho enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT emiliacmonteiro enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT saramaia enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT joanabatuca enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme AT francesshiely enhancingpragmaticcompetenceininvestigatorinitiatedclinicaltrialsstructureandevaluationoftheconsciousiitrainingprogramme |