Building key competencies clinical trialists of the future:
CONSCIOUS curriculum projects

k 2023

Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects

RYCHLÍČKOVÁ, Jitka, Joana R BATUCA, Viktória NAGY, Frances SHIELY, Zora ČECHOVÁ et. al.

Basic information

Original name

Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects

Name in Czech

Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects

Authors

RYCHLÍČKOVÁ, Jitka (203 Czech Republic, guarantor, belonging to the institution), Joana R BATUCA (620 Portugal), Viktória NAGY (250 France), Frances SHIELY (372 Ireland), Zora ČECHOVÁ (203 Czech Republic, belonging to the institution), Kateřina NEBESKÁ (203 Czech Republic, belonging to the institution), Lenka SOUČKOVÁ (203 Czech Republic), Stephane MOULY (250 France), Gábor L. KOVÁCS (348 Hungary), Annamária NÉMETH (348 Hungary), Tiago OLIVEIRA (620 Portugal), Marco PAINHO (620 Portugal), Sara MAIA (620 Portugal) and Emília C. MONTEIRO (620 Portugal)

Edition

ORPHEUS 2023: Putting the i’s and o’s in doctoral training; International, Intersectoral, Interdisciplinary, and Open Science, 2023

Other information

Language

English

Type of outcome

Prezentace na konferencích

Field of Study

30104 Pharmacology and pharmacy

Country of publisher

Czech Republic

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

RIV identification code

RIV/00216224:14110/23:00130592

Organization unit

Faculty of Medicine

Keywords in English

clinical trials

Abstract

V originále

Investigator-initiated clinical trials (IIT) are a broadly interprofessional field that is becoming increasingly relevant to biomedical postgraduate students, especially to validate their research question in clinical practice. Indeed, IIT represent a way to develop individualized treatment and obtain objective evidence to answer questions of day-to-day practice. On the other hand, IIT place greater demands on investigators as they extend their position to include the coordination and management role of the sponsor. At the same time, little formal training in clinical trials is available across European countries in both undergraduate and postgraduate education, and the understanding of biomedical graduates in clinical research organization may not be optimal. A consortium of six European universities was established to fill this gap by preparing a highly practice-based and -oriented curriculum within two consequent projects – CONSCIOUS and CONSCIOUS II. Especially the CONSCIOUS II is focused on postgraduate students and provides them with e-learning lessons of practical guidance on how to design a research question and a clinical trial, the regulatory requirements that need to be met, how to conduct the trial, what activities can be delegated, and how to analyze the results. The second part targets transdisciplinary skills such as leadership, publishing, and teaching. The CONSCIOUS II pedagogical approach moves on to contextualized, case-based exercises allowing to test the acquired skills in simulated situations. Both CONSCIOUS projects thus offer a comprehensive, free-of-charge curriculum for biomedical students but will also open a pilot course with international participation as a further extension of this curriculum.

Links

LM2023049, research and development project

Name: Český národní uzel Evropské sítě infrastruktur klinického výzkumu

Investor: Ministry of Education, Youth and Sports of the CR

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

Name: 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 (Acronym: CONSCIOUS 2)

Investor: European Union, Strategic Partnerships in the field of education, training and youth

Citovat

RYCHLÍČKOVÁ, Jitka, Joana R BATUCA, Viktória NAGY, Frances SHIELY, Zora ČECHOVÁ, Kateřina NEBESKÁ, Lenka SOUČKOVÁ, Stephane MOULY, Gábor L. KOVÁCS, Annamária NÉMETH, Tiago OLIVEIRA, Marco PAINHO, Sara MAIA and Emília C. MONTEIRO. Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects. In ORPHEUS 2023: Putting the i’s and o’s in doctoral training; International, Intersectoral, Interdisciplinary, and Open Science. 2023.

@proceedings{2275537,
   author = {Rychlíčková, Jitka and Batuca, Joana R and Nagy, Viktória and Shiely, Frances and Čechová, Zora and Nebeská, Kateřina and Součková, Lenka and Mouly, Stephane and Kovács, Gábor L. and Németh, Annamária and Oliveira, Tiago and Painho, Marco and Maia, Sara and Monteiro, Emília C.},
   booktitle = {ORPHEUS 2023: Putting the i’s and o’s in doctoral training; International, Intersectoral, Interdisciplinary, and Open Science},
   keywords = {clinical trials},
   language = {eng},
   title = {Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects},
   url = {https://orpheus-med.org/conferences/},
   year = {2023}
}

TY  - CONF
ID  - 2275537
AU  - Rychlíčková, Jitka - Batuca, Joana R - Nagy, Viktória - Shiely, Frances - Čechová, Zora - Nebeská, Kateřina - Součková, Lenka - Mouly, Stephane - Kovács, Gábor L. - Németh, Annamária - Oliveira, Tiago - Painho, Marco - Maia, Sara - Monteiro, Emília C.
PY  - 2023
TI  - Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects
KW  - clinical trials
UR  - https://orpheus-med.org/conferences/
N2  - Investigator-initiated clinical trials (IIT) are a broadly interprofessional field that is becoming increasingly relevant to biomedical postgraduate students, especially to validate their research question in clinical practice. Indeed, IIT represent a way to develop individualized treatment and obtain objective evidence to answer questions of day-to-day practice. On the other hand, IIT place greater demands on investigators as they extend their position to include the coordination and management role of the sponsor. At the same time, little formal training in clinical trials is available across European countries in both undergraduate and postgraduate education, and the understanding of biomedical graduates in clinical research organization may not be optimal. A consortium of six European universities was established to fill this gap by preparing a highly practice-based and -oriented curriculum within two consequent projects – CONSCIOUS and CONSCIOUS II. Especially the CONSCIOUS II is focused on postgraduate students and provides them with e-learning lessons of practical guidance on how to design a research question and a clinical trial, the regulatory requirements that need to be met, how to conduct the trial, what activities can be delegated, and how to analyze the results. The second part targets transdisciplinary skills such as leadership, publishing, and teaching. The CONSCIOUS II pedagogical approach moves on to contextualized, case-based exercises allowing to test the acquired skills in simulated situations. Both CONSCIOUS projects thus offer a comprehensive, free-of-charge curriculum for biomedical students but will also open a pilot course with international participation as a further extension of this curriculum.
ER  -

RYCHLÍČKOVÁ, Jitka, Joana R BATUCA, Viktória NAGY, Frances SHIELY, Zora ČECHOVÁ, Kateřina NEBESKÁ, Lenka SOUČKOVÁ, Stephane MOULY, Gábor L. KOVÁCS, Annamária NÉMETH, Tiago OLIVEIRA, Marco PAINHO, Sara MAIA and Emília C. MONTEIRO. Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects. In \textit{ORPHEUS 2023: Putting the i’s and o’s in doctoral training; International, Intersectoral, Interdisciplinary, and Open Science}. 2023.

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