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[A survey on French hospital physicians'certification to the good clinical practices].
Therapie. 2020 Apr 19 [Online ahead of print]T

Abstract

Good clinical practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Before the start of a clinical trial, investigators commit to perform the research in accordance with GCPs, regulatory dispositions and protocol. The sponsors are responsible for investigators' selection and for controlling their skills. Whereas industrial sponsors systematically require a certificate of GCP training, academic sponsors seem to be less demanding. We have carried out two surveys between April and June 2018. A first questionnaire was sent to the 40 French academic directions of clinical research and innovation in order to determine their requirements about the GCP training of the investigators participating in their trials. The second questionnaire was transmitted to physicians of the "Bretagne recherche clinique hospitalière network": Rennes, Saint-Malo, Saint-Brieuc, Vannes, Lorient and Pontivy hospitals, in order to determine the GCP certification rate, and their needs in terms of clinical research training. Twenty-eight (70%) directions of clinical research answered the first survey, among which 18 (64%) required systematically the investigators' GCP certification in case of category 1 interventional studies. This rate decreased for category 2 (50%) and non-interventional category 3 (18%) studies. A total of 345 physicians answered the second survey, among which 263 (76%) had already been clinical trial investigators. However, only 29% of all physicians and 54% of those who had been principal investigator were certified for GCP training. These results support the need for large campaigns of GCP training in public hospitals.

Authors+Show Affiliations

Service de pharmacologie clinique, CHU de Rennes, 35000 Rennes, France; CIC 1414, Inserm, centre d'investigation clinique de Rennes, 35000 Rennes, France. Electronic address: claire.fougerou@chu-rennes.fr.Service de pharmacologie clinique, CHU de Rennes, 35000 Rennes, France; CIC 1414, Inserm, centre d'investigation clinique de Rennes, 35000 Rennes, France.Service de pharmacologie clinique, CHU de Rennes, 35000 Rennes, France; CIC 1414, Inserm, centre d'investigation clinique de Rennes, 35000 Rennes, France.Service de pharmacologie clinique, CHU de Rennes, 35000 Rennes, France; CIC 1414, Inserm, centre d'investigation clinique de Rennes, 35000 Rennes, France.Unité de recherche clinique, centre hospitalier de Lorient, 56322 Lorient, France.Centre de recherche clinique, centre hospitalier de Bretagne Atlantique, 56017 Vannes, France.Institut de formation des professionnels de santé, 56017 Vannes, France.Unité de recherche clinique, centre hospitalier de Saint-Brieuc, 22000 Saint-Brieuc, France.Unité de recherche clinique, CHSP Guillaume Régnier, 35700 Rennes, France.Unité de recherche clinique, centre hospitalier de Saint-Malo, 35400 Saint-Malo, France.Direction des affaires médicales, centre hospitalier de Centre Bretagne, 56920 Noyal-Pontivy, France.Direction de la recherche clinique, CHU de Rennes, 35000 Rennes, France.Service de pharmacologie clinique, CHU de Rennes, 35000 Rennes, France; CIC 1414, Inserm, centre d'investigation clinique de Rennes, 35000 Rennes, France; Université Rennes, 35000 Rennes, France.Service de pharmacologie clinique, CHU de Rennes, 35000 Rennes, France; CIC 1414, Inserm, centre d'investigation clinique de Rennes, 35000 Rennes, France; Université Rennes, 35000 Rennes, France.

Pub Type(s)

English Abstract
Journal Article

Language

fre

PubMed ID

32409207

Citation

Fougerou-Leurent, Claire, et al. "[A Survey On French Hospital Physicians'certification to the Good Clinical Practices]." Therapie, 2020.
Fougerou-Leurent C, Chesnais J, Nekmouche S, et al. [A survey on French hospital physicians'certification to the good clinical practices]. Therapie. 2020.
Fougerou-Leurent, C., Chesnais, J., Nekmouche, S., Veislinger, A., Le Saux, M., Joumard, C., Lorre, V., Bellot, C., Alleton, N., Labourdette, E., Marie, C., Fin, L., Bellissant, E., & Laviolle, B. (2020). [A survey on French hospital physicians'certification to the good clinical practices]. Therapie. https://doi.org/10.1016/j.therap.2020.04.002
Fougerou-Leurent C, et al. [A Survey On French Hospital Physicians'certification to the Good Clinical Practices]. Therapie. 2020 Apr 19; PubMed PMID: 32409207.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [A survey on French hospital physicians'certification to the good clinical practices]. AU - Fougerou-Leurent,Claire, AU - Chesnais,Jimmy, AU - Nekmouche,Sabrina, AU - Veislinger,Aurélie, AU - Le Saux,Mariella, AU - Joumard,Céline, AU - Lorre,Véronique, AU - Bellot,Catherine, AU - Alleton,Nathalie, AU - Labourdette,Elodie, AU - Marie,Carole, AU - Fin,Loïc, AU - Bellissant,Eric, AU - Laviolle,Bruno, Y1 - 2020/04/19/ PY - 2019/10/02/received PY - 2020/01/28/revised PY - 2020/04/09/accepted PY - 2020/5/16/entrez KW - Bonnes pratiques cliniques KW - Certification KW - Clinical trial KW - Essais cliniques KW - Formation KW - Good clinical practices KW - Investigateur KW - Investigator KW - Promotion KW - Sponsoring KW - Training JF - Therapie JO - Therapie N2 - Good clinical practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Before the start of a clinical trial, investigators commit to perform the research in accordance with GCPs, regulatory dispositions and protocol. The sponsors are responsible for investigators' selection and for controlling their skills. Whereas industrial sponsors systematically require a certificate of GCP training, academic sponsors seem to be less demanding. We have carried out two surveys between April and June 2018. A first questionnaire was sent to the 40 French academic directions of clinical research and innovation in order to determine their requirements about the GCP training of the investigators participating in their trials. The second questionnaire was transmitted to physicians of the "Bretagne recherche clinique hospitalière network": Rennes, Saint-Malo, Saint-Brieuc, Vannes, Lorient and Pontivy hospitals, in order to determine the GCP certification rate, and their needs in terms of clinical research training. Twenty-eight (70%) directions of clinical research answered the first survey, among which 18 (64%) required systematically the investigators' GCP certification in case of category 1 interventional studies. This rate decreased for category 2 (50%) and non-interventional category 3 (18%) studies. A total of 345 physicians answered the second survey, among which 263 (76%) had already been clinical trial investigators. However, only 29% of all physicians and 54% of those who had been principal investigator were certified for GCP training. These results support the need for large campaigns of GCP training in public hospitals. SN - 1958-5578 UR - https://www.unboundmedicine.com/medline/citation/32409207/[A_survey_on_French_hospital_physicians'certification_to_the_good_clinical_practices] L2 - https://linkinghub.elsevier.com/retrieve/pii/S0040-5957(20)30066-4 DB - PRIME DP - Unbound Medicine ER -
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