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Outpatient healthcare and clinical trials in the care pathway: Organisational and regulatory aspects and tools - 17/02/22

Doi : 10.1016/j.therap.2022.01.004 
Bruno Laviolle a, Vincent Diebolt b, , Luc Duchossoy c, Xavier Anglaret d, 1, Jehan-Michel Béhier e, 1, Pierre-Henri Bertoye f, 1, Anthony Chapron g, 1, Denis Comet h, 1, Catherine Cornu i, 1, Cécile Fouret j, 1, Anne Galaup k, 1, Aurélie Guérin l, 1, Bruno Hoen m, 1, Patrick Imbert n, 1, Marie Lang o, 1, Anne Le Louarn o, 1, Bastien Mezerette p, 1, Sophie Sénéchal q, 1, Tabassome Simon r, 1, Pierre Traineau s, 1
a Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d’investigation clinique de Rennes, service de pharmacologie clinique), Irset (Institut de recherche en santé, environnement et travail) - UMR_S 1085, EHESP, 35000 Rennes, France 
b F-CRIN, Pavillon Leriche, Hôpital Purpan (CHU de Toulouse), Place du Dr Blayac, 31059 Toulouse, France 
c Sanofi Aventis France, 94250 Gentilly, France 
d CHU de Bordeaux, 33000 Bordeaux, France 
e BMS, 92500 Rueil Malmaison, France 
f Unicancer, 75013 Paris, France 
g Université de Rennes, CHU de Rennes, INSERM CIC1414, 35000 Rennes, France 
h AFCROs & Axonal Biostatem, 92024 Nanterre, France 
i INSERM CIC 1407 UMR 5558, université Claude Bernard, 69000 Lyon, France 
j Medtronic, 92100 Boulogne-Billancourt, France 
k LEEM, 75858 Paris, France 
l Pfizer, 75014 Paris, France 
m Institut Pasteur, 75015 Paris, France 
n CNGE, 94300 Vincennes, France 
o CNCR, 75014 Paris, France 
p GIRCI, Île-de-France, 75019 Paris, France 
q Astrazeneca, 92400 Courbevoie, France 
r Pharmacologie clinique, hôpital Saint Antoine, AP–HP, 75012 Paris, France 
s Esante Catel, 56000 Vannes, France 

Corresponding author.

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Summary

Clinical research in outpatient healthcare, particularly in general practice, which is the first line of contact with the population, is now a public health issue. However, this type of research has specific characteristics that differentiate it from clinical research conducted in a hospital setting and requires an adaptation of its conditions of practice: in terms of organisation, the development of research in outpatient healthcare relies on the appropriation of its fundamentals by the investigators, which implies their presentation, upstream, from the initial cycle, and the participation of practitioners in training modules adapted to research in primary care, such as those already organised by several GIRCI (Groupement Inter régional de la Recherche Clinique et de l’Innovation [French Interregional Clusters for Clinical Research and Innovation]). To compensate for the fragmented nature of their location, on the model of the EMRCs (équipes mobiles de recherche clinique [mobile clinical research teams]) in oncology, mobile research teams should enable general medical practices to participate in clinical trials. This presupposes, on the one hand, the allocation of earmarked funding to ensure the sustainability of a base of dedicated personnel and, on the other hand, the impetus of a national dynamic through the setting up of a multi-organisation thematic institute for “research in primary care” associated, at the operational level, with a national scale investigation network supported by a platform of excellence. The use of digital tools and innovations (telemedicine; data collection via connected tools; e-consent; electronic signature) which make it possible to digitise and relocate all or part of the research procedures for both the participant and the investigation teams. An adaptation of the legal framework in order to bring the place of research closer to the patient and not the other way round, which means moving the equipment and investigations closer to the patient. Taking into account the acceptability of the patient, thus limiting the disruption that may be caused by his or her participation in a research protocol and motivating the practitioner by valuing his or her contribution and providing all the guarantees of scientific relevance and independence of practice. In view of the contextual analysis, positive feedback and the availability of organisational and digital support points facilitating the delocalisation and digitisation of the conduct of research activity as close as possible to the patient and his or her doctor, the round table concluded that opportunities exist today which favour the development of clinical research in general practice. It is important to seize this opportunity and make the most of it without delay.

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Keywords : Clinical research, General practice, Training, Motivation, Mobile teams, Digitalisation, Digitisation, Patient, Acceptability


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© 2022  Pubblicato da Elsevier Masson SAS.
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Vol 77 - N° 1

P. 37-48 - Gennaio 2022 Ritorno al numero
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