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For the past few years, platform trials have experienced a significant increase, recently amplified by the COVID-19 pandemic. The implementation of a platform trial is particularly useful in certain pathologies, particularly when there is a significant number of drug candidates to be assessed, a rapid evolution of the standard of care or in situations of urgent need for evaluation, during which the pooling of protocols and infrastructure optimizes the number of patients to be enrolled, the costs, and the deadlines for carrying out the investigation. However, the specificity of platform trials raises methodological, ethical, and regulatory issues, which have been the subject of the round table and which are presented in this article. The round table was also an opportunity to discuss the complexity of sponsorship and data management related to the multiplicity of partners, funding, and governance of these trials, and the level of acceptability of their findings by the competent authorities.

OLGA (which stands for "Activity Management Tool" in French) is a digital management platform developed by F-CRIN, the French Clinical Research Infrastructure Network, which was set up in 2012 to improve the performance and attractiveness of clinical research in France. F-CRIN currently represents a community made up of 21 different components - thematic research, investigation and research networks with a national scope - bringing together the equivalent of 1,500 clinical researchers and 400 research centres all around the country and belonging to many different organizations. Faced with the difficulty of gathering uniform collective data that meet the requirements of F-CRIN's supervisory authorities, in 2015 the F-CRIN community decided to develop a specific monitoring and management tool. Designed with input from its future users, OLGA currently has two modules: one for the components' research activity and the other for their financial operations, resources and expenses. These are able to take account of the activity of the components in all their diversity and produce various sets of indicators. Other features, including a space for sharing documents, are currently being developed. Today, OLGA is a reference tool for managing large-scale, complex organisations.

Resume La radioprotection a fait l’objet d’une reevaluation par l’autorite de surete nucleaire (ASN) suite a une enquete de pratiques sur le terrain montrant d’importantes insuffisances de precautions, et pour se mettre en accord avec les nouvelles directives europeennes. Les rhumatologues sont de moins en moins impliques avec le choix de la nouvelle generation de jeunes rhumatologues de privilegier l’approche echographique, tant a visee diagnostique qu’interventionnelle. Cependant, les rayonnements X resteront de mise pour visualiser le tissu osseux et pratiquer des gestes interventionnels a ce niveau, et l’absorptiometrie, bien qu’extremement peu irradiante, est egalement concernee, tout comme la pratique de synoviortheses isotopiques. Enfin, les rhumatologues restent des prescripteurs d’examens ou d’actes interventionnels realises sous controle visuel grâce aux rayonnements X. Ceux qui seront exposes aux rayonnements ionisants devront respecter les nouvelles reglementations, acquerir un materiel adequat, respecter des procedures preetablies, et valider une formation de radioprotection vis-a-vis des patients d’une journee tous les 7 ans en France.

Resume L’intelligence artificielle (IA), au-dela des applications concretes qui ont deja integre notre quotidien, permet de traiter des donnees et des connaissances nombreuses et heterogenes, et de comprendre des regles potentiellement complexes et abstraites a la maniere de l’intelligence humaine mais sans intervention de sa part. Elle conjugue deux proprietes, l’auto-apprentissage d’abord par le traitement successif et repetitif de donnees et, une capacite d’adaptabilite, c’est-a-dire la possibilite pour un programme code de traiter des situations multiples susceptibles de varier au cours du temps. Les experts de la table ronde ont confirme l’apport potentiel et le benefice theorique que represente l’IA en recherche clinique et en matiere d’amelioration de l’efficience des soins. Ils ont pu mesurer egalement, comme c’est le cas pour tout processus nouveau qu’il faut acclimater et apprivoiser, son impact sur les pratiques et les mentalites. Pour en maximiser les benefices, quatre points critiques ont ete identifies. Leur prise en compte conditionne l’integration technique et l’appropriation par tous les acteurs de la recherche, instances de regulation, industries en sante, etablissements et reseaux de sante sans, surtout, oublier les patients et la societe civile : 1er point critique : reunir les elements de preuve des benefices de l’apport de l’IA en recherche clinique et pouvoir les quantifier ; 2e point critique : creer un climat de confiance pour garantir la diffusion et l’acceptabilite de l’IA en recherche en sante, dans un contexte reglementaire adapte ; 3e point critique : assurer la disponibilite des competences techniques, ce qui implique un investissement en formation, l’attractivite du secteur de la sante et le developpement d’outils ergonomiques de collecte des donnees aupres de l’ensemble des operateurs de sante ; 4e point critique : se mettre en ordre de marche, c’est-a-dire assurer l’organisation et la gouvernance d’un modele reparti et securise a l’echelon national pour faire converger l’information et les services dont beneficie le patient au niveau territorial et regional. Au final trente-sept recommandations concretes ont ete formulees qui doivent permettre l’acclimatation de l’IA en recherche clinique, sachant que la mise en place du « health data hub » constitue une opportunite ideale.

The constant development of health technologies, combined with the increase in the cost of treatment, means that States must continually make choices about the introduction of new technologies into their healthcare system and how they are to be funded. In France, the systematic participation of patients in these processes is one of the targets to be met in terms of healthcare democracy. Although, on an international level, patient involvement in these assessments is constantly growing, it is difficult to define due to the presence of unstabilised elements in terms of both terminology and assessment methods. As a result, patient and public involvement in health technology assessments varies considerably from one country to the next, from one field to the next and even from one type of technology to the next. Several types of involvement exist, ranging from studies conducted to collect patient "insight" (experience, perception, needs, preferences, attitudes to treatment and health, etc.) to processes aimed at including patients in assessments (as individuals, as representatives of associations, etc.). Given the scope and complexity of the subject, and the difficulty involved in understanding all the different aspects of health technologies and innovations, the members of the Round Table chose to concentrate on health technology assessments (medicinal products and medical devices) to develop national recommendations on all possible types of patient involvement in the health technology assessment processes conducted by the health authorities in France.

Resume Le developpement permanent de technologies de sante, associe a l’augmentation du cout des prises en charge impose aux Etats des arbitrages permanents vis-a-vis de l’introduction des nouvelles technologies dans leur systeme de soin et du choix de leurs modalites de financement. En France, la generalisation de la participation des patients dans ces processus est l’un des objectifs a atteindre dans le cadre de la democratie sanitaire. Or, bien qu’a l’echelle internationale le theme de l’implication des patients dans ces evaluations soit en pleine croissance, il peine encore a se definir du fait d’elements non stabilises, qu’il s’agisse des terminologies ou des methodes d’evaluation. Ainsi, l’implication des patients et du public dans les evaluations des technologies de sante reste tres inegale d’un pays a l’autre, d’un domaine a l’autre, voire d’un type de technologie a l’autre. Par ailleurs, il existe plusieurs formes d’implication possibles, qu’il s’agisse du recours a des etudes permettant de recueillir leur « point de vue » (experience, perceptions, besoins, preferences, attitudes a propos des soins et de la sante, …) ou de processus ayant pour but de les faire participer aux evaluations (en tant qu’individus, en tant que representants d’associations, …). Devant l’etendue et la complexite du sujet, et les difficultes a apprehender toutes les facettes des technologies de sante et des innovations, les membres de la table ronde ont centre leur reflexion sur les evaluations des produits de sante (medicaments et dispositifs medicaux) pour aboutir a l’elaboration de recommandations a portee nationale sur toutes les formes d’implication possible des patients dans les processus d’evaluation des produits de sante faites par les autorites de sante en France.

Resume L’acces au marche des medicaments innovants en France comporte une evaluation medico-economique (amelioration du service medical rendu/amelioration du service attendu [ASMR/ASA] I, II, III avec impacts significatifs sur les depenses d’assurance-maladie). En sus d’une analyse cout-resultat (ACR), des analyses d’impact budgetaire (AIB) peuvent etre produites d’autant plus que la soutenabilite du systeme d’assurance-maladie est une preoccupation croissante de l’ensemble des parties prenantes francaises. Les reflexions menees par les participants de la table ronde de Giens 2016 ont porte sur les analyses d’impact budgetaire et se sont basees sur une revue de litterature menee sur les modeles de diffusion, l’experience des participants dont celle liee aux modalites d’evaluation a l’hopital et des experiences etrangeres. La table ronde a permis de degager des recommandations sur 4 elements d’interet : 1 : l’utilisation des AIB tant d’un point de vue contractuel entre les industriels et le Comite economique des produits de sante (CEPS) a l’occasion des negociations prix que d’un point de vue de prospectives dans le cadre du suivi annuel des depenses budgetaires ; la definition de la population-cible et du rythme de diffusion du produit de sante etant aussi un element majeur ; 2 : l’interpretation des resultats des AIB au regard des resultats d’ACR, pour quels produits et a quel moment de leur cycle de vie ; 3 : l’integration du rythme de diffusion des produits de sante dans les AIB, et enfin 4 : la preoccupation de discuter le niveau d’implementation des produits de sante dans l’AIB tant en termes de cout d’opportunite, de qualite et d’organisation pour la promouvoir.

International audience; Artificial intelligence (AI), beyond the concrete applications that have already become part of our daily lives, makes it possible to process numerous and heterogeneous data and knowledge, and to understand potentially complex and abstract rules in a manner human intelligence can but without human intervention. AI combines two properties, self-learning by the successive and repetitive processing of data as well as the capacity to adapt, that is to say the possibility for a scripted program to deal with multiple situations likely to vary over time. Roundtable experts confirmed the potential contribution and theoretical benefit of AI in clinical research and in improving the efficiency of patient care. Experts also measured, as is the case for any new process that people need to get accustomed to, its impact on practices and mindset. To maximize the benefits of AI, four critical points have been identified. The careful consideration of these four points conditions the technical integration and the appropriation by all actors of the life science spectrum: researchers, regulators, drug developers, care establishments, medical practitioners and, above all, patients and the civil society. 1st critical point: produce tangible demonstrations of the contributions of AI in clinical research by quantifying its benefits. 2nd critical point: build trust to foster dissemination and acceptability of AI in healthcare thanks to an adapted regulatory framework. 3rd critical point: ensure the availability of technical skills, which implies an investment in training, the attractiveness of the health sector relative to tech-heavy sectors and the development of ergonomic data collection tools for all health operators. 4th critical point: organize a system of governance for a distributed and secure model at the national level to aggregate the information and services existing at the local level. Thirty-seven concrete recommendations have been formulated which should pave the way for a widespread adoption of AI in clinical research. In this context, the French "Health data hub" initiative constitutes an ideal opportunity.

The Giens 2015 Workshop Round Table entitled "What specifications for a centre or network of excellence in clinical research?" took a viewpoint distinct from earlier work and studies on changes in clinical research activities in France. The purpose of the present work was to identify, starting from concrete examples, the main strengths and advantages of clinical research activity in France related, in part, to the background environment and also to the specific characteristics of the investigation centres considered to be among the most high-performance units in activity. The criteria retained were grouped into a set of specifications that could be used to establish a "label of excellence" upon which the different teams and clinical research centres could model themselves. It was thus considered that belonging to a centre or structured network with at least a national configuration, when this is possible for the medial topic in question, constitutes a real advantage. Four benchmarks were identified: the scientific and clinical expertise of the head investigator, as well as the qualification and operational capacity of the centre's team; definition and measurement of performance using clearly displayed indicators and evaluation procedures; the quality of the overall trial "process" and of each of its component steps; communication, because know-how and promotion go hand in hand, with the main objective of informing the professional and general public about the value of the research centre meeting the above-mentioned criteria, about its networks of competencies, and more generally, about the important assets of the background of clinical research in France. This sector of research is funded by the public authorities via calls for public grants, financial aids for structures supporting clinical research in the University Hospital Centres and other healthcare institutions allowing for a professionalization of the research occupations, and the national public health plans (cancer, rare disease, HIV).

Resume Le parti pris de la table ronde « Quel cahier des charges pour un centre ou un reseau d’excellence en recherche clinique ? » se distingue des travaux et etudes precedemment realises sur l’evolution de l’activite de recherche clinique en France. L’objectif de ce travail a ete d’identifier, en s’appuyant sur des exemples concrets, les atouts et les points forts de cette activite, lies, d’une part, a son environnement et, d’autre part, aux caracteristiques des centres d’investigation consideres comme parmi les plus performants. L’ensemble des criteres retenus doit constituer un cahier des charges qui serait en quelque sorte un « label d’excellence » auquel l’ensemble des equipes et des centres de recherche clinique pourront se referer. Il a ete ainsi considere que l’appartenance d’un centre a un reseau de recherche structure et a minimum d’envergure nationale, s’il en existe bien sur dans la thematique medicale concernee, constituait une valeur ajoutee. Cette « carte d’identite » s’articule autour de 4 valeurs de reference, chacune d’entre elles se declinant en plusieurs criteres : l’expertise scientifique et clinique de l’investigateur ainsi que la qualification et la capacite operationnelle de l’equipe du centre ; la definition et la mesure de la performance au travers d’indicateurs et de procedures d’evaluation clairement affiches ; la qualite du process de conduite d’essais cliniques pris dans sa globalite, a chaque etape de sa realisation ; la communication, car il s’agit non seulement de « savoir-faire » mais egalement de « faire-savoir » avec l’objectif principal de valoriser aupres de l’ensemble des publics, professionnels ou non, le centre de recherche qui repond a l’ensemble des criteres precites, le reseau de competences dans lequel il s’integre et d’une maniere generale, les atouts du « terreau » de la recherche clinique en France. Ce secteur est financierement soutenu par les pouvoirs publics dans le cadre d’appels d’offres recurrents, de financement de structure de soutien a la recherche clinique dans les centres hospitaliers universitaires et autres etablissements de sante permettant une professionnalisation des metiers de la recherche et dans le cadre de plan nationaux de sante publique (Plan cancer, maladies rares, VIH).

Resume Le lancement d’Horizon 2020, 8 e programme cadre de recherche et de developpement (PCRD) de l’Union Euro-peenne, dote de 79 milliards d’euros, est l’occasion de faire le bilan de la participation de la France aux precedents PCRD. Elle n’est a la hauteur ni de son poids scientifique, ni de son investissement financier. Alors que la France a contribue au budget recherche de l’Union Europeenne (7 e PCRD) a hauteur de 16,5 a 17 %, le retour monetaire assure par le financement de projets coordonnes auxquels ses equipes participent est de l’ordre de 12,5 a 13 %. C’est un manque a gagner de 600 millions d’euros. Meme si la situation doit etre nuancee par type d’activite, la France, en recherche clinique, apparait en retrait et moins engagee dans les appels a projets europeens par comparaison avec ses voisins. Si la France possede des atouts (financement assure de la recherche clinique, structuration de reseaux thematiques, lancement de grands plans nationaux), elle est penalisee par l’eparpillement des ressources au nom de la politique d’amenagement du territoire, le manque d’approche multidisciplinaire et la meconnaissance du fonctionnement de Horizon 2020 par la communaute medicale et scientifique et les institutions auxquelles elles appartiennent. Les solutions envisagees pour inciter au depot de projets coordonnes ou associant des equipes francaises en recherche clinique et aider a leur montage sont de trois ordres : • elargir la vision de nos enfants, etudiants et collaborateurs et les aider a s’adapter a la mondialisation des connaissances tout au long de leur cheminement educatif et professionnel ; • valoriser les actions europeennes pour agir sur le contexte europeen et faire evoluer les mentalites ; • aider et accompagner les porteurs de projets en mutualisant les competences autour d’un nombre limite de centres d’expertise d’aide au montage.

Resume La recherche clinique est un enjeu majeur pour notre societe moderne, demandant toujours plus de preuves scientifiques pour accompagner le progres quece soit au travers du developpement de nouveaux produits de sante, que dans l’amelioration des pratiques cliniques, de protocoles de soins ou de prevention. Cette recherche a pour consequence et exigenced’avoir des professionnels experimentes et de mieux en mieux formes. Dans ce cadre, les paramedicaux sont de plus en plus impliques soit comme acteur accompagnant un projet de recherche, soit comme responsable/coordonnateur de recherche dans son champ d’expertise. La realisation d’ activites de recherche est une veritable opportunite de developpement professionnel continu. Il convient dansce cadre de renforcer la professionnalisation des paramedicaux et des metiers support de le recherche clinique, de promouvoir le role des paramedicaux et des metiers supportde la recherchedans lecadredu statutd’enseignant-chercheur et d’obtenir a terme une reconnaissance statutaire des paramedicaux et des metiers support par les tutelles.

Resume Objectifs Plusieurs indicateurs ont mis en evidence une performance francaise insuffisante dans la conduite d’essais cliniques, en partie liee a une formation des investigateurs et une organisation des sites insuffisantes et heterogenes. Un groupe multidisciplinaire a construit une formation de futurs formateurs a l’investigation clinique. Nous decrivons ici le referentiel elabore par le groupe sur l’organisation des sites investigateurs. Resultats Le groupe de travail incluait des personnes impliquees dans la recherche clinique d’origine academique, industrielle, autorite de sante, liberale, ou consultants independants. Des methodes et outils permettant une bonne organisation du site investigateur ont ete developpes. Conclusion Les outils proposes sont axes sur la connaissance par les investigateurs de leurs responsabilites, de leur environnement a l’hopital ou en ville, de l’analyse de la faisabilite, de methodes actives de recrutement des patients. Ils devraient permettre une meilleure organisation des sites investigateurs, pour de meilleures performances dans la conduite des etudes cliniques.

International audience; Osteoarticular iatrogenic infections may be serious and justify suitable and optimised preventive measures depending on each risk, as much in terms of mortality as of morbidity. Its appreciation has been the subject of more and more studies, which allow the importance of the problem to be better evaluated. The level of iatrogenic infections after arthroscopy is evaluated at 1 to 5‰ on a recent series of knee operations, but they may be much higher for the elbow [1] and [2]. In practice, this examination is no longer used for diagnosis as it was 10 years ago, the progress in imagery means this invasive act is no longer necessary...

The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE). While recognising the importance of compliance with this Directive, which is not optimal in some member states of the European Union, it would be constructive to simplify further and harmonise its application in every country. Without necessarily resorting to a revision, some of the Directive's dispositions could be improved, such as the definition of "investigational medicinal products" (IMP) and what should be considered as "substantial amendements", as well as harmonising and improving the way in which Ethics Committees are run, either on a European Commission level, or by relying more on the European Network of Research Ethics Committees (EUREC) which already exists in several European member states. Other points in the Directive do require revision, especially those relating to: the definition of the respective roles of Ethics Committees and Competent Authorities, the simplification of safety information to Ethics Committees (giving them access to the Eudravigilance database for adverse reactions occurring during clinical trials and providing them with only new safety issues or with a summary of the Annual Safety Report), the possibility of one single European authorisation for the trial, centralised and/or decentralised, when the trial is multinational. The recommended changes could be made within the scope of a European Regulation, avoiding the need to transpose it at a later date into each country's regulations, which is a source of possible lack of harmonisation. More specifically, for trials with institutional sponsors and/or investigator driven trials such as "drug therapy strategy trials", modulating restrictions according to the "risk added by the research" would enable the trial's organisation to be simplified regarding monitoring, adverse reactions reporting and study drugs labelling.

Resume L’objet de cette Table Ronde etait de proposer des recommandations en vue d’une prochaine revision de la Directive communautaire portant sur les essais cliniques de medicaments (2001/20/CE). Tout en reconnaissant l’importance de faire respecter l’application de la Directive, application qui apparait insuffisante dans certains Etats-membres de l’Union Europeenne, il serait utile de la simplifier davantage et d’harmoniser son application dans tous les pays. Sans recourir necessairement a une revision, certaines dispositions de la Directive pourraient etre ameliorees : meilleure definition des « medicaments experimentaux » et de ce qui doit etre considere comme « modifications substantielles » ou amelioration du fonctionnement des Comites d’Ethique (CE) au niveau de la Commission Europeenne en s’appuyant davantage sur l’ European Network of Research Ethics Committees (EUREC), reseau des CE existant deja dans plusieurs pays europeens. D’autres points de la Directive necessiteraient une revision, notamment ceux portant sur: - La definition des roles respectifs des CE et des Autorites Competentes. - La simplification de l’information de pharmacovigilance a relayer aux CE (leur donner acces a la base de donnees Eudravigilance sur les effets indesirables survenant en cours d’essai et ne leur envoyer que les faits nouveaux ou un resume du Rapport Annuel de Securite). - La possibilite d’une autorisation communautaire de l’essai, centralisee et/ou decentralisee lorsque l’essai est multinational. Les changements recommandes pourraient se faire dans le cadre d’un Reglement Europeen, ce qui permettrait d’eviter le besoin d’une transposition ulterieure dans la reglementation de chaque pays, source de dysharmonies potentielles. Plus specifiquement pour des essais de promotion institutionnelle de type « strategie therapeutique medicament », la modulation des contraintes en fonction du «risque ajoute par la recherche » permettrait de simplifier l’organisation de l’essai concernant notamment le monitoring, la gestion des effets indesirables et l’etiquetage des medicaments.

The working group focused on defining exploratory trials on medicinal products and developing recommendations for their implementation in France (notably concerning non-clinical requirements, the pharmaceutical quality of the investigational medical product and the conditions under which this type of clinical trial may be performed).To this end, the working group took account of existing guidelines (notably those in the USA and Belgium) and a draft revision of the ICH M3 guideline.Exploratory trials are clinical trials performed early in Phase I, prior to dose escalation and safety and tolerability trials. These trials are de facto first-in-man studies but lack a therapeutic or diagnostic goal and do not seek to establish the maximum tolerated dose (MTD). The objective is to answer precise questions which condition the continuation or suspension of the drug's development program. Exploratory trials include a small number of patients or healthy subjects and expose them (over a short period of time) to a low dose of an investigational medicinal product.The draft revision of M3 describes five approaches (two involving microdoses and three with pharmacological doses).The group's main recommendations can be summarized as follows:An exploratory trial may be performed when it is (i) justified, (ii) useful for product development and (iii) consistent with prerequisites. The pharmaceutical dossier should take account of the low quantity of product available, the short period of product administration and the low doses used. Good Manufacturing Practices can be adapted accordingly. The non-clinical dossier should also be adapted to suit the development phase and particular features of product use. In this respect, the group has commented on the recommendations in the draft revision of M3. The protocol must be designed to provide answers to a set of specific, pertinent questions concerning this administration phase - particularly on choice of the initial dose, the size of the dose escalation and the rules for subject withdrawal and trial suspension. In general, so-called "vulnerable" populations should not be involved in this type of trial, apart from duly justified exceptions. The group considered that approaches 3 to 5 should only apply to a medicinal product intended for treatment of a severe or rare disease or a condition with significant unmet medical needs. Pre-filing at the Afssaps (the French Agency for Healthcare Product Safety) is recommended, notably for approaches using pharmacological doses.

Resume L’objectif general de l’etude etait d’identifier les mesures devant permettre d’ameliorer la performance de la recherche clinique en France. Methode Grâce a la discussion entre les membres de la table-ronde (composee de medecins investigateurs ; responsables hospitaliers ; representants de promoteurs industriels ; medecins generalistes...), nous avons passe en revue les difficultes que rencontrent la recherche clinique francaise aujourd’hui. Resultats Nous avons identifie quatre champs d’action : 1) la disponibilite des ressources necessaires a la conduite des protocoles de recherche (disponibilite en quantite et en temps, dans les delais les plus brefs) ; 2) la faisabilite, celle de l’essai dans le design de son protocole, celle du recrutement qui depend a la fois du centre/equipe/reseau investigateur et des patients et de l’image qu’ils ont de l’experimentation biomedicale ; 3) la qualification et la motivation des individualites et des metiers associes qui composent l’equipe conduisant les protocoles de recherche ; 4) la fluidite et l’efficacite de l’organisation administrative pour des temps preparatoires au demarrage des essais les plus reduits au profit du temps de realisation de l’essai. Conclusion Cette etude, qui n’a pas la pretention a l’exhaustivite, a montre l’ampleur des efforts pour ameliorer l’organisation francaise d’essais cliniques.

The general objective of this study was to proceed an inventory of measures which could help to improve the efficiency of clinical research in France. Method Thanks to the discussion between the members of the round-table conference (composed of medical doctors (MD)/investigators; hospital managers; representatives of industrial promoters; general practitioners...), we have looked over the difficulties that meets clinical research in France nowadays. Results We identified four fields of action: 1) availibility of resources for carrying out the trials in time and in quality; 2) feasability of the clinical trials, in their design and for the recruitment which depends on both of the investigation centers and patients (what is the image of human testing in the society?); 3) skills and motivation of all the elements of staffs in charge of clinical trials (MD; nurses; and the new jobs in medical research); 4) promptness and efficiency of the administrative organisation for a fast starting up of the trials. Conclusion This study, which doesn’t pretend to sufficiency, shows the gap of improvement for French clinical trials organisation.

The "GIP CeNGEPS" (national center of industrial clinical trials' management), a new corporate body, relates the major French actors in clinical trials activity, belonging to public service or commercial sector. CeNGEPS is devoted to improving the French organisation of clinical trials with four headings: Economic with a strong common will of shaking up the organisation of clinical trials in France; Political with a decision taken to the highest level; Juridical with the choice of an unusual legal form to act; Methodological with the efforts to associate the most numerous operators (investigators; local managers...).

The initiation of Horizon 2020--the European Union's 8th Framework Programme for Research and Innovation, allotted a budget of 79 billion euros--provides an opportunity to review France's participation in previous Framework Programmes. Indeed, French participation does not match either its scientific importance or its financial investment. While France contributed 16.5 to 17% of the EU's 7th Framework Programme research budget, its return through the funding of coordinated projects in which French teams are participating stands at around 12.5 to 13%, a shortfall of 600 million euros. Although the situation depends on the type of activity, French participation in clinical research appears to be smaller than that of its neighbours, with fewer responses to European calls for proposals. While France has many assets, which include the assured funding of clinical research, structured thematic networks and the initiation of major national programmes, it suffers from the dilution of resources due to France's regional development policy, the lack of multidisciplinarity and the ignorance of both the medical and scientific community and the institutions to which they belong as to how Horizon 2020 actually works. We propose three types of strategy to encourage proposals for coordinated clinical research projects or projects involving French teams, and to help in the drawing up of applications: Broaden the vision of our children, students and colleagues, helping them to adapt to the globalisation of knowledge throughout their educational and professional lives. Recognise the value of European actions to influence the European landscape and change mentalities. Help and support project initiators by pooling skills within a limited number of expert centres designed to assist them in their funding application. • Broaden the vision of our children, students and colleagues, helping them to adapt to the globalisation of knowledge throughout their educational and professional lives. • Recognise the value of European actions to influence the European landscape and change mentalities. • Help and support project initiators by pooling skills within a limited number of expert centres designed to assist them in their funding application.

Clinical research is of major importance to today’s society, as scientific evidence is increasingly demanded as a basis for progress, whether this involves developing new health care products, improving clinical practice and care protocols or progress in prevention. Clinical research therefore requires professionals who are both experienced and increasingly well trained. Against this background, allied health professionals are becoming involved more and more, both as team members supporting clinical research projects and as managers or coordinators of projects in their own field. Clinical research activities provide an ideal opportunity for continuing professional development. All of this means that the professional skills of the allied health professions and clinical research support professions must be enhanced, their role promoted in the context of lecturer status and in the longer term, their status recognised by the supervisory authorities.

Several surveys have shown a declining performance of French investigators in conducting clinical trials. This is partly due to insufficient and heterogeneous investigator training and site organisation. A multidisciplinary group was set up to propose solutions. We describe the tools developed to improve study site organisation.This working group was made up of clinical research experts from academia, industry, drug regulatory authorities, general practice, and consulting. Methods and tools were developed to improve site organisation.The proposed tools mainly focus on increasing investigators' awareness of their responsibilities, their research environment, the importance of a thorough feasibility analysis, and the implementation of active patient recruitment strategies. These tools should be able to improve site organisation and performances in conducting clinical trials.

The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical studies). The analysis was focused on the data and on the critical stages presenting critical quality problems, for which the current guidelines are insufficiently detailed, unsuitable and/or poorly applied. Finally, recommendations have been proposed, mainly focused on the origin of the data and its transcription.

The "GIP CeNGEPS" (national center of industrial clinical trials' management), a new corporate body, relates the major French actors in clinical trials activity, belonging to public service or commercial sector. CeNGEPS is devoted to improving the French organisation of clinical trials with four headings: Economic with a strong common will of shaking up the organisation of clinical trials in France; Political with a decision taken to the highest level; Juridical with the choice of an unusual legal form to act; Methodological with the efforts to associate the most numerous operators (investigators; local managers...).