"Artificial intelligence": Which services, which applications, which results and which development today in clinical research? Which impact on the quality of care? Which recommendations?

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.

How to strengthen the presence of patients in health technology assessments conducted by the health authorities.

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.

What specifications for a centre or network of excellence in clinical research?

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).

What strategy should France implement for H2020?

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.

[Organising an investigation site: a national training reference document]. / Organiser un site investigateur : un référentiel national de formation pédagogique.

OBJECTIVE: 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. RESULTS: 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. CONCLUSIONS: 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.

Promoting the place of the allied health professions in clinical research.

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 healthcare 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.

How can the quality of medical data in pharmacovigilance, pharmacoepidemiology and clinical studies be guaranteed?

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.

[OLGA, digital platform for the management of national health research networks: An effective model for complex organizations?] / OLGA, plateforme numérique d'aide au pilotage de réseaux nationaux de recherche en santé : un modèle pour les organisations complexes ?

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.

Platform trials.

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.

Outpatient healthcare and clinical trials in the care pathway: Organisational and regulatory aspects and tools.

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.

How to improve clinical research performances in France?

UNLABELLED: 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) availability of resources for carrying out the trials in time and in quality; 2) feasibility 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.

[GIP CeNGEPS, an agreement of clinical research operators to reinforce clinical trials' organisation in France]. / GIP CeNGEPS, un collectif des opérateurs de recherche clinique pour une organisation des essais cliniques industriels plus performante.

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...).