[Development of an artificial intelligence system to improve cancer clinical trial eligibility screening]. / Développement d'une solution d'intelligence artificielle pour améliorer le screening en recherche clinique.

INTRODUCTION: The recruitment step of all clinical trials is time consuming, harsh and generate extra costs. Artificial intelligence tools could improve recruitment in order to shorten inclusion phase. The objective was to assess the performance of an artificial intelligence driven tool (text mining, machine learning, classification…) for the screening and detection of patients, potentially eligible for recruitment in one of the clinical trials open at the "Institut de Cancérologie de Lorraine". METHODS: Computerized clinical data during the first medical consultation among patients managed in an anticancer center over the 2019-2023 period were used to study the performances of an artificial intelligence tool (SAS® Viya). Recall, precision and F1-score were used to determine the artificial intelligence algorithm effectiveness. Time saved on screening was determined by the difference between the time taken using the artificial intelligence-assisted method and that taken using the standard method in clinical trial participant screening. RESULTS: Out of 9876 patients included in the study, the artificial intelligence algorithm obtained the following scores: precision of 96 %, recall of 94 % and a 0.95 F1-score to detect patients with breast cancer (n=2039) and potentially eligible for inclusion in a clinical trial. The screening of 258 potentially eligible patient's files took 20s per file vs. 5min and 6s with standard method. DISCUSSION: This study suggests that artificial intelligence could yield sizable improvements over standard practices in several aspects of the patient screening process, as well as in approaches to feasibility, site selection, and trial selection.

[Clinical research in general hospital centres in France, strengths and weaknesses]. / Recherche clinique au sein des centres hospitaliers généraux en France, forces et faiblesses.

Clinical research is an essential activity in cancer care. Both for patients, who can gain access to innovative therapies, and for practitioners, who can maintain their skills and stay at the forefront of new treatment approaches. First developed in university hospitals, clinical research is now established in general hospitals and private health institutions. The number of patient inclusions in clinical trials has doubled over the last ten years, thus reflecting the dynamism of it. Strengths and weaknesses, opportunities and threats concerning clinical research, and more specifically clinical research in general hospitals, are exposed in this article.

[Clinical research in private sector: Which strategic analysis?] / Recherche clinique en structure libérale : quelle analyse stratégique ?

Clinical research in private practice has significantly increased in recent years and has become crucial for the attractiveness of centres both for patients who can access innovative treatments and molecules and for participating physicians. The responsiveness, the size and reduced number of interlocutors, flexibility, and decision-making autonomy of private practitioners are strengths in the strategic analysis of clinical research in the private sector. However, the varied medical activity allowing for broader recruitment, location of practice, and administrative time related leadership roles can become weakness in terms of quality and time dedicated to this research activity, which still relies heavily on strong individual involvement. Collaborations, which develop when clinical research in private centres is dynamic, are sources of opportunities, growth, and progress, allowing participation in various ambitious projects that can benefit patients in these facilities. Recent administrative and legislative complexities for trial integration and competition with academic structures can threaten this important clinical research activity for private practices, requiring reflection on its valorisation and promotion to ensure its sustainability.

[Chronic obstructive pulmonary disease and music therapy]. / Bronchopneumopathie chronique obstructive et musicothérapie.

Chronic obstructive pulmonary disease with disabling co-morbidities can benefit from music therapy devices that are effective on anxiety, dyspnea, depression and quality of life. This complementary support therapy is easy to implement, in hospital or at home, and allows the patient to take ownership of this self-care.

[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.

[ISO 9001: 2015 certification of all research activities of a university hospital center]. / Certification ISO 9001 : 2015 de l'ensemble des activités de recherche d'un centre hospitalier universitaire.

INTRODUCTION: In France, the number of hospitals involved in clinical research and committed to a quality approach is increasing. The objective of such approaches is to ensure the safety of patients involved in research projects by improving quality. OBJECTIVE: The University Hospital of Amiens has chosen to certify all its clinical research activities in the same scope according to the ISO 9001: 2015 standard. METHODS: Action planning has been established and a head of quality management has been appointed to oversee this process. RESULTS: The activities in the five departments of our university hospital jointly certified in December 2019, are: activities related to internal and external sponsors, as well as methodology and monitoring of clinical research projects conducted in the Clinical Research and Innovation Department (CRID); help with clinical research investigations in the Clinical Research Center (CRC); management of the pathway of therapeutic units used in clinical research (excluding the manufacture of drugs) in the Clinical Trials Unit (CTU) of the Hospital Pharmacy; the conservation and provision of biological resources (tissues and fluids) for cancer research in the Tumor bank of Picardy; the collection, reception, preparation, quality control, conservation and provision of biological resources for research purposes. These activities fall within the framework of legal and regulatory activities and the provision of secure storage in the Biological Resources Center already ISO 9001 certified since 2004 and NF S96-900: 2011 certified since 2009. CONCLUSIONS: The choice of a common quality approach has brought together more than 70 persons from 5 departments involved in clinical research projects within a single certificate with the aim of continuous improvement.

[Requests for genetic characteristics analysis by sequencing in clinical research: Legal and ethical considerations]. / Les demandes d'analyses des caractéristiques génétiques par séquençage dans les recherches cliniques : considérations juridiques et éthiques.

More and more practitioners are being led to propose to their patients an analysis of their genetic characteristics (structural or functional genomics) either to confirm a diagnosis or to adapt a treatment (personalized medicine). Patients treated in hospitals are also offered analyses of their genetic characteristics either because they have not objected to their biological samples taken during care being used for research, or because they are included in a clinical study. The revised bioethics laws for application on 1/1/2021 provide a complete and clear framework for practices concerning genetics. However, most patients or healthy volunteers who have agreed (or not objected) to genetic testing are not aware of the potential consequences for them and their families. This is mostly due to a lack of information (inclusion of a sample without seeking express consent) or partial information due to either a lack of training of the prescriber himself or, in the context of clinical trials, an inadequate information leaflet. In order to help prescribers and evaluators of clinical trial applications to propose fair and clear information and consent letters to patients and thus ensure patient protection, we have produced an exegesis of the legal and ethical elements on which to base a proposal for genetic characteristics analysis. We include examples of requests for analysis of genetic characteristics, specifying the cases in which the research is authorized or not and mentioning the corresponding legal texts. We have generated here a useful pedagogical tool for all prescribers, researchers or simply French citizens.

Les grands enjeux actuels de la recherche infirmière / Current issues in nursing research

La profession infirmière est un exemple où la recherche a fait évoluer conjointement, la santé de la population et les pratiques professionnelles dans le monde. "Cette évolution a favorisé l’émergence et l’affirmation d’une culture scientifique au sein du groupe professionnel tout entier". Elle a ainsi fait progresser la pratique fondée sur les preuves et la qualité des soins, tout en prenant en compte l'expertise du patient. Cette démarche demande des compétences spécifiques que les cursus de formations initiales et continues doivent intégrer [leer más en el PDF].(AU)

[Clinical research in the home as a tool for improving practice]. / La recherche clinique au domicile comme outil d'amélioration des pratiques.

The quality of life in hospital at home has been very little described. In the "Feel'HAD" study, 488 patients completed an EQ-5D-3L questionnaire during a nursing visit. Neurological and geriatric pathologies were found to be the most degraded, even if there were strong disparities within the different types of conditions. This work has shown that beyond technical care, some people need more support, psychological care, comfort or social support. It led to concrete improvements in our practices and demonstrated that large-scale research is possible in the home.

[Clinical research in radiotherapy oncology in private sector: A reality with a possible future?] / Recherche clinique en oncologie radiothérapie dans le secteur libéral : une réalité avec un avenir possible ?

Clinical research is one of the activities of medical practice, particularly in oncology including radiotherapy. It was developed in the public sector and then in the liberal sector, in compliance with regulatory institutions, resulting in a doubling of inclusions over the last decade. Setting up and developing clinical research in the liberal sector are major axes in terms of interests: improving the proposition of care, access to innovation, to keep patients, intellectual stimulation, encouraging recruitment, activity of scientific publications, financial valorisation, quality of visibility… An inventory on French national territory via the national union of iadiotherapists oncologists (SNRO) and the club of liberal oncologists (Colib) is reported in this article, as well as examples of structuring and organization.

[Clinical trials in Radiation Oncology: Methodologic approach]. / Essais cliniques en Oncologie Radiothérapie : réflexion méthodologique.

In the context of the clinical development of radiation oncology, the specificities of curative treatments and the necessary follow-ups for the acute and late tolerance evaluation require rigourous and up-dated methodological approaches given the limited feasibility of some studies to demonstrate their effectiveness. Indeed, the diversity of treatments in terms of delivery, type of radiation and multiple technologies render difficult the medical assessment. Although the randomized controlled trial is the gold standard for demonstrating the causal link of the treatment effect size, a state of the art of current limits is presented and proposals for new methodological approaches are discussed as alternative or complementary possibilities. Co-primary endpoints or pragmatic composite endpoints are to be used with adequate statistical analyses, the use of Bayesian methods, the re-use of observational data for the external control arms identification and the development of Real World Data registers is to be preferred to respond to this colossal challenge.

[Goals, motivations, and difficulties of young oncology residents]. / Objectifs, motivations et difficultés des internes en phase socle en oncologie.

INTRODUCTION: The Association for education and research of interns in oncology (AERIO) conducted a national survey of the 2020-year oncology residents promotion in the "phase socle". The objective was to collect and analyze their motivations, as well as the objectives and limitations in the life and career of the residents during this first year of residency. METHODS: A questionnaire included 45 closed questions divided into 6 sections describing: the demographic characteristics of the population, the commitment of the students' and their clinical and academic expectations in the, their training, their life and career objectives, and their commitment in associative life. RESULTS: Seventy-eight of 119 residents participated (66%), of which 68 (87.2%) completed the questionnaire entirely. The population was predominantly women (60%) with a median age of 24 years. The choice between medical or radiation oncology was mostly undefined (87%) and 15% of the residents considered to change their medical specialty. The average hospital work time reported was predominantly between 45 and 65hours per week (83%). Sixty-nine percent were primarily interested in clinical research. One out of two residents (52%) did not have access to their half-day of training per week. DISCUSSION: This national survey made possible to analyze the perception of oncology young residents, as well as their career aspirations and their relationship to research.

[The roles of patients in healthcare provision, training and research: A French perspective]. / Rôles des patients dans le système de santé, la formation et la recherche en santé : une perspective française.

In 2002, patients were transformed into users of the French health system. As this opinion piece demonstrates, in 2021 they may at least potentially participate more actively than before. They can convey their knowledge of a disease and its treatments, and voluntarily share their experience. They can intervene in user representation and therapeutic patient education, the objective being to increase the autonomy of one and all, patients and public, in the training of professionals, clinical research and evolution of the health system. The rationale for the involvement of patients and their roles in provision of care, training and clinical research are analyzed from a French perspective. The obstacles to overcome and improvements to be achieved are reviewed, the objective being to promote enhanced health democracy through increased patient engagement. In 2021, however, the role of patients in the design and implementation of therapeutic patient education (TPE) and in the development of medical studies curricula remains limited if not restricted; this is due not only to a lack of information, but also to the resistance of health professionals and universities. Patients could and should assume a major role, fostering evolution toward a more just and effective health care system.

[An example of Clinical Investigations Center reorganization during the COVID-19 pandemic French national lockdown]. / Un exemple de réorganisation dans le fonctionnement d'un Centre d'investigations cliniques en période de confinement national suite à la pandémie COVID-19.

BACKGROUND: The Clinical Investigations Center of Saint-Louis Hospital (CIC-1427) is a structure dedicated to clinical trials and mainly early phase trials (first-in-man administration, phase 1 and 2). These trials are conducted in a French Regional Health Agency (ARS) authorized structure. In March 2020, faced to the global COVID-19 pandemic and the French national lockdown measures, the CIC-1427 had to rapidly adapt its operating procedures to ensure the safety of both patients and staff. STUDY OBJECTIVE: Ensuring optimal management of patients included in early phase clinical trials, while respecting the good clinical and professional practices (GCP/GPP) of the CICs protocol sponsors' requirements, patients' safety and clinical research multidisciplinary staff safety (nurses, caregivers' assistants (AS), clinical research assistants (CRA), clinical trial coordinators (CTC), project leaders, health executive and investigating physicians), in the context of the health crisis related to COVID-19. METHODS AND RESULTS: Due to their activity, requiring on-site presence, each staff member of the CIC-1427 clinical research team had to adapt their daily activity to the constraints of the health crisis. New specific procedures were quickly developed to deal with the pandemic. Most of the on-site medical visits were replaced by virtual consults with biological assessments in the local laboratories. "Remote monitoring" replaced on-site monitoring visits. Treatments were sent to each patient's home via couriers after agreement of the CPPs of each protocol (Committee for the Protection of Persons). The essential visits were maintained on site thanks to the unfailing involvement of our clinical care team, with implementation of a specific sanitary protocol. CONCLUSION: The involvement of our entire multidisciplinary research team ensured that each patient was able to benefit from a personalized follow-up and to continue the treatment on-trial. The newly introduced procedures also allowed collection of a maximum of safety and efficacy data for clinical trial sponsors while complying with good regulatory practices. This set of procedures developed during the first epidemic wave, fundamentally helped setting the frame for a better coping during the subsequent pandemic waves.

O (f)ato clínico como ferramenta metodológica para a pesquisa clínica em psicanálise / The clinical (f)act as a methodological tool for clinical research in psychoanalysis / Le (f)ait clinique comme outil méthodologique de recherche clinique en psychanalyse

Este artigo tem origem no amplo campo da relação da psicanálise com a universidade. A partir do reconhecimento de que essa relação é marcada por impasses, mas também por potencialidades, restringimos o foco da nossa pesquisa às possibilidades de pesquisa clínica em psicanálise. Após trabalhar com textos de Freud e Lacan, fizemos um levantamento de algumas metodologias utilizadas para o registro clínico em psicanálise. Assim chegamos ao nosso enfoque na investigação, o fato clínico. Decidimos delimitá-la por sua potencialidade teórica e de formação na psicanálise. Chama a atenção a relativa escassez de publicações a esse respeito. Finalmente destacamos o modo de fazer operar a clínica com a teoria. Sublinhamos os conceitos de ato psicanalítico, ato teórico e ficção, como operadores a partir do real que é a clínica, como suportes privilegiados para forjar os conceitos. A partir da clínica, podemos escrever fazendo contorno no real, construir um caso e propor um fato clínico. Consideramos que são essas ferramentas teóricas que permitem que operemos no campo abstrato, trabalhando hipóteses para tocar o que é de certa forma inacessível na clínica e assim podermos colher os efeitos da psicanálise, viabilizando por essa via a pesquisa no campo.

This article originates in the broad field of the relationship of psychoanalysis with the university. From the recognition that this relationship is marked by impasses, but also by potentialities, we narrow the focus of our research to the possibilities of clinical research in psychoanalysis. After working with texts by Freud and Lacan, we surveyed some methodologies used for the clinical record in psychoanalysis. Thus we come to our focus on research, the clinical fact. We decided to delimit it by its theoretical potential and formation in psychoanalysis. The relative scarcity of publications in this regard draws attention. Finally we highlight how to operate the clinic with theory. We underline how the concepts of psychoanalytic act, theoretical act and fiction, as operators from the real derived from the clinic, as privileged supports to forge the concepts. From the clinic, we can write around the real, build a case and propose a clinical fact. We consider that it is these theoretical tools that allow us to operate in the abstract field, working hypotheses to touch what is somewhat inaccessible in the clinic and thus we can reap the effects of psychoanalysis, thereby enabling research in the field.

Cet article trouve son origine dans le vaste champ de la relation de la psychanalyse avec l'université. Partant du constat que cette relation est marquée par des impasses, mais aussi par des potentialités, nous restreignons le champ de nos recherches aux possibilités de la recherche clinique en psychanalyse. Après avoir travaillé avec des textes de Freud et Lacan, nous avons étudié quelques méthodologies utilisées pour le dossier clinique en psychanalyse. Nous arrivons ainsi à notre approche à la recherche sur le fait clinique. Nous avons décidé de le délimiter par son potentiel théorique et de la formation en psychanalyse. La rareté relative des publications à cet égard attire l'attention. Enfin, nous soulignons comment faire fonctionner la clinique avec la théorie. Nous soulignons les concepts d'acte psychanalytique et d'acte théorique et la fiction, en tant qu'opérateurs du réel propre de la clinique, comme supports privilégiés pour forger les concepts. Depuis la clinique, nous pouvons écrire autour du réel, construire un cas et proposer un fait clinique. Nous considérons que ce sont ces outils théoriques qui nous permettent d'opérer dans le domaine abstrait, travaillant des hypothèses pour toucher ce qui est en quelque sorte inaccessible en clinique et ainsi nous pouvons récolter les effets de la psychanalyse, permettant ainsi la recherche dans le domaine.

[Initiation in nurse training institutes]. / L'initiation à la recherche en Ifsi.

The 2009 reference frame gave research a place of honour. Initiation in research is a training activity for which nursing students are personally supported by a trainer. The particular profiles of these students, the diversity of their subject and the experience of the trainer are all elements that are likely to vary the way in which the support is implemented.

Proton therapy and the European Particle Therapy Network: The past, present and future.

Proton therapy is delivered to selected cancer patients presenting with rare tumours, for which a dose escalation paradigm and/or a reduced dose-bath to the organs at risk is pursued. It is a costly treatment with an additional cost factor of 2-3 when compared to photon radiotherapy. Notwithstanding the 180'000 patients treated with protons, scars robust clinical evidence is available to justify the administration of this treatment modality. The European Particle Therapy Network (EPTN) was created in 2015 to answer the critical European needs for cooperation among protons and carbon ions centres in the framework of clinical research networks. EPTN with other European groups will launch a number of prospective clinical trials that could be practice changing if positive. Alternative way to generate clinical data could be provided by alternative methodologies, such as the Dutch model-based approach, or could be provided by European infrastructure projects.