Spontaneous reporting is the reference method for collecting data on adverse drug reactions (ADRs). However, it remains insufficient. Text search in the electronic medical record has opened up a new way of collecting ADRs. However, these methods have certain limitations. Data warehouses constitute a rich digital environment bringing together all the informations in an electronic medical record. The Clinical Data Centre (CDC) at Brest University Hospital has developed a pharmacovigilance tool, the HOPIPRAC interface, which provides autonomy in querying the entire hospital database to detect cases of suspected ADRs from computerised patient records.

This study has two main objectives: 1/ to validate the International Classification of Diseases, 10th revision (ICD-10) diagnostic codes of skin ulcer in one French hospital using medical charts; 2/ to validate an out-hospital algorithm against ICD-10 codes using a healthcare database.

The safety profile of a rechallenge with BRAF inhibitors (BRAFi) or a combination of BRAF and MEK inhibitors (MEKi) following an adverse drug reaction (ADR) remains largely unexplored.

Apalutamide is an oral androgen receptor pathway inhibitor used to treat non-metastatic castration-resistant prostate cancer at high risk of developing metastases. Skin toxicity of apalutamide is documented, including a few cases of lichenoid drug eruptions (LDE). The objective of our study is to qualitatively and quantitatively describe LDE associated with apalutamide using data from the French Pharmacovigilance Database (FPVD) and Vigibase.

Infusion-related reactions to immunoglobulins are well documented. The objective of this study was to characterize these reactions using real-world data to provide clinically relevant information.

A supply shortage of dronabinol occurred between December 2023 and February 2024, forcing chronic pain patients to discontinue this treatment. We assessed the impact of this shortage on patients in our hospital.

During coronavirus disease 2019 (COVID-19), the incidence rate of adverse drug reactions (ADRs) in hospitalized patients seemed higher than before the pandemic. Severe inflammation triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was cited as an explanation. We aimed to determine whether COVID-19 infection was associated with a higher risk of ADRs compared to other infectious diseases.

Metformin-associated lactic acidosis (MALA) is a rare but serious adverse drug reaction (ADR). The aim of the study was to identify clinical situations associated with the onset of MALA in patients hospitalised in the Nord Pas de Calais regional intensive care units (ICUs), and to assess its preventability.

In line with the spirit of the Giens workshops, this article reports on the recommended evolution of the Ethics Committees (CPPs) and the Committees for Research Ethics (CER) in France. These committees play a crucial role in the ethical evaluation of clinical research projects, a process that has become more complex, particularly in view of recent legislative, regulatory and methodological developments. This reflection highlights the current challenges faced by the CPPs, including the increasing workload, the complexity of the issues to be addressed and the need for better use of their resources. To address this, several recommendations are proposed. These include improving support to sponsors prior to submission, simplifying administrative tasks for CPP members and improving IT tools. The article also highlights the need for continuous evaluation of the activities of the CPPs to contribute to the quality and consistency of their opinions, as well as the importance of making this activity more attractive to qualified professionals, by offering them adequate compensation and professional recognition. For the benefit of all involved in health research, there is a strong desire to develop a single document management system accessible to all and inclusive of relevant information and document templates. Regarding the CERs, which currently operate without a legal framework, the proposition is that their development should take place under conditions of compliance with essential principles of collegiality, transparency and appropriate management of conflict of interest. Finally, it appeared necessary that the National Commission for Research Involving the Human Person (CNRIPH) be given adequate resources to carry out its tasks effectively, including the coordination of the CPPs and the development of appropriate training programs for their members. These recommendations aim to improve the operating conditions of the CPPs and CERs, ensuring the ethics of the research undertaken, as well as the quality of their results.

4P medicine (personalized, preventive, predictive, and participatory) is experiencing a remarkable rise, and pharmacogenetics is an essential part of it. However, several obstacles are hindering its deployment. This round table brought together a group of experts to take stock of the situation, reflecting on ways to facilitate the prescription of these tests and the dissemination of the results on a national scale. The experts looked at the methods of prescribing and communicating pharmacogenetic data in the current situation as well as in the coming years, with the arrival of artificial intelligence software. The questions relating to the reimbursement of tests - as topical as ever - were also discussed, as this is a way to allow all patients to access these tests. Numerous recommendations have been formulated on these various points, aimed at facilitating prescription management for healthcare professionals, and ensuring the retention and use of the results throughout the patient's life. Finally, better patient information was recommended, as well as strengthening the involvement of healthcare professionals and industry stakeholders in this process, with insistence on the necessary training and commitment to ensure its success.

Over the past decade, new in vitro biological models have emerged which can reproduce certain characteristics of human physiology and pathologies. From organoids to organs-on-chips, these new technologies are currently revolutionizing the entire chain of research and development in pharmacology. All stakeholders are thus involved, from academic laboratories to pharmaceutical companies, start-ups, and assessment agencies. By providing better predictability, these new human biomimetic models also help address societal and ethical challenges regarding the place and use of animals in biomedical research. In this context, participants at the Ateliers de Giens (Giens Workshops) roundtable wished to examine the issues related to these new technologies with their various expertise and, given the stakes involved in the medicine and pharmacology of the future, formulate several recommendations aimed at strengthening the national structuring of the academic and industrial sector, therefore accelerating the development and validation of these new models.

France has been engaged in a legal and organisational transition for many years. It has had to adapt its national framework to the legal requirements of personal data protection, European ambitions and international competition. From the Data Protection Act of 1978 to the Healthcare System Transformation Act of 2019, reforms have strengthened requirements in terms of personal data protection, while opening the way to innovative uses. Recent European regulations, such as the AI Act (2024) and the European Health Data Area (2024), aim to reinforce this dynamic, ensuring a secure, transparent and competitive framework for the sharing and use of health data. How can we ensure that the re-use of healthcare data is truly effective, while respecting the fundamental rights of citizens? How can we reconcile national and European ambitions with the technical and organisational realities of the healthcare system, in clinical and research teams, and as close as possible to patients and users in our territories? These questions are essential, because access to and use of health data are seen as major levers for improving the quality of care, supporting innovation and boosting the competitiveness of the French healthcare system. The impact study on the 2019 reform stresses that the transformation of the healthcare system will have to be based on taking better account of the needs of patients and professionals by encouraging local initiatives. In this context, France faces a priority to establish greater coordination between the national and local levels, while preserving the trust of users. This precious trust is essential if we are to make the transition to achieving national and European objectives for the scientific and economic use of data.