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Objective : The aim of the study was to describe the patient journey, experience of living with the disease, impact on daily life, relationships with healthcare professionals, and needs and expectations of patients with metastatic breast cancer (MBC). Methods : A survey was conducted using self-completed questionnaire. The questionnaire was given to women with MBC diagnosed at least six months earlier and recruited by their respective specialist. Results : A total of 230 women with an average age of 59.2 years, cared for by 52 specialists took part in the survey. Overall, patients are well informed about their disease and 75% knew the type of cancer (hormone receptors and HER2 status). More than 60% felt they were listened to and well supported at the time of the diagnosis; however, half did not fully understand everything the physician said. 67% were able to meet a nurse. An information leaflet on the disease was given to 47% of participants; 19% received details of related associations. Patients had access to an average of 2.5 healthcare professionals for supportive care, primarily psychologists/psychotherapists (47%) and physiotherapists (30%). The adverse impact of treatments—mainly fatigue for 80% of patients—was significant in daily life in approximately half the cases and more common for women undergoing chemotherapy. In total, 41% and 42% of women reported seeking information about the disease and treatments, respectively, with their primary source being physicians. Conclusion : Women with MBC in France are on the whole satisfied with their management by healthcare professionals; however, the disease has a significant negative impact on patients’ daily life and a need for additional information has been observed.

Resume Le sujet de la table ronde etant initialement tres vaste, il avait ete convenu avec les participants de le recentrer sur les therapies cellulaires (TC) impliquant des cellules autologues utilisees dans des situations de reconstruction tissulaire, d’immunomodulation et de transduction. La TC autologue concerne aussi bien des pratiques tres innovantes que des produits utilises en routine depuis plusieurs annees. Le cadre reglementaire de la TC est maintenant finalise en France. Ce dernier met en exergue le fait qu’un produit de TC est intrinsequement lie a son procede de preparation. L’objectif de cette table ronde etait de definir les pre-requis indispensables a prendre en compte lors du developpement de therapies impliquant des preparations cellulaires ex vivo et ce, afin de s’assurer de la securite d’emploi de tels produits. Les differentes etapes du developpement d’un produit de therapie cellulaire (PTC) ont ete envisagees : (i) contraintes de production permettant de garantir la qualite du produit ; (ii) developpement non clinique : importance de modeles animaux pertinents pour demontrer la preuve du concept et affiner les specifications du PTC ; (iii) developpement clinique : specificite methodologique du developpement d’un PTC. Les problemes inherents a l’utilisation des produits therapeutiques annexes (PTA) au cours du developpement d’un PTC ont ete souleves. Des mesures ont ete envisagees pour qu’a terme l’approvisionnement et la qualite d’un PTA ne constituent pas des facteurs limitants pour le developpement de la TC en France. Enfin, une information des professionnels de sante et des industriels concernant la biovigilance s’est averee necessaire.

The topic of the round table being very broad, it was agreed with the participants that the discussion should be focused on autologous cell therapy (CT) used in tissue repair, immunomodulation or gene transduction. Autologous CT is actually comprised of both very innovative procedures as well as of products used in routine clinical practice. In France, the regulatory framework for CT has now been finalised, underlining the fact that a CT product (CTP) is intrinsically linked to the process used in its preparation. The objective of this round table was to define the essential prerequisites for the development of therapies involving ex vivo cell preparations and, more specifically, to address the issues associated with patient safety during the course of product development. The different stages of CTP development were considered: (i) requirements for CTP manufacturing in order to guarantee product quality; (ii) nonclinical development, and selection of appropriate animal models to provide the proof of the concept and support the definition of CTP specifications; and (iii) clinical development and methodological specificities of CTP development. The specific problems associated with the use of ancillary therapeutic products (ATPs) during the development of a CTP were discussed. Actions were proposed to ensure long-term supply of ATPs, which may be a significant bottleneck for the development of CT in France. Eventually, new regulatory provisions will come into force in the area of biovigilance, and it was deemed necessary for healthcare and industry professionals to be appropriately involved in the implementation phase.

Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: – there is no need for additional legal or regulatory constraints; – sponsors should be aware of and make use of direct public information on trials; – a ‘good practice charter’ on public communication about clinical trials should be developed; – all professionals should be involved in this communication platform; – communication in the patient’s immediate vicinity should be preferred (primary-care physician, local press); – clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; – genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; – media groups should receive at least some training in the fundamentals of clinical research.