France may have ceded Europe’s top spot for the sheer number of clinical trial starts to Spain in 2023, but it remains one of Europe’s most strategically valuable destinations for complex, high-science clinical research. In oncology and rare diseases clinical R&D especially, France punches well above its weight, supported by deep investigator expertise, highly specialised centres, and an unusually tight integration between basic research and clinical practice. With recent regulatory adjustments opening the door to new trial designs, including decentralised and adaptive approaches, France is positioning itself as a global reference for scientific rigour and high-value clinical data.
In the eyes of many international drug developers, the French market has evolved into an almost indispensable clinical trials destination. “Our in-country clinical research footprint has undergone dramatic expansion. Previously, we participated in approximately 50 percent of Novo Nordisk’s global clinical trials, but now we possess the infrastructure to support virtually all corporate studies, having established a dedicated 45-person clinical team which is directly employed rather than contracted through clinical research organisations,” expounds Etienne Tichit, general manager and corporate vice president at the Danish specialty biopharma. “This expansion should enable us to double the number of patients enrolled in our French clinical trials, from under 40,000 currently to over 80,000 by 2028,” he forecasts.
AstraZeneca, too has been steadily ramping up their investment in this area. “Our French affiliate now consistently ranks among the top three countries in Europe for research intensity, with over 150 ongoing clinical trials. While oncology remains a core strength, we have made notable progress in cardiovascular and respiratory research, quadrupling patient enrolment in these areas over the past two years,” discloses the Anglo-Swedish company’s president, Anne-Laure Dreno. “This reflects an exceptional and ever-strengthening scientific ecosystem benefiting from robust hospital networks, highly trained investigators, and well-informed patient populations,” she explains.
‘France has long been recognised for the excellence of its basic research, and our clinical infrastructure matches this standard, with institutions such as Gustave Roussy and Institut Curie capable of running Phase I, II, and III trials of exceptional quality. This generates robust data that is highly valued internationally,” posits the PSCC’s Benjamin Garel. “Another distinctive strength is our healthcare system, which offers equal access across the population. Unlike settings where clinical trials reach only a fraction of society, in France, data are drawn from diverse patient groups, making them broader, more representative, and therefore highly relevant for global development,” he perceives.
It is most definitely in the high complexity areas of oncology and rare disease trials that France’s competitive edge most comes to the fore, however. “Our country’s advantage resides in its remarkably sophisticated integration between basic research and clinical application, combined with our network capacity for rapid patient recruitment into clinical studies,” perceives Jean-Yves Blay, general director of the Centre Léon Bérard, a premier Lyon-based hospital dedicated wholly to cancer care and research. “While site activation can prove administratively demanding, once operational, our recruitment velocity and data quality are in a league of their own and companies generally come away convinced that the rigour, and commitment among our investigators makes the effort worthwhile,” he ventures, noting that nowadays the country accounts for over 15 percent of global cancer studies.
“Unlike say large-scale cardiovascular or neurological trials, oncology studies typically involve smaller patient groups but a considerably greater scientific complexity, which is why we consider it necessary to leverage the depth of expertise and precision of French investigators in this field,” agrees Corinne Blachier-Poisson, former general manager at Amgen, who mentions that her affiliate conducted 45 active clinical studies across the country last year, engaging more than 300 clinical centres and over 700 patients in the process.
Rethinking Trial Design
That is not to suggest that France can afford to be complacent. “France’s overall relative position for generalised trials has actually declined in recent years,” points out Nienke Feenstra, general manager at Takeda. “This is not because its science itself has weakened, but because rival markets have been busy pursuing proactive policies to simplify procedures and upgrade their frameworks. “In Spain, for example, GPs are now incentivised to refer patients, while the region of Catalonia, for example, has built a dynamic digital health environment with integrated data systems,” she adds.
Yet, according to Charles-Edouard Escurat, director general at the Agence de l’innovation en Santé (AIS), such numbers need to be viewed with perspective. “The decline in clinical trial activity is not unique to France; it reflects a broader trend affecting Europe and the United States, while Asia is rapidly expanding. After all, China’s share of global clinical trials alone has skyrocketed from two to 15 percent in less than a decade, and Asia now accounts for around 60 percent of worldwide activity. The real issue is not defending a position in the tables but making the ecosystem more attractive and efficient,” he conjectures
“Some countries can mobilise resources with notable speed, and while Europe operates under a different model, yet we must still improve our own predictability and efficiency to remain attractive and must nor rest on our laurels,” acknowledges Catherine Paugam-Burtz, director general of the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). Their first step has been to listen carefully to the concerns raised by sponsors and academic teams. “Many pointed out the need for clearer guidance, stronger methodological support and more consistent scientific dialogue. We have expanded our advisory activities to help applicants strengthen the quality of their submissions and address clinical judgment issues early, since these elements often determine the pace of the authorisation process,” she elaborates.
Additionally, at the national level, the ANSM has been developing what could soon become a structured Fast Track approach for clinical trials. “This follows more than a year of work with stakeholders and builds on pilot procedures tested to shorten timelines. The aim is to provide a more agile route for high-quality studies while maintaining the scientific standards and the patients’ security, expected of a public health agency,” confirms Paugam-Burtz.
Also exciting, multiple initiatives are underway aimed at enabling decentralised trials and rethinking clinical trial design. “A multitude of stakeholders have been testing innovative methodologies such as the use of real-world data to emulate patient cohorts or the creation of virtual trial arms, that can keep our country ahead of the game,” reflects Escurat.
Frederic Collet, Chairman of the Filière Intelligence Artificielle et Cancers (FIAC), for example, is leading a pioneering public-private consortium bringing together nine of the world’s most innovative oncology companies with France’s public health institutions with a view to maturing AI-driven cancer research pathways. “Innovation has shifted from science to technology and is now anchored in data. Simultaneously, machine learning is opening considerable up new opportunities in spheres such as digital clinical trial arms, AI-enabled data collection, and enhanced patient pathways,” he conjectures.
“France’s heritage in this domain is particularly strong, thanks to longstanding cancer registries, and decades of systematic health data collection. Moreover, much of the data is held by public institutions and represents a national asset, meaning that the country could potentially assert itself as a real leader pioneering these approaches,” believes Collet.
Likewise, Alain Puisieux, Chairman of the Executive Board at the Institut Curie views France as an obvious destination for biomarker-driven trials of the future. “There’s a strong case for focusing upon early-phase, biomarker-driven, adaptive trials where France maintains genuine unique advantages through our strong research-clinical continuum,” he believes.
Already, the Brain & Mind bio-cluster has been exploring such avenues. “We are presently developing frameworks for sophisticated methodological support in early-stage trials, moving beyond traditional approaches where initial indications receive substantial investment without comprehensive target product profile understanding,” recounts Alexis Genin.
“Our framework emphasises biomarker-informed and adaptive trials utilising early clinical data rather than purely clinical outcomes. The scientific consensus supports digital biomarkers’ revolutionary potential in introducing objectivity to partially objective fields, reducing inter-site investigation variability, and capturing patient data beyond artificial hospital environments to better understand drug and device performance in real-world settings. We are convinced that this represents the future and are adamant to be at the forefront of trailblazing it,” he concludes.
