International competition in clinical research is intensifying day by day. But France has lost its attractiveness in this area in recent years, in particular because of the time required to launch a trial. However, the stakes at stake are colossal.
- In 2017, in Europe, France participated in 11.9% of these studies (i.e. 313 trials), compared to 14.2% in 2015.
- In France, it takes seven months for a clinical trial to be set up, which is much longer than in other countries.
- The Covid crisis has however shown that it is possible to go much faster by reducing the administrative hazards.
At a time when the world is facing a pandemic such as it has never known before, researchers are competing to find a treatment to overcome Covid-19. On the eve of confinement in France, i.e. three months after the appearance of SARS-CoV-2 in China, more than 800 studies had already been carried out to find a vaccine on a planetary scale, according to The Lancet. Among them, 330 took place in particular in China, 125 in the United States and 45 in France. An unimpressive figure for a country renowned for its medical excellence.
But it is clear that this decline does not date from the appearance of the current pandemic. Between 2015 and 2017, the United States/Canada Zone participated in 57% of new industrial trials carried out, far ahead of Europe (38%), according to LEEM (the French pharmaceutical industry union). In 2017, on the old continent, France participated in 11.9% of these studies (i.e. 313 trials), compared to 14.2% in 2015. Today, it therefore comes in fourth position in this field. behind the United Kingdom (17.9%), Germany (17.3%) and Spain (14.5%).
A setback mainly attributed to the slowness necessary to set up a clinical trial. Indeed, in France, it takes seven months between a first request for authorization and the inclusion of the first patient in a trial.
Because the latter can only be launched after the promoter has received the agreement of the National Agency for the Safety of Medicines (ANSM) and the Committees for the Protection of Persons (CPP), in charge of assessing the risks. And if in 2018, the public authorities, the LEEM and the ANSM worked to reduce the authorization deadlines for the latter to 46 days, things have however become complicated on the side of the CPPs.
An unfortunate draw
“In the past, CPPs were specialized in cardiology or oncology, for example. The sponsors of clinical trials therefore knew exactly who they had to contact according to the research protocols. But two years ago, a law was passed on the drawing of lots for CPPs. The latter then found themselves having to analyze protocols that were not in their area of expertise and this led to delays in the rendering of decisions, “explains Christopher Le Tourneaumedical oncologist in charge of the department of early clinical trials at the Institut Curie, at Pourquoi Docteur.
“This is how the French have become less competitive than other countries where manufacturers have preferred to develop their molecules”, adds Fabrice Barlesi, medical and clinical research director at Gustave Roussy. For the specialist, “we need specialized offices in the CPP, sufficiently expanded in terms of human resources. At present, these committees stop in August. In the United States, in Germany or in Canada, this kind of thing does not exist”. Also, it would probably be necessary to remunerate the staff of the CPPs, who are currently volunteers unlike in other countries, suggests Christophe Le Tourneau.
Excellence in oncology
But French clinical research still remains a force to be reckoned with. The French sometimes pay for the clinic internationally. As for example in 2013 when the company CARMAT saw its totally artificial heart implanted in a 76-year-old patient at the European Hospital Georges Pompidou in Paris, a world first. Beyond this trial in particular, France excels in surgery and oncology. According to the LEEM, it participates in 19% of the trials launched worldwide and 45% of the industrial trials launched on the territory for this pathology.
According to Fabrice Barlesi, this recognition was achieved in particular thanks to the molecular genomics platforms set up during the first/second cancer plan in the period 2006-2010. “But in recent years, we have had fewer innovations in this area and the others have caught up with us,” he laments. Nevertheless, many large-scale studies are still taking place, such as trials SHIVA and SAPHIR, promoted by Unicancer, “extremely important in terms of the evaluation of precision medicine which is one of the major issues”, for example.
“I think we have the means to work well. But I work in a center for the fight against cancer and these are separate establishments. There is much more flexibility in terms of the organization of work, but at the public hospital where I spent a few years, it is much more complex and there would undoubtedly be circuits to streamline. But despite all this, France manages to find its place. If these brakes were lifted, it would be really excellent”, enthuses Christophe Le Tourneau.
With 14% of the trials carried out, rare diseases are also a recognized area of excellence, assures the LEEM, which deplores the lack of studies in the neurology/psychiatry sector which are struggling to recruit patients.
The importance of having access to innovations as quickly as possible
One of the main challenges in the attractiveness of France in terms of clinical trials is to allow patients to test new drugs that have already demonstrated their effectiveness but have not yet been put on the French market.
“In the United States, bringing a drug to market after a trial can take only a few months. With us, it goes through Europe then it goes down to each country for the issue of reimbursement, where it takes time. Participating in clinical research therefore provides access to innovation for our patients,” explains Christophe Le Tourneau. If this is the “essential issue”, it also allows the research teams to acquire notoriety, ultra-modern equipment or even recognized specialists.
“Roughly speaking, there are clinical trials conducted by the pharmaceutical industry and those conducted by doctors with ideas. The more France is active in clinical research for industrial trials, the more it has the possibility of being a source of proposals and ideas that come from the doctors themselves,” continues the expert.
What’s more, “if you never handle a drug X at the time of its development, which is all the translational research that makes it possible to understand why a drug works or not, you cannot develop it. You then fall behind other countries and lose your ability to develop both clinical research and care and very high-level translational research. You are then downgraded in international competition,” adds Fabrice Barlesi.
Not to mention the economic issue related to the cost of drugs. “When you include a patient in a drug trial, the latter is paid by the promoter and not by Social Security. The more we participate in clinical trials, the more it makes it possible to reduce the financial mass linked to drugs”, summarizes Christophe Le Tourneau. Finally, beyond the financing of treatments, clinical trials attract investments on French territory which make it possible to generate often very qualified jobs, recalls the LEEM on its site.
A few ways to restore the image of France
Today, the latter is therefore working in particular to “promote the development of an ecosystem favorable to research and innovation to fuel the clinical research of tomorrow and strengthen links with basic research and forge renewed partnerships with the all stakeholders, in order to better organize the clinical research system”.
For Christophe LeTourneau, the Ségur plan presented by the government at the end of the confinement due to Covid-19 is also going in the right direction to restore the image of France. “There is this desire to try to keep talent in public hospitals where clinical research is more developed than in the private sector. We will have to see this in application, but this crisis has raised awareness and we can hope that this will make it possible to move the lines”, he explains, recalling that French medical training is “really very good”. “As long as there is good training and good doctors, there can be top-notch clinical research,” he says.
For France to become the European leader in clinical research within three years, as the government announced in 2018, it must therefore invest in human resources. “It is essential for clinical trials of indisputable quality, accepted by the international community as providing a demonstration that cannot be challenged. This can only be done at the cost of a real desire to structure, train and organize things strategically”, insists Fabrice Barlesi. For this, it is therefore also essential, it will be understood, to reduce the administrative burden.
“The Covid crisis showed it was possible to go very quickly in France with accelerated passages to the ANSM and in the CPPs at the same time. We are able to mobilize resources for a particular research. This has led to the promotion of high quality translational and clinical research. Today, it is therefore necessary to be able to mobilize all the forces in a single direction instead of scattering them in a multitude of tests which risk not succeeding”, concludes the expert.
Subject made from the LEEM file “100 questions about medicine”
Find below the LEEM sheet on the theme: “What is the place of France in clinical research?”
https://www.leem.org/100-questions/quelle-est-la-place-de-la-france-dans-la-recherche-clinique
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