Clinical Trials: France Strives to Remain Among Europe’s Top Three

France is the third most significant clinical research destination in Europe, participating in 50 percent of the trials initiated across the continent. While favourable government policies and unique strengths such as the National Health Data System contribute to France’s competitiveness, obstacles to further growth remain. In conversation with PharmaBoardroom, Hubert Mechin, president of AFCROs, discusses these strengths and weaknesses.

 

Our nation boasts robust proficiency in oncology and rare diseases

Hubert Mechin, AFCROs

A Solid Position in Oncology and Rare Diseases

France may have lost some of its clinical trials ground, but remains among Europe’s top three clinical research destinations. “While Spain may lead in certain aspects of clinical research, France still holds its own, capitalising on its strengths to remain competitive globally,” says Hubert Mechin, president of AFCROs, the association that represents clinical research organisations in France.

The country stands out especially in two disease areas. “Our nation boasts robust proficiency in oncology and rare diseases,” Mechin asserts. “These areas are focal points for clinical trials in France.” And while the country may come in third place for overall participation in international clinical trials within Europe, in oncology it comes in second with 45 percent of French trials corresponding to that field.

In the area of rare diseases, the French government has made a commitment to research into the diseases that affect some three million of its citizens, AFCROs’ president notes, with initiatives such as the Third National Rare Disease Plan (PNMR3).

France’s Unique National Health Data System (SNDS)

Leveraging this resource, we conduct numerous real-world studies, positioning France among the leaders in real-world evidence generation within Europe

One of the country’s assets when it comes to conducting clinical trials is its unique Système National des Données de Sante, or National Health Data System (SNDS).  This system links national health insurance data, hospital data, medical causes of death, data relating to disabilities, and data from supplementary health insurance organisations, offering the country an exceptional ability to benefit from real-world evidence.

“The SNDS is one of the largest clinical databases globally, accessible since 2016,” says Mechin. “Leveraging this resource, we conduct numerous real-world studies, positioning France among the leaders in real-world evidence generation within Europe.”

For the head of AFCROs, the country’s excellent academic centres are also key to its clinical research position. “France’s academic centres play a pivotal role in driving clinical research forward,” he claims. Yet these institutions do not work alone and are “highly dynamic, engaging in a wide array of clinical trials in collaboration with both CROs and industry stakeholders.”

In Mechin’s view, the collaborative environment fostered between academia, private companies, and government entities and the partnership between the public and private sectors ensures a vibrant and diverse clinical research landscape in France.

Pro-active Government Policies … and Delays

In addition to these positives, the French government has also been actively incentivising clinical research in the country since 2019 and its Health Innovation 2030 plan aims to make France “the leading country in Europe for clinical trials.”

One of the roadblocks the industry encounters in France is the challenge of recruiting patients. “Finding eligible patients who haven’t undergone treatment yet can be difficult,” says Mechin. Under the plan, the government’s digital health delegation (DNS) set out to create national clinical trials database to boost the capacity for anticipation and the speed of recruitment.

Despite these efforts, for Leem, the organisation representing innovative pharma in France, the results of the government’s initiatives are yet to be fully seen. In the 13^th edition of its “France’s attractiveness for clinical research” report published last month; Leem argues that it still takes 160 days to initiate a clinical trial.

The president of AFCROs also sees this as an impediment to France competitiveness. “French investigators sometimes face delays, impacting the speed of clinical research. This slower pace is especially notable in areas like CNS studies, cardiovascular research, and diabetes trials,” he says. “One issue is the complexity of administrative tasks, especially in negotiating contracts with hospitals, [which] can lead to delays in getting clinical research projects off the ground.”

To achieve the goals set forth in the Health Innovation 2030 and increase the number of trials held in France, Leem argues that France has to simplify its requirements, eliminating the need for authorisation to export and import biological samples, introducing “fast tracks” to ensure that trails can begin within 120 days for patients with no therapeutic alternative, and adapting the legislative framework for decentralised clinical trials.

Lagging Behind in Decentralised Trials

With respect to decentralised and hybrid clinical trials incorporating digital advances, Mechin agrees that France is not fully exploiting its potential. “France certainly has a hold on technology,” he asserts. “However, post-COVID, regulatory hurdles have emerged as a significant challenge. Convincing regulatory bodies of the viability of these tools remains an ongoing struggle.”

For the head of the clinical research association this lack of agility also stands to impact France’s competitive edge. “This cautious approach may result in us losing ground to countries that are more agile in adopting these innovations.”