What you need to know about the Leem survey on the competitiveness of clinical research in France

Since 2020, the COVID-19 health crisis allowed some breakthroughs to be made, despite the many disturbances generated. This is particularly true of French clinical research, where innovation and production capacities have more than ever been highlighted by the many clinical trials conducted to develop treatments and vaccines against COVID-19.

Beyond clinical research, associated challenges were also highlighted during this period, such as early access to innovative treatments for patients, the promotion of French know-how, the attractiveness of the region for local and foreign manufacturers, and the development of healthcare professionals’ expertise. In this article, Alcimed’s healthcare team deciphers for you the 12th edition of the French Clinical Research Competitiveness Report, which looks ahead to 2021.

A strong position in Europe and a global presence in oncology

France on the European podium

In Europe in 2021, France was in second place in terms of participation in clinical trials conducted on patients, tying with Germany (participation in 13% of clinical trials conducted in Europe) while Spain ranked first (16%).

Oncology is the preferred therapeutic area in France

As has been the case for several years, oncology remains the preferred therapeutic area for clinical trials conducted in France, accounting for 45% of clinical trials conducted in France in 2021.
This specialization is confirmed at the continental level, as France moves up to second place in the European ranking for oncology (participation in 15% of clinical trials, all phases combined), with Spain (19%) once again in first place. Similarly, France ranks second in Europe for early-stage clinical trials in oncology. This influence is even more pronounced on a global scale, with France ranking fourth in this field, participating in 15% of global oncology trials (behind Spain, China, and the United States).

However, France is still excluded from certain clinical trials

While the report shows that French expertise remains strong in its preferred fields, notably oncology, it also highlights France’s exclusion from certain clinical trials. 333 international clinical trials including European countries did not include France in 2021 (out of 3,684 clinical trials sponsored by the industry worldwide). Additionally, nearly 30% of these trials focus on oncology, despite France’s privileged position in the field – a further sign of the competitive intensity between the different European players.
The LEEM survey also highlights the very low proportion of clinical trials (less than 1%) sponsored by companies and conducted exclusively in France. This is even more striking when compared with the United States (18%) and China (16%).

Faster launches of clinical trials make France more attractive to manufacturers

Shorter regulatory deadlines

France is often criticized for its heavy clinical trial regulations, which can constitute a threat to its competitiveness with other countries. For several years now, however, real efforts have been made to reduce regulatory timelines (including authorizations from the National Agency for the Safety of Medicines and Health Products (ANSM) and the “Comité de Protection des Personnes” ethics research committee) between the first clinical trial submission and the inclusion of the first patient.
In 2021, it took an average of 174 days to include the first patient in a clinical trial, compared to 204 days in 2019. A similar trend was observed in oncology, with an average of 182 days versus 204 in 2019. It is interesting to note that 2020 is not included in this comparison, due to the exceptionally accelerated timelines for COVID-19 clinical trials.

Which are possible to shorten further

While regulatory timeframes are generally moving in the right direction, LEEM continues to encourage the French authorities to work towards reducing them even further in the coming years. As an example, the time taken to sign the single agreement contractually binding the coordinating center and the clinical trial sponsor is on average 38 days longer than that normally provided by law.
Among the opportunities for improvement, LEEM also suggests that clinical trial sponsors be given more extensive support, particularly with regard to the use of CTIS (Clinical Trial Information System), the platform enabling sponsors to communicate with all regulatory bodies. Better communication between the various stakeholders would, once again, speed up setting up a clinical trial in France, while maintaining the same high expectations.

France’s competitiveness is threatened by changes in clinical trial funding methods and international competition

Social Security Financing Bill and clinical trial funding

In addition to contractualization deadlines that are still considered too long, LEEM specifically highlights the Social Security Financing Bill project lead by the government in early 2023.

One of the measures considered in the project addresses clinical trial financing. For the most expensive treatments, the French government is considering a system of payment in several installments by the Assurance Maladie, rather than a single payment: funding could be split up and issued as the clinical trials progress and results are observed, according to a timetable drawn up between the government and the manufacturer, and performance criteria defined on a case-by-case basis. If these criteria are not met, payments may be suspended.

Thierry Hulot, President of LEEM, is concerned about the risk this bill poses in terms of attractiveness for French clinical research. According to him, such measures could discourage manufacturers from conducting their trials in France. However, this system already exists in other European countries. For example, Italy’s national medicines agency (AIFA) has signed a “performance” agreement with Novartis for the administration of Kymriah® (CAR-T) to around 100 patients in 10 institutions: the 3-installment payments over 1 year is conditional on the survival rate observed in the cohort.

A threat on a continental scale

Despite the situation being stable in France, the report highlights the increasingly significant gap between Europe on the one hand, and Asia and the United States on the other. In particular, Asia has moved into first place in terms of clinical research in oncology, participating in 51% of clinical trials. It is followed closely by the United States, which participates in 49% of these trials, leaving Europe far behind (32%).

In 2021, France has maintained its position of excellence in clinical research. With a solid European ranking and a global presence in oncology, France continues to benefit from the renewed interest in clinical research observed since 2020. The increasing flexibility of certain regulatory timelines, which is speeding up the launch of clinical trials and improving the country’s competitiveness to industry, has contributed to this new momentum.

However, there is still room for improvement in terms of contractual deadlines, and a need for concerted action between the industry and the French government, particularly regarding changes in the way clinical research is financed. Alcimed is closely monitoring developments in this area and is ready to support you on these matters. Don’t hesitate to contact our team!

About the author, 

Henri, Consultant in Alcimed’s Healthcare team in France
Lambert, Project Manager in Alcimed’s Healthcare team in France