CRO for Clinical Trials in France

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

17 January, 2022

CRO for Clinical Trials in France

If you need a Clinical Research Organization (CRO) for clinical trials in France, please contact us at info@sofpromed.com 

France is one of the most attractive countries to conduct clinical trials at both European and international level. The prestige enjoyed by this nation lies in its historical as well as current competitiveness in the health sector, its eagerness for constant improvement, and its outstanding ability to adapt to the ever-changing regulatory environment. 

Read on to explore in more detail the main aspects which make France an exemplary country with regard to the conduct of clinical analysis and research. 

France: One of the Top Countries for Clinical Trials in Europe

France has traditionally left a legacy of commitment to the field of medicine and productivity in the execution of clinical trials. Indeed, the priority given to clinical investigation has reached such a degree that it has become one of the fundamental pillars upon which global scientific progress as well as the country’s economy and stability are built. 

This proficiency, acquired thanks to a great deal of effort and dedication, is evidenced by the fact that France is among the five European countries with the highest percentage of clinical trials. 

As an illustration, according to the American clinical trial database (clinicaltrials.gov), the total number of clinical trials carried out on French territory as of January 2022 is 30,134. It represents a large proportion, taking into consideration the number of studies conducted in Europe and in the world, which amount to 115,383 and 400,873, respectively. 

By way of comparison, other figures collected in neighboring countries are as follows: Germany (22,244), Spain (16,530), Italy (16,168), Belgium (11,367), and the Netherlands (10,756), among others. [1] 

Further evidence of the position of France as an internationally acknowledged leader in the clinical trials market is provided by Frédérique Fauduet, Pharm-Olam’s Director of Clinical Development. She emphasizes not only the country’s devotion to the scientific and academic spheres, but also the recent enhancements in the clinical trial regulatory process, and the expertise of eminent health care specialists who work at the renowned French medical institutions. [2] 

French Regulatory Framework for Clinical Trials 

Now that we have become more familiarized with the part played by France in the conduct of clinical studies, below we will focus on the legal and normative framework for clinical research in this country. 

In France, the Ethics Committee and the Competent Authority are responsible for the evaluation and approval of clinical trials. Nevertheless, prior to the beginning of the study, it is also necessary to comply with a series of specifications and standards required by other stakeholders. 

As for laws, regulations, and decrees that should be complied with to guarantee the quality review of clinical research studies, these are available for consultation on the website of the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the competent authority in France. It can be accessed by those sponsors or delegated CROs that are interested in submitting the online applications. 

In terms of data protection approval, an application has to be submitted to the Comité Consultatif sur le Traitement de l’Information en Matière de Recherche dans le Domaine de la Santé (CCTIRS), one of the two committees assuring the protection of data privacy. Then, the other committee, the Commission Nationale de l’Informatique et des Libertés (CNIL), will be informed by a “declaration of biomedical research” that can be found on its website. [3] 

As regards site contract negotiation, the Law Bertand (2011) states that healthcare professionals must be paid fair fees. Moreover, it reviews the contracts between the industry and medical practitioners. 

Depending on the number of parties involved, these contracts may be either bipartite, with the physician, or tripartite, if both the physician and the hospital take part. 

Other issues include the growing complexity of start up activities in this region, the fact that regulation is subject to continuous alterations, and the increasingly high levels of competition in the clinical trials market worldwide. 

Hence, it is strongly advisable that sponsors initiate start up processes as early as possible to prevent last-minute difficulties regarding the negotiation of contracts or the preparation of submissions. 

Ethics Committees Approval for Clinical Trials in France

Whenever human subjects are involved in a clinical research study, it is not sufficient simply to respect national and international legislation. Beyond that, the compliance with ethical principles and values is also necessary to assure the acceptability of a clinical project requiring experimentation on human subjects. 

Throughout the second half of the twentieth century, a number of documents were created to establish a series of standards on fundamental freedoms and human rights for those cases. Of particular interest among these are the Nuremberg Code (1947), the Declaration of Helsinki (1964), and the National Research Act (1974). 

In the French context, national laws and regulations still governed the authorization of research studies on human subjects in France in the early twenty-first century. Some examples of relevant landmark laws in this location include: the Huriet-Sérusclat law (1988) and the French Data Protection Act (1978). 

However, due to the application in recent years of a list of laws and regulations approved in Europe, the country’s previous legislation has been drastically modified. In other words, the national normative landscape has been modified and shaped by new European legal rules to meet international standards. 

Nowadays, all research projects involving humans in the health, human, and social areas must go through a research ethics committee, which will assess the acceptability of the investigation before its commencement. 

The Inserm Ethics Evaluation Committee (CEEI), also known as the Inserm Institutional Review Board (IRB) is registered with the Office for Human Research Protections (OHRP). Its purpose is to provide investigators with assistance and ethical consideration. These procedures are paramount to ensure that research studies on human subjects are compliant with internationally agreed ethical principles. 

Why Is France a Leading Country to Conduct Clinical Trials? 

There are certainly numerous contributory factors which determine the conception of France as a leading country in clinical research and, by extension, its eligibility as a place to conduct clinical trials. 

First, it is clear that the large size of the country’s population has a marked impact on the area of health care. At present, France is home to over 67 million inhabitants, which translates into more patients requiring medical assistance. 

Consequently, this leads to an increasing demand for new drugs and treatments to prevent, detect, diagnose, treat, and control all types of diseases. In particular, this has significant implications for hospitals and health care professionals, especially in major French cities such as Paris, Marseille, or Lyon which are generally more affected. 

Second, it is also crucial to stress the high quality of the French healthcare system. It is funded by the government through a health care insurance program and, although the GDP spent on healthcare in France is about 50% lower than it is in the United States, the former continues to be one of the major investors in Europe. 

The healthcare system in France undertakes to cover about 70% of the medical expenditures. Additionally, in the event that any expensive or prolonged services are needed, patients are expected to be fully refunded. 

Some of the main advantages of the French medical system include [4]: 

  • Improved access to healthcare 
  • Greater access to specialized attention 
  • Focus on preventive care and promotion of healthy habits 
  • Medical practitioners are paid a decent salary 
  • Patients’ freedom to choose their own physicians 
  • A free medical checkup every 5 years 
  • Partial coverage of alternative treatments and private services 

Moreover, it should be noted that France stands out for the service quality and reputation of its well-known hospitals. For example, among the most outstanding cancer hospitals and medical research centers in this region are: the American Hospital of Paris, the Institut Curie Hospital, and the Oncological Institut Gustave Roussy. 

With respect to therapeutic areas, France is a very attractive target country to conduct clinical trials in oncology. This results from the sum of €5 billion spent on Clinical R&D in this nation as well as the strictness of the laws regulating the policy on medical products. 

The clinical trials conducted in France consist of three phases aimed at evaluating the effectiveness and safety of developing drugs, products, and therapies for the treatment or prevention of different types of cancer. To this end, the French health authorities endeavor to ensure that the toxicity, optimal dose, risk/benefit ratio, and the target patients of the new drug are properly assessed in order to firmly conclude whether it is suitable for sale or not. 

In practice, cancer and rare diseases are the two therapeutic areas to which French clinical investigators pay the closest attention. They put France in a strategically important position, ahead of many other European countries, among which are Germany and the United Kingdom. 

On a global scale, France is not being left on the sidelines either. As a matter of fact, the average of patients recruited per active center in the area of rare diseases is 4.2, thus exceeding the average in Europe (3.9) and in the world (3.7). [5] 

As already indicated, the aforementioned areas represent a considerable investment in clinical trials, yet other therapeutic areas, especially those concerned on diabetes and cardiovascular diseases, are gaining more prominence in the clinical research environment. 

Ultimately, France owes much of its clinical success to the “Jardé Law”, which came into force in 2016. It was elaborated with the aim of replacing the previous law regulating medical device trials in France since 2004, the “Hurriet Law”, and thus be more in line with the legislations governing clinical trial practices in other European countries. 

Thanks to the approval of the Jardé Law, medical devices are no longer provided free of charge in all cases. By all means, the legislative changes introduced by this new law succeeded in facilitating the conduct of certain postmarketing studies. 

Had it not been for the adoption of this law, France would probably not be the large market for medical devices that it is today. 

How Can Sofpromed Help in Conducting a Clinical Trial in France? 

Sofpromed is a clinical research organization (CRO) specialized in the management of phase I-IV clinical trials across multiple therapeutic areas. We provide support to biotech and pharma companies planning to conduct clinical studies in France, including services such as French site selection, study start-up, ethics committee and regulatory submissions, site contracting, monitoring, site management, data management, statistical programming, and project management, among others.

Conclusion 

All in all, there are many reasons to regard France as an ideal country for conducting and investing in clinical trials. Not only is France located in a strategic position, the heart of the European continent, but it also has deserved international recognition by virtue of its professional and institutional excellence in the field of health, which places this nation in an enviable position in the clinical trials market. Therefore, taking everything into account, it is not surprising that France remains one of the leading countries when it comes to conducting clinical studies. CROs can provide the local support needed to successfully execute clinical trials in French sites.  

If you need a Clinical Research Organization (CRO) for clinical trials in France, please contact us at info@sofpromed.com

References: 

[1]      Clinicaltrials.gov. “See Studies on Map.” [Accessed 5th January 2022]. https://clinicaltrials.gov/ct2/search/map/click?map.x=637&map.y=214&mapw=1239 

[2]      French Healthcare. “Clinical Trials: Choose France.” Health Science Clinical Research. [Accessed 5th January 2022]. https://www.fcrin.org/sites/default/files/u207/fiche_cnapec_french_healthcare_essaisclinique_uk_01.pdf 

[3]      CROMSOURCE. 2014. “Clinical Research in France: An Introduction.” [Accessed 12th January 2022]. https://www.cromsource.com/wp-content/uploads/2012/12/Clinical-Trials-in-France.pdf 

[4]      Gaille, Louise. 2018. “17 France Healthcare System Pros and Cons.” Vittana: Personal Finance Blog.org. [Accessed 10th January 2022] https://vittana.org/17-france-healthcare-system-pros-and-cons 

[5]      Medifrance Solution. “Clinical Trials in France: Is It Possible to Get In?” Clinical Trials in France: A Comprehensive Guide and How to Get In [Accessed 12th January 2022] https://medifrancesolution.com/news/clinical-trials-in-france-a-comprehensive-guide-and-how-to-get-in/ 

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com