The Challenges of Democratizing Clinical Research in General Hospitals in France

How Are the Legislative and Regulatory Frameworks Governing Clinical Research Evolving in France?

Since the 1958 Debré Ordinance, medical research has been recognized as a fundamental mission of the hospital system, initially entrusted exclusively to university hospitals (CHUs), particularly through their Clinical Research and Innovation Departments (DRCIs). From that moment on, CHUs, alongside other research institutions such as INSERM and CNRS, became key players in medical research. This research has been a strategic priority for university hospitals, allowing them to maintain their unique role in France’s healthcare landscape.

Over time, the law has expanded research responsibilities to all healthcare institutions. Initially exclusive to CHUs, clinical research became a recognized mission for public hospitals in 1991. Then, in 2009, the Hospital, Patients, Health, and Territories Reform Act introduced 14 public service missions that could be carried out by healthcare institutions, whether public, private non-profit, or private for-profit; clinical research was one of these missions. The 2016 Healthcare System Modernization Act later repealed the concept of public service missions but maintained the principle that clinical research could be conducted by all types of healthcare institutions.

The Challenges of Democratizing and Energizing Clinical Research in General Hospitals

For a hospital director working in a CH, supporting the development of clinical research within the institution presents multiple benefits, particularly in an era of demographic challenges.

Challenge n°1: Providing Higher-Quality Care

The primary goal is to offer patients better care. Clinical research in CHs makes research more widely accessible, providing patients with innovative therapeutic approaches and advanced medicine. Moreover, through Good Clinical Practices (GCP) and the methodological rigor inherent to research, clinical research positively impacts all hospital departments, improving overall care quality for all patients—not just those involved in research protocols.

Challenge n°2: Increasing Hospital Attractiveness

Clinical research enhances the hospital’s appeal to healthcare professionals. While research is not mandatory for hospital practitioners (PHs) without academic status, the 2011 Toupiller report on medical practice in hospitals found that over 70% of surveyed physicians considered research and scientific publications important factors in their hospital careers. Offering support from a clinical research unit allows medical staff to learn from peers, share knowledge, and collectively contribute to medical and scientific advancements—helping attract and retain top talent amid medical workforce shortages.

Challenge n°3: Strengthening France’s Position in Global Research

Expanding clinical research in CHs also benefits France’s standing in the competitive global research landscape, contributing to medical knowledge and advancements in human health. These factors explain why the development of research in general hospitals is receiving growing support.

Key Success Factors for Implementing Clinical Research Projects in General Hospitals

Several critical success factors are necessary for deploying clinical research projects in any healthcare institution, including general hospitals:

• Adequate infrastructure: Access to state-of-the-art equipment, specialized personnel, and dedicated research spaces.
• Strong financial resources: Securing public funding, public-private partnerships, and internal budgets to support research initiatives.
• Leadership commitment: Encouraging continuous training and fostering a research-oriented culture within the hospital.
• Institutional and regulatory support: Streamlining administrative processes and ensuring compliance with regulations to facilitate research projects.
• Patient engagement: Informing patients, obtaining informed consent, and valuing their participation to ensure the success of clinical trials.

Additionally, some success factors are specific to general hospitals:

• Enhancing research visibility: Promoting clinical research both internally (among medical staff) and externally, making it a strategic part of the hospital’s institutional vision.
• Expanding research fields: Encouraging participation from all medical disciplines and integrating paramedical research, with the ultimate goal of CHs sponsoring clinical studies.
• Building strategic partnerships: Leveraging regional networks to professionalize clinical research and capitalizing on CHU collaborations to benefit from existing medical networks.

When these conditions are met, general hospitals can become dynamic and innovative players in clinical research.

The Rise of General Hospitals in Clinical Research

A Historical Dominance of CHUs

Currently, most clinical research in France is still conducted within CHUs. For example, half of all clinical research takes place within AP-HP hospitals, France’s largest CHU network and leading producer of scientific publications. In 2021, AP-HP had nearly 4,385 ongoing research projects. While this highlights the dominance of CHUs, it should not overshadow the growing role of CHs in leading research initiatives. This trend is particularly visible in the allocation of funding from the MERRI (Teaching, Research, Reference, and Innovation Missions) program, which has been available to CHs since 2011.

Increasing Financial Support for General Hospitals

In 2021, according to the National Research Coordination Committee (CNCR), more than 90 CHs received MERRI funding, totaling approximately €92 million—representing 5.1% of the total budget. In comparison, only 21 CHs received such funding in 2012, capturing just 2.4% of the total. This means that both the number of CHs receiving these funds and their share of the total budget have more than doubled. These funds have helped CHs establish dedicated research units and hire specialized personnel. Moreover, in 2020, CNCR reported 105 studies sponsored by CHs, compared to just 7 in 2011—representing 2.5% of all French clinical studies during that period.

Strengthened Coordination Between CHUs and General Hospitals

At the regional level, clinical research is becoming increasingly structured, with CHUs and CHs collaborating rather than competing. Beyond these territorial dynamics, a growing number of CHs participate in research programs, cohort studies, registries, and national or international randomized trials.

The democratization of clinical research in general hospitals over the past fifteen years marks a significant shift from the historical dominance of university hospitals. Thanks to legislative reforms and increased support, CHs now play an expanding role in research. This evolution enhances care quality, boosts hospital attractiveness, and strengthens France’s global research position. However, success depends on key conditions such as proper infrastructure, sufficient funding, and strong leadership and patient involvement.

Alcimed supports all players in the medical research ecosystem—both established and emerging—in navigating this evolving landscape. Feel free to contact our team!

About the author,
Mathilde, Consultant in Alcimed’s Innovation and Public Policy team in France.