Our Commitments in R&D

Transparency Enhances Research and Development

Servier conducts research programs in four major fields of medicine, positioning itself as a key player in pharmaceutical research. Our commitment to transparency ensures that our research contributes to medical progress and is shared with external researchers, enhancing research, knowledge, and patient care. This collaboration must responsibly protect patients’ rights, which is fundamental to successful data sharing and drives our Transparency Policy on clinical data.

We believe that transparency is crucial for enhancing global public health.

We publicly share the results of our clinical studies, regardless of whether the results are neutral, negative, or positive. We share results and data in various ways:

1 | Access to Clinical Trial Data

Researchers can request access to clinical trial data through the Vivli platform. This includes protocols, raw data, and clinical study reports, with personal data redacted to protect patient privacy.

This commitment applies to completed interventional clinical trials in patients, sponsored by Servier, and submitted to US and/or EU Regulatory Authorities for Marketing Authorization (MA) of new medicines or new indications approved after January 1, 2014. For products whose development was terminated before MA approval, we also share data for trials with the first patient enrolled on or after January 1, 2004.

2 | Public Registry Publication

We publish all our interventional studies in patients and their results on public registries meeting WHO criteria (e.g., EudraCT, CTIS, ClinicalTrials.gov, ISRCTN) since 2004. Summaries of results are available on these registries and this website.

3 | Lay Language Summaries

We provide lay summaries of our interventional studies published on public registries to make the results accessible to the general public.

4 | Scientific Literature Publication

We publish the results of our studies, including all phase 3 studies, in peer-reviewed scientific conferences and journals, regardless of the study outcome. Articles are submitted within 18 months of the study’s end, for studies ending after January 1, 2014.

5 | Adherence to EFPIA Transparency Principles

We publicly certify that we have established policies and procedures to implement the EFPIA Data Sharing Principles, ensuring our data transparency policy can be reviewed.

6 | Compliance with International Standards

We adhere to regulatory requirements in each country and strive to harmonize our Transparency Policy globally.

7 | Clinical Study Report Synopses

We disclose synopses of clinical study reports on this website when used to obtain a Centralized Marketing Authorization in Europe.

Glossary
US: United States
EEA: European Economic Area
WHO: World Health Organization
EFPIA: European Federation of Pharmaceutical Industries and Associations

Involving Patients Throughout the Lifecycle of a Medicine

Engaging the entire healthcare sector—not just researchers and healthcare professionals, but also patients and their families—in the development process is the most effective way to ensure the success of new treatments. Servier has embraced this approach, actively listening to patients at every stage, from research to post-treatment care.

Servier is committed to supporting patients and improving their treatment by involving them in every stage of decision-making..

A More Patient-Focused Approach to R&D

In Research and Development (R&D), patient representatives are already involved in over 25% of clinical trial projects. This involvement ensures that all aspects of a disease are considered.

Integrating patients into every stage of R&D fosters closer connections between basic and clinical research, leading to what is known as translational research.

Patients are increasingly consulted in the preparation of various research program documents, including Study Protocols, Participant Information and Consent Forms, and Study Support Materials. Through these collaborations, Servier ensures that its programs address real patient needs and that its study materials are clear, useful, and well-adapted to all study participants.

At the end of studies, patients are often invited to provide feedback about their experience. Their insights help Servier improve the quality of its studies.

To help patients access study results, lay summaries are available on this website in English. These summaries will be translated into all languages of the study participants.

At Servier, we believe that everyone has the right to access health information that empowers them to make informed decisions. To achieve this goal, we strive to communicate in everyday language, making written and oral information easier to understand. Lay language is a crucial tool in this endeavor, ensuring that our documents meet three key objectives:

• The patient can easily find the information they need.
• They can understand what they find.
• They can act appropriately based on that understanding.

Initiatives Contributing to Health Literacy

Package Leaflet

In Europe, our package leaflets are designed based on consultations with target patient groups to ensure they are legible, clear, and easy to use. We comply with the European Commission Guidelines on Readability.

Informed Consent Form (ICF)

Before participating in a study, individuals must provide their informed consent. The ICF is a written document that explains the purpose, procedures, potential benefits, and risks of the study in simple language that is easy for participants to understand. At Servier, we use an ICF template developed in collaboration with patient associations.

Lay Summaries

At the conclusion of a study, we produce a lay summary intended for the general public. This summary presents the clinical trial results in an easy-to-understand format. All lay summaries are reviewed by patient associations to ensure clarity and accessibility.

Additional Resources

Free Medical Images

Access free medical images to illustrate your publications and PowerPoint presentations at Servier Medical Art.

Official Blog

Stay updated with the latest news and insights from Servier by visiting our official blog at Servier Newsroom.

Good Clinical Practices (GCP)

Good Clinical Practices (GCP) are international standards that provide ethical and quality guidelines for designing, recording, and reporting studies involving human participants. Regardless of their location, all our studies adhere to GCP, ensuring the following:

• The protection of the rights, safety, and well-being of study participants.
• The credibility of trial data.
• Comprehensive training for all staff and study doctors.

Additionally, all our studies comply with the Declaration of Helsinki, which offers ethical guidelines for study doctors and other individuals involved in clinical research.

See also:

• ICH E6 – Guideline for good clinical practice
• Declaration of Helsinki

The development of new medicines requires thorough evaluations of their efficacy and safety, involving various steps before their first use in humans and eventual market authorization. Currently, the use of animals remains essential and legally required to discover and develop new medicines that address unmet medical needs.

Animal use is a significant responsibility for scientists and society alike. We are strongly committed to the 3R principles in animal research:

• Replacement: Replacing the use of animals with non-animal methods whenever possible.
  • Applied whenever a suitable alternative is available.
• Reduction: Reducing the number of animals used to a minimum while still obtaining scientifically valid results.
  • Involves a complex evaluation to determine the exact number of animals needed to achieve scientific and legal objectives.
• Refinement: Refining practices to minimize stress pain, suffering, distress or lasting harm that may be experienced by research animals.
  • Continuous improvement of methods to enhance animal welfare.

As long as animals are necessary for the benefit of patients, ethical principles for their use will be at the core of our research.

The foremost principle is to use animals only when there is a scientific and/or legal reason and no other option is available. For example, at the beginning of development, we select candidate medicines using in silico or in vitro methods. Consequently, only the most promising candidates proceed to the stages requiring animal studies.

Additionally, regulatory requirements evolve through the application of the 3Rs principles (Replacement, Reduction, Refinement), as outlined above and on the EMA website.

Our Research and Development activities adhere to various national and international regulations and standards that incorporate the 3Rs principles. We comply with, and often exceed, these regulations, including:

• European Directive 2010/63 related to the protection of animals used for scientific purposes.
• French transposition of this European Directive (February 2013), including the National Charter on Ethical Principles Applied to Animal Research.

We remain dedicated to upholding these ethical standards in all aspects of our research involving animals.