About clinical trials

A clinical study involves human volunteers and is conducted to test a medicine or medical device. These studies are designed to provide data on the safety and effectiveness of a treatment.

An observational study is conducted with a marketed product, examining it under its approved conditions of use.

An interventional study, on the other hand, involves a test product, typically a medicine or medical device. These studies are performed to assess the safety and efficacy of the product. They are classified into four successive phases.

This website includes only interventional studies, also known as clinical trials, where Servier is the sponsor.

Additionally, it may contain clinical data from medicines developed in partnership with other organizations, with their agreement.

After research in animals, clinical trials are performed in humans to test how the medicine will work in people. The development of a medicine goes through several stages, known as the phases of development. The aim is to ensure that a medicine is safe, effective, and complies with all Health Authorities’ requirements. Typically, clinical medicine development is divided into four successive phases:

• Phase 1: These studies involve administering a new medicine to humans for the first time. The medicine is tested on a small group of people to determine its safety and appropriate dosage. For example, the highest safe dose may be identified. These studies help establish the best way to use the medicine. Phase 1 usually includes 20 to 100 healthy volunteers or people with the disease and lasts several months.
• Phase 2: These studies focus on the efficacy of the medicine in people with the disease. The group includes up to several hundred participants. The studies also assess the proper dosage and safety of the medicine, comparing it to a placebo or other treatments. Phase 2 studies last from several months to several years.
• Phase 3: Once the medicine has proven to be effective in Phase 2, Phase 3 studies are conducted. They assess the efficacy and safety of the medicine in a larger group of people with the disease, including up to several thousand participants. These studies provide evidence for marketing approval and may compare the medicine to other treatments or a placebo. Phase 3 studies can last up to several years.
• Phase 4: Phase 4 studies are carried out after the medicine has been approved by a Medicines Agency. The goal is to gather more information about the medicine’s effectiveness and safety. If the medicine is studied under its approved real-life conditions of use, the Phase 4 study is considered an observational study. It reviews safety over a long period and may also examine other aspects of the treatment, such as quality of life, cost, or overall effectiveness.

Clinical studies are crucial for improving our knowledge about a medicine’s safety and efficacy. Before a medicine can be placed on the market, several clinical trials must be conducted to assess its benefits and risks. The results of these studies are submitted to Medicines Agencies, which use the data to determine whether the medicine is effective and safe for patients.

In general, a study doctor leads the clinical trial, supported by a research team that may include other doctors, nurses, social workers, and various healthcare professionals.

Clinical studies can take place in a variety of locations, such as hospitals, universities, and doctors’ offices. The specific location depends on who is conducting the study.

A clinical study is conducted according to a research plan known as the protocol. This protocol is designed to answer specific research questions while safeguarding the health of participants. It contains the following information:

• The reason for performing the study
• What information will be collected about the participants
• Who can participate in the study
• The number of participants needed
• The schedule of tests, procedures, or medicines and their dosages
• The length of the study

Both adults and children may participate in clinical studies. Each clinical trial defines specific eligibility criteria for participants. The study protocol outlines the factors that include or exclude potential participants, ensuring that only individuals who match the required characteristics for the study are included.

Participants must receive an informed consent document that provides sufficient information to understand the potential benefits and risks, as well as available alternatives.

Before participating in a study, individuals must sign this informed consent document. The signature indicates that they have received all relevant information about the study and understand it. Signing the document and giving consent is not a contract; participants may withdraw from the study at any time, even if the study is not yet complete.

Each study must obtain approval before starting, which is granted by a Medicines Agency and/or an Ethics Committee.

An Ethics Committee, composed of doctors, researchers, and community members, ensures that ethical standards are upheld and protects the rights and welfare of participants.

For studies involving healthy participants, there are typically no direct health benefits from participating.

For studies involving patients, the potential benefits are uncertain. At the beginning of a clinical study, it is unknown if or to what extent the study will be beneficial to the participant. The purpose of the study is to test the medicine and observe its effects on people with the disease. During the study, participants might experience improvement, no change, or a worsening of their condition.

For all studies, the information gained can contribute to advancing medical knowledge and potentially aid in the development of future treatments.

All expenses generated by the study are covered by the sponsoring organization. For studies involving healthy participants, financial compensation may be provided for their time and involvement.

Before reaching clinical trials, the medicine is tested at different doses in laboratories to study its safety and side effects.

During a clinical study, participants may or may not experience the benefits of the medicine, depending on the phase of development. Side effects may also occur.

Throughout the study, doctors and nurses will carefully monitor participants’ health. They will record any problems or side effects and take appropriate medical measures to ensure participants’ safety.

The sponsor is required to take out an insurance policy to cover any risks related to the study.

The participants’ study records will remain private and confidential. Some people or organizations may need to access the study records, either globally or partially, for quality assurance or data analysis. Anyone who looks at the records must keep them completely confidential. These people or organizations include:

• The study doctor who leads the clinical trial and the research team
• Regulatory agencies and ethics committees
• The sponsor of the study and their representatives
• Academic or medical researchers

The findings from the study may be published and used in the following ways:

• In scientific reports or articles showing the results
• Forwarded to regulatory agencies
• Made public

Regardless of the purpose, names will not be included. Nothing will be published that would reveal the identities of the participants.

Yes, the results of a study will be made publicly accessible. A summary of the results in lay language will be available on the dedicated study page that you can find on Find Clinical Trials.

The summary will be available:

• After the study has concluded
• Once the results have been analyzed

Clinical studies at Servier are managed by two company structures:

• IRIS (Institut de Recherches Internationales Servier): Typically responsible for conducting phases 1 to 3 of clinical studies.
• GMA (Global Medical Affairs): Handles late development stage studies, including some phase 3 and all phase 4 studies.