About Clinical Trials

Understanding Clinical Trials

This page gives an overview of Servier’s clinical trials. It may be of interest if you are thinking about participating in one of them. It will also give you some details if you would like information about on-going clinical trials.

 

It is a study with human volunteers. It is carried out to test a medicine or a medical device. Such studies are designed to provide data on whether a treatment is safe and effective.

An observational study is carried out with a marketed product. The product is studied under its approved conditions of use.

An interventional study is carried out with a test product. Usually, the test product is a medicine or a medical device. We perform the study to assess the safety and efficacy of the product. The studies are classified into 4 successive phases.

This website only covers interventional studies where Servier is the sponsor. Interventional studies are also called clinical trials.

This website may also contain clinical data from medicines developed with partners with their agreement.

After research in animals, we perform clinical trials in humans. They assess how the medicine will work in people. The development of a medicine has to go through several stages. They are called the phases of development.

The aim is to ensure that a medicine is:

  • safe,
  • effective,
  • and complies with all the Health Authorities’ requirements.

Usually, we divide clinical medicines development into 4 successive phases.

Phase 1: These are the first studies in humans. The medicine is tested on a small group to assess the safety and the dose. For example, we may test the medicine to find the highest safe dose. These studies help us to assess the best way to use the medicine. The phase usually includes 20 to 100 healthy volunteers or people with the disease. The phase lasts several months.

Phase 2: These studies focus on the efficacy of the medicine. We test the medicine only on people with the disease. The group includes up to several hundred people. The studies also assess the appropriate dose and the safety of the medicine. They last from several months to several years.

Phase 3: Once the medicine has proved to be effective in phase 2, we test the medicine only on people with the disease. Phase 3 studies assess the efficacy and safety of the medicine in a larger group. The group includes up to several thousands of people. Sometimes these studies are called pivotal studies. This means that the purpose of the study is to provide evidence for marketing approval. During phase 3, the medicine may be compared to other treatments in order to find out which is more effective and safe. The phase 3 studies can last up to several years.

Phase 4: At this stage, the medicine has been approved by a Medicines Agency. Even after testing on thousands of people, the full effects of the medicine may not fully be known. Some questions may still need to be answered.

If the medicine is studied under its approved and in real life conditions of use, the phase 4 study is an observational study. It is used to review safety over a long period of time. The study may also look at other aspects of the treatment, such as quality of life,  cost or effectiveness.

If the medicine is studied for unapproved uses, the phase 4 study is called an interventional study. It assesses new uses, such as new patient populations or new diseases.

A study is intended to improve our knowledge about the medicine’s safety and efficacy.

Before a medicine can be placed on the market, we have to perform several clinical trials. Clinical studies are used to assess the benefits and risks.  We pass on the results to Medicines Agencies. With these results, Medicines Agencies will decide whether it is effective and safe for patients.

In general, a study doctor leads the clinical trial. A research team is also involved. The team may include other doctors, nurses, social workers and other healthcare professionals.

It can take place in many locations (hospitals, universities, doctors’ offices, etc.). The location depends on who is conducting the study.

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

  • The reason for performing the study
  • 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
  • What information will be collected about the participants

Adults and children may participate. Each clinical trial defines who is eligible to take part in the study. The protocol outlines the factors which include or exclude a potential participant. The study must include only people who match the required characteristics of participants for that study.

A participant must receive an informed consent document. It should give enough information so that potential benefits and risks can be understood. It should also tell participants about the alternatives.

A person must sign this informed consent document before participating to a study. The signature shows that he/she has all relevant information about the study and that he/she understands it. Signing the document and giving consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over yet.

Each study must obtain approval before starting. It is given by a Medicines Agency and/or an Ethics Committee.

An Ethics Committee includes doctors, researchers and members of the community. They check that the rules of ethics are applied. They also protect the rights and welfare of participants.

In the case of studies in healthy people, they receive no health benefit(s) by participating.

In the case of studies in patients, we do not yet know if this study will help you or to which extent it may help you. We are testing the medicine to look at its effects on people with the disease. During the study, participants might get better, but their condition could also stay the same or even get worse.

For all studies, we hope the information we find out will help other people with the same disease in the future.

We cover all the expenses generated by the study. In the case of studies in healthy people, participants may receive financial compensation for their time.

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

If you are participating in a clinical study, you may or not experience the benefits of the medicine depending on the phase of development of the product. Side effects may also occur.

During the study, doctors and nurses will carefully monitor your health. They will record any problems or side-effects you have and will take appropriate medical measures. They will make every effort in order you are kept safe.

The Sponsor must take out an insurance policy. It covers any risks relating to the study.

Your study records will stay private and confidential. Some people or organizations may need to look at your study records, globally or partially. They will look at your study records for quality assurance or data analysis. Anyone who looks at your records must keep them completely confidential. People or organizations include:

  • a 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.

 

We may publish what we find out from this study. We may:

  • use the results in scientific reports or articles showing the results,
  • forward results to the regulatory agencies,
  • make the results public.

Whatever the aim, we will not include your name. We will not publish anything that would let people know who you are.

Yes. You can ask the study doctor for a summary of the results in lay language for the study in which you participated. It will be available:

  • after the end of study,
  • and when the results have been analyzed.

Two company structures manage clinical studies at Servier:

  • IRIS (Institut de Recherches Internationales Servier),
  • GMA (Global Medical Affairs).

IRIS typically performs phases 1 to 3. GMA performs late development stage studies (some phase 3 and all phase 4 studies).


Source: texts adapted from clinicaltrials.gov


The importance of clinical trial

Designing a clinical trial

The Journey of a clinical trial

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