Questions about participation studies
For all your general questions regarding clinical trials, please refer to the government website (FAGG = Federal Agency for Medicines and Health Products) and their brochure.
Of course you can always contact us in case of specific questions and/or concerns.
A drug available to patients is the result of a long and complex process (14 years on average), whether it is developed in an academic research center or in a pharmaceutical company. At the end of this process, approximately one investigated drug out of ten receives a marketing authorization.
The development of a drug involves several steps. In each step, specific questions are asked and aspects are assessed.
Before a drug reaches the market, it is analyzed through nonclinical or preclinical studies to determine its mechanism of action and toxicity. It is then further tested on animals. When, after all these non-clinical studies, the balance of benefits and risks of the drug turns out to be positive, clinical trials can be conducted on humans.
The test drug is administered to a small number of healthy volunteers to:
determine the optimal dosage,
examine any toxicity.
The test drug is administered to a hundred or so patients to:
list side effects.
The test drug is administered to an even larger number of patients (often thousands) to:
confirm the balance of benefits and risks,
examine the effects and compare them with existing drugs or with a placebo.
The test drug is marketed and used by an even more heterogeneous group of patients. This allows for close monitoring of side effects.
All phases of a clinical trial occur under the supervision of a physician-investigator.
Once the medicine is marketed, any adverse effects can be reported to the FAMHP. The analysis of side effects allows the FAMHP to assess the safety profile of the medicines and take any necessary measures.
Drug manufacturers may also organize trials on long-term safety and efficacy.
The effectiveness of the medicine may also be evaluated in populations other than those initially studied or in other indications.
By participating in a clinical trial, you are first and foremost showing solidarity with the generations of today and tomorrow. A gesture of which you can be proud and for which you will certainly be thanked.
Participating in a clinical trial is an important act of solidarity on a global level because the knowledge and experience gained during these trials is shared on an international level. This way, medicine evolves beyond the borders of a country.
Since certain clinical trials give participating patients access to the latest treatments before they are available on the market, the attending physician plays a key role in informing the patient about the different possible scenarios (placebo or drug). Thus, trial participants will have access to the latest scientific advances. Sometimes it involves a new chance for a cure or an increase in quality of life.
Since a clinical trial is designed to answer a question about the test drug itself, there is no guarantee yet that this drug will be effective. Moreover, depending on the type of clinical trial, there is no guarantee that you will be administered the new drug being studied. You may as well receive a placebo and therefore not experience the benefits during or after the clinical trial.
Because the treatment is experimental, unexpected side effects may also occur in clinical trial participants. However, measures are taken even before the start of the trial to prevent and remedy identified potential risks. Clinical trials are also closely monitored to detect and prevent these side effects as soon as possible. Each participant is subject to specific medical follow-up.
According to the law of May 7, 2004 on experiments on the human person, the organizer (also called sponsor) of a clinical trial is obliged to take out "no fault" insurance. Any damage that the participants/participants suffer (directly or indirectly) as a result of the clinical trial is always compensated through this insurance, even if the liable doctor was not at fault.
Your rights and obligations
As a participant/participant, you have the right to:
- To participate voluntarily, without coercion or consequences if you do not participate;
- To leave the trial at any time;
- on free treatment with the drug under investigation, and usually on free medical examinations in the context of the clinical trial;
- on a possible expense allowance that is evaluated by the ethics committees and compensates for expenses incurred and time spent participating in the trial. The expense allowance will not be determined according to potential risk;
- on all information necessary to give your consent prior to any procedure;
- on clear and understandable answers to your questions;
- to be informed immediately, even after the start of the trial, in case there is new data that may impact the decision to participate;
- on concerns administered in safety, respecting your beliefs;
- on confidential and anonymous treatment of your information;
- on insurance paid for by the sponsor of the trial.
As a participant/participant, you commit yourself:
- To provide truthful and complete information about your health condition and medical history and any treatments you received;
- To comply with clinical trial protocol and cooperate with medical staff;
The medical team at the research center plays an important role in supporting, following up and informing the participant. This role does not stop when the trial is over.
The physician-investigator should explain all aspects of the trial in as understandable and complete a manner as possible. This allows you as a potential participant to decide to participate with all the information available. This is recorded in a document that you as a trial participant must sign. This informed consent describes in a comprehensible way how the trial will proceed and what route you will take as a participant. This document also describes your rights and obligations as a participant.
The organizer of a trial must also take out "no fault" insurance. This means that you as a participant are insured even if the doctor did not make a mistake.