A medicine that is available to patients is the result of a long and complex process (14 years on average), whether it is developed in an academic research centre or in a pharmaceutical company. At the end of this process, approximately one medicine in ten tested receives a marketing authorization.
The development of a medicine involves several steps. In each one of them, specific questions are asked and specific aspects are assessed. Before a medicine is marketed, it is analysed through non-clinical or preclinical research to determine its mechanism of action and its toxicity. It is then tested on animals as well. If the balance between the benefits and the risks of the medicinal product turns out positive, after all these non-clinical studies have been conducted, clinical trials can be carried out on human volunteers.
The investigational drug is administered to a small number of healthy volunteers to:
• determine the optimal dose, • investigate tolerance, • investigate possible toxicity.
The investigational drug is administered to about 100 patients in order to:
• test the efficacy, • list the side effects.
The investigational drug is administered to an even larger number of patients (often thousands) in order to:
• confirm the balance between benefits and risks, • investigate the effects and compare them against existing drugs or against a placebo.
The investigational 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 are carried out under the supervision of a clinical investigator.
And what happens then? Once the medicinal product has been marketed, suspected adverse reactions may be reported to the FAMHP(link is external). The analysis of side effects allows the FAMHP to assess the safety profile of the medicinal products and take action if necessary.
Drug manufacturers may also organise trials to investigate long-term safety and efficacy.
The efficacy of the drug 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 standing in 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 global solidarity because the knowledge and experience gained during these trials is shared at the international level. It means that medicine also evolves beyond a country's borders.
Since certain clinical trials give participating patients access to the latest treatments before they are available on the market, the doctor treating the patient plays a key role in informing them of the different possible scenarios (placebo or drug). For example, trial participants will have access to the latest scientific advances. Sometimes, it concerns a new chance of a cure or an increase in quality of life.
Since a clinical trial is designed to answer a question about the investigational drug itself, there is no guarantee yet that this drug will be effective. What is more, depending on the type of clinical trial, there is no guarantee that you will receive the new drug that is being investigated. You are just as likely to be given a placebo and therefore not experience the benefits during or after the clinical trial.
As the treatment is experimental, clinical trial participants may also experience unexpected side effects. Even before the start of the trial, measures are taken to prevent and address identified potential risks. Clinical trials are also closely monitored to detect and prevent these side effects as soon as possible. All participants undergo a specific medical follow-up.
In accordance with the Belgian Law of 7 May 2004 on experiments with human subjects (FR)(link is external), the organiser (also called the sponsor) of a clinical trial is required to take out "no-fault" insurance. Any harm suffered (directly or indirectly) by participants as a result of the clinical trial will always be compensated through this insurance, even if the liable clinical investigator was not at fault.
As a participant, you have the right:
• to participate voluntarily, without coercion or consequences if you do not participate; • to leave the trial at any time; • to receive treatment with the drug under investigation free of charge, and usually to medical examinations free of charge in the context of the clinical trial; • to reimbursement of any expenses, which is evaluated by the ethics committees and serves as compensation for expenses incurred and for the time spent participating in the trial; the reimbursement of expenses is not determined on the basis of potential risk; • to all the information necessary to give your consent before any procedure; • to clear and understandable answers to your questions; • to be informed immediately, even after the start of the trial, in the event of new data becoming available that could have an impact on your decision to participate; • to care that is administered in complete safety, while respecting your beliefs; • to confidential and anonymous treatment of your data; • to insurance paid for by the sponsor of the trial.
As a participant, you commit:
• to provide truthful and complete information about your health status and medical history and any treatments you have received; • to comply with the clinical trial protocol and to cooperate with medical personnel; • to attend appointments and additional evaluations, which may be very detailed.
The medical team at the research centre plays an important role in supporting, monitoring and informing participants. This role does not cease to exist when the trial ends.
The clinical investigator is required to explain all aspects of the trial as fully and comprehensibly as possible. This enables you as a potential participant to have with all the information available to decide whether to participate. This will be recorded in a document that you are required to sign as a trial participant. This informed consent describes in an understandable way how the trial will proceed and the process you will follow as a participant. This document also describes your rights and obligations as a participant.
The organiser of a trial must also have "no fault" insurance in place. This means that you as a participant are covered by insurance even if the investigator was not at fault.
Within Europe, Belgium is among the countries that conduct the most clinical trials per capita. Belgium's network of academic research centres and university hospitals, and the pharmaceutical industry have scientific expertise unlike anywhere else. The competent authorities work continuously with healthcare professionals to support and further develop this leading position in Europe.
As the competent authority for medicinal products, the FAMHP supports innovation and development both in the academic sector and in the pharmaceutical industry in Belgium. This allows patients to have access to new medicines more quickly. Experts at the FAMHP evaluate the quality and safety of experimental drugs used in clinical trials. The FAMHP guarantees you appropriate protection during your participation in a clinical trial.
In collaboration with the ethics committees, the FAMHP verifies whether adequate protection is provided by the sponsor to each clinical trial participant.
The FAMHP is also responsible for inspection of the clinical trial throughout the process and ensuring compliance with good clinical practice.
The FAMHP has created an online database to hold information on all clinical trials in Belgium approved by the agency and that have not yet been completed. This database enables both healthcare professionals and patients to consult the recruitment criteria for clinical trials in Belgium.
The clinical trials database(link is external) developed by the FAMHP allows healthcare professionals and patients to search for clinical trials using five different criteria:
- a word from the title of the clinical trial, - the disease or condition being studied, - the type of participants being sought (healthy volunteer or patient), - the age of participants, - the number in the (European Clinical Trials Database (EudraCT).
Doctors, for example, can use the information from the clinical trials database to provide guidance to patients wishing to participate in a clinical trial in order to help find one that is most appropriate for them.