Clinical Trial Site

If you are interested in participating in a trial as a healthy person or a patient, you can:

• Register for a trial for which we are actively recruiting.

• Join our mailing list for upcoming trials.

Your application for the mailing list or a trial is fully voluntary. You are never obliged to participate in a trial and you can decide to stop your participation in a trial at any time. If you decide not to participate (any longer), this will not in any way affect your possible future treatment or the relationships with your doctor or ITM.

Before a new vaccine or drug is launched on the market, its efficacy and safety must be thoroughly tested. This is a long process. It all starts with preclinical research in the laboratory and tests in animal models. Afterwards, the tests are applied to healthy people and patients in different phases. For each clinical trial, a trial protocol is drawn up, in which various factors are clearly described:

• What is the purpose of the trial?

• Which product is being evaluated? At what dose? Under which administration form?

• What is the medical background of the trial participants?

• Which criteria determine the effectiveness and safety of the product to be evaluated?

• Which procedures (examinations, sampling ...) are scheduled?

• ...

Before a clinical trial can begin, all trial documents must be submitted to an independent ethics committee and the regulatory authority (in Belgium the Federal Agency for Medicines and Health Products, or FAMHP). Following ethical and regulatory approval, healthy individuals and/or patients are invited to participate in the trial on a voluntary basis and with sufficient background information.

When you participate in a trial as a healthy volunteer or a patient, you may receive a vaccination against an infectious disease that you may encounter in the future (e.g., COVID-19, rabies, yellow fever ...) or a therapy with a particular new treatment that turns out to be effective for you. Depending on the trial protocol, there is usually no guarantee that you will receive a specific vaccination or therapy. Also, we cannot guarantee that the vaccine or therapy being studied will actually protect or cure you. Personal benefits may not be achieved, but you will be making a significant contribution to the research of new vaccines, drugs or diagnostics. That way, you have made an impact on the health of others around the world.

When you participate in a trial as a healthy volunteer or patient, you are exposed to a certain risk. The main purpose of clinical trials is to test new vaccines or treatments for which not all side effects or adverse reactions may be known yet. However, before being tested on humans, new vaccines and drugs are first extensively tested in laboratory and animal experiments. Thereafter, a trajectory of different trial phases is set up, in which the safety and effectiveness of the product is always closely monitored. A clinical trial can only start after both an independent ethics committee and the authorised government institutions have approved it.

Moreover, at the Clinical Trial Site, we only participate in trials with products that have been evaluated in humans before.

Before a clinical trial can start, the trial must always be approved by an independent ethics committee and the regulatory authorities of the government. Even after approval, a trial report must be submitted to the ethics committee and the government at least once a year. In addition, the government can organise an inspection at any given moment to check whether all legal requirements have been met.

Check out the overview of past, current and upcoming trials on the website.

If you are interested (and eligible) to take part in a trial, the doctor coordinating the trial will give you detailed information during a consultation. You will also receive an information and consent form with information about the purpose of the trial, the medication, the nature of the tests, samples (blood or other), the planning, and so on. In addition, the doctor will explain what will happen to your personal data and the biological samples.

Participating in a trial may require some extra effort. For example, you may have to come to the CTS at predetermined times. It is also possible that, in the context of the trial, additional examinations or sampling are planned.

Naturally, as a trial participant, you also have certain rights. You decide for yourself, on a voluntary basis, if you want to participate in a trial. You have the right to ask questions about the trial and about what is expected of you. After the consultation with the trial doctor, you do not have to decide immediately whether you will be participating. You are free to discuss your participation with your GP, family or friends first. If you agree to participate, we will request a written confirmation on the information and consent form.

You can always direct your questions to:

• The trial doctor,

• The CTS team,

• The contact person mentioned on the information and consent form

The trial's information and consent form specifies whether you will receive a compensation as a trial participant. In any case, participation in a trial never implies any costs for the participant. All consultations with the doctors and nurses at the CTS, the use of the vaccines or medicines, and the laboratory tests are always free of charge in the context of the trial.

The sponsor of the trial is legally obligated to arrange no-fault liability insurance. This implies that you will always be compensated if you suffer any kind of damage or harm due to your participation in the trial, even if the damage cannot be attributed to any fault of the researchers. However, the insurance does not cover the natural course of your disease, nor the known side effects of your regular treatment or regular research. In the trial information and consent form, you can find the contact details of your trial doctor. You are free to contact him or her if you have suffered any damage as a result of your participation or if you would like to receive more details about the trial insurance.

All information collected in the context of the trial is encrypted and protected by privacy laws and medical confidentiality. Your name, personal details and medical data will never be included in the trial reports or shared with any external parties. In addition to your data, we can also collect biological samples as part of the trial or for possible future research. Your samples can only be used in future research if an independent ethics committee has approved this research. If you do not wish for your biological samples to be kept for later use, you can indicate this on the information and consent form. This has no impact on your further participation in the trial.