Clinical Trial Centre

This is a long process. It all starts with pre-clinical research in the laboratory and tests in animal models. After that, the tests are applied to healthy persons 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 planned?

• ...

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.

You will also receive an information and consent form with information about the purpose of the trial, the medication, the nature of the tests and samples (blood or other) that are scheduled, 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 CTC at predetermined times. It is also possible that, in the context of the trial, additional examinations or sampling are planned.

You can always direct your questions to:

• The trial doctor,

• The CTC team,

• The contact person mentioned on the information and consent form.

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.

• Register for a trial we are actively recruiting for.

• Register for our waiting list for upcoming trials.

The application for the database or for a trial is fully voluntary. You are never under any obligation to participate in a trial or to start or continue a trial after application. If you decide not to participate (any longer) in a trial, this will not in any way affect your possible future treatment or the relationships with your doctor or ITM.

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. This can have a global effect on improving the health of others.

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 CTC, we only participate in trials with products that have been evaluated in humans before.

In any case, participation in a trial never implies any costs for participants. All consultations with the doctors and nurses at the CTC, the use of the vaccines or medicines and the laboratory tests are always free of charge in the context of the trial.

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 like more details about the trial insurance.

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.

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.

Overview of our clinical trials