What is a clinical study?What is a clinical study?
A clinical study is a study with patients and/or healthy volunteers that is carried out to evaluate whether a new treatment is safe and if it works. Clinical studies are performed in order to test the effectiveness of medications or of combinations of various treatments.
Scientific research and clinical studies are essential for both developing and optimising medical treatments and techniques. No new medication or new treatment is used before extensive studies have shown that this new product or new treatment is effective and safe.
No medical progress is without your help
Focus on medicationFocus on medication
Medications that become available to patients are the result of a long and complex process (fourteen years, on average). They can be developed in an academic research centre or in a pharmaceutical company. At the end of this process, approximately one investigated medicinal product in ten is granted marketing authorisation.
The development of a medication takes place over several steps.
In each step, specific questions are asked and aspects are assessed.
- Before a medicinal product is brought to market, it is analysed in non-clinical or pre-clinical studies to determine its mode of action and toxicity.
- It is then tested on animals.
- When, after all these non-clinical studies, the balance of benefits and risks of the medicinal product is positive, clinical trials may be carried out on humans. These studies test the medication’s efficacy, examine the effects and compare them with existing drugs or with a placebo and identify side effects.
If you qualify for a clinical study, your physician will give you more information about this. This way, you can decide whether to participate on the basis of all the available information.
Your participation is voluntary, and you can stop whenever you wish. You do not have to give an explanation for this. And it will not influence your subsequent treatment or relationship with your physician.
Clinical studies in four phasesClinical studies in four phases
The development of a new product or of a new treatment is divided into four phases.
The safety and effectiveness of the new product is tested on a small group of healthy volunteers in order to discover the general effects (e.g. absorption in the blood) and whether there are any immediate side effects.
The test medication is administered to a small group of healthy volunteers in order to:
• determine the optimal dosing
• to research the tolerance
• to research any potential toxicity
The test medication is administered to a hundred patients in order to:
• test the effectiveness
• to list the side effects
The medication is administered to an even larger number of patients (often thousands) in order to:
• confirm the balance between benefits and risks
• to study the effects and to compare them to existing medications or a placebo
The medication is brought to market and used by an even more heterogeneous group of patients. Doing so enables the side effects to be closely followed.
All phases of a clinical trial take place under the supervision of a physician researcher. At the Maria Middelares General Hospital, we focus primarily on phase II-IV studies.
Current clinical studiesCurrent clinical studies
You will find here an overview of departments that have ongoing clinical studies at the Clinical Research Centre of the Maria Middelares General Hospital:
- General medicine
- Anaesthesia / Intensive Care / Pain Centre
- Cardiac Surgery
- Digestive Centre
- Integrated Cancer Centre Ghent
- Paediatric Allergy Centre
- Ear, nose, and throat diseases
- Orthopaedics and Traumatology
- Urology Centre