What is a clinical trial?
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.
Please note that there is a difference between a clinical trial and a clinical study. A clinical study refers to any research in relation to humans investigating one or more medicinal products with the objective of ascertaining the safety and/or efficacy of those medicinal products. A clinical trial is an interventional clinical study, which means that administration of the medicinal product(s) in the context of the study cannot be considered normal clinical practice.
What sets a clinical trial apart is its framework—a pre-determined therapeutic strategy outside normal clinical practice, like administering investigational medicines or including additional diagnostic or monitoring procedures.
More information to determine whether a clinical study is a clinical trial can be found in the link to the European Regulation in the paragraph Legislation and submission procedures below.
- Various steps
- Participating in a clinical trial
- Benefits and risks
- Rights and obligations
- Role of the FAMHP
Information on applications and clinical trials
To better support patients and healthcare professionals in finding suitable clinical trials, the European Medicines Agency (EMA) offers both the public CTIS database and the Clinical Trial Map. These tools provide a clear overview of ongoing studies in the EU and enable targeted searches based on criteria such as condition, participant type or location. In addition, Belgium offers an interactive dashboard, which is updated quarterly and provides an overview of all initial CTR submissions for which a decision has been issued in Belgium since the regulations came into force. Together, these reliable sources of information increase transparency around clinical research and help patients and professionals find their way to relevant clinical trials more quickly.
- Clinical trial database
- Dashboard clinical trials
Legislation and submission procedures
The Clinical Trials Regulation (CTR) brings together a number of key concepts and procedures that govern the conduct of clinical trials in the European Union. Below, we outline several key topics that have a direct impact on the assessment, organisation and conduct of clinical trials: the timelines applicable under the CTR, the provisions of Regulation 536/2014, the role of the Safety Assessing Member State (saMS), and the specific requirements for clinical trials involving genetically modified medicinal products or those with decentralised elements.
- Applied timelines
- European Regulation 536/2014
- Safety Assessing Memeber State (saMS)
- Clinical trials with genetically modified medicinal products
- Clinical trials with decentralised elements