Clinical trials are research conducted in humans to prove the effects of one or more investigational medicinal products. All investigational medicinal products should go through clinical trial. All medicinal products have to undergo clinical trials to test their efficacy and safety before entering the European Union market.
What is the procedure for clinical trials in Europe?
Clinical trials conducted in the European Economic Area have to comply with European Union clinical trial legislation. Clinical trials conducted outside the EU, but referred to in a clinical trial application within the EU will have to comply with regulatory requirements that are at least equivalent to those applicable in the EU.
Clinical trials are conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following:
- Who is eligible to participate in the trial;
- Details regarding tests, procedures, medications, and dosages;
- The length of the study and information being gathered.
Informed consent is the process of providing potential participants with the key facts about clinical trials before they can decide whether to participate. The process of informed consent then continues throughout the study phases.
How do clinical trials work?
Clinical trials are conducted in “phases.” Each phase has a different purpose which helps researchers answer different questions.
Phase I trials: Researchers test an experimental drug or treatment on a small scale for the first time. The purpose is to evaluate its safety and identify side effects.
Phase II trials: The experimental drug or treatment is administered to a larger group of people to determine its effectiveness and to further evaluate its safety.
Phase III trials: The experimental drug or treatment is administered to large groups of people to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase IV trials: After a drug is approved by the EMA and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use.
At EFA we work to achieve the following policy goals:
- An increased involvement of patients in clinical trials, from setting the research agenda to the conduction of the study;
- Greater transparency for clinical data results;
- Strengthening the protection, safety and privacy of patients taking part in clinical trials.