Clinical trials

Clinical Trials conducted in the European Economic Area have to comply with the EUs Clinical Trials Regulation (536/2014), which aims to provide more transparency on clinical trials data. Accordingly, 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.

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.

All clinical trials are conducted according to a plan. These protocols are carefully designed to safeguard the participants’ health and answer specific research questions.

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. 

In anticipation of a fully functional EU clinical trials portal and database, the entry into application of the Regulation is currently estimated to occur in 2019.