Epidermolysis bullosa

Participating in clinical trials offers the opportunity of helping the scientific community to develop new treatments for other people in the future. At the same time, offers the volunteering person the possibility of getting a new treatment that might help improve their quality of life.

And what happens once a clinical trial is finished? Once the clinical trial ends, the clinical and research team analyses the data. The results have to be shared with the scientific community and the population. The FDA is the organization responsible in the USA to ensure the safety and efficacy of medicines. It requires that the results of clinical trials are made available to the public within one year after the end of the trial. The AEMPS does the same in Spain. However, enforcing this rule is complicated and it is often difficult to obtain information on the results of some clinical trials that have already been completed.

The research team will decide which steps to take once they have the results. If it has not been able to prove the treatment is effective or safe, there are two options: either we keep investigating on said compound, or we start anew. 98% of the drugs or treatments tested in clinical trials do not reach the authorization phase. However, the information collected in the “failed” studies is very useful for the scientific and clinic community. They are part of the scientific development.

Right at this moment, around the world there are over 100 clinical trials registered destined to people with EB. In the web of reference, www.clinicaltrials.gov, we can consult the details of each clinical trial, inclusion and exclusion criteria, etc. We can also see in a map the number of clinical trials by country. On a global level, USA keeps being the leader, and in Europe France in the top in the ranking of trials in EB, followed by Austria, United Kingdom, Germany and Spain, with 7 trials registered.