Epidermolysis bullosa
1. Research process and clinical trials
The Figure 1 tries to show the different phases in investigation and the order in which they take place. As it is highlighted in the upper grey bar and the temporal line, the investigation process and the clinic trial are things that take quite some time for its development.
When people see a published notice or an article many ask themselves how much time will it take until starting a clinical trial or for said therapy to be available. In order not to give false hope, this process usually takes a long time, many years (minimum 15 years according to data from DEBRA International). It is even possible that said discovery does not continue to the next phases (we will explain the reasons along this chapter).
But we must always look at things from different perspectives. For each failed experiment, each protocol that requires months or years to perfection it, are grains of sand and more knowledge given by the scientific and clinical personnel to advance to new treatments. Or maybe, someday, a cure for EB.
In the process of investigation and development of a drug or therapy there are 4 phases:
- Basic investigation or discovery phase
- Preclinical development (animals)
- Clinical development (humans)
- Authorization and commercialization