Clinical trials are research studies on human patients aimed to prove safety and efficacy in an experimental therapy or treatment. Before clinical trials on investigational drugs involve people, several preclinical tests are carried out in laboratory and/or on animals to evaluate:
- Whether the drug is safe and effective
- Which is the best way of administration
- How does it works in the body
- What are the side effects.
A clinical trial is a research study that allows to collect the information needed to define if an investigational drug can be used as a new potential treatment in people, as well as to evaluate the risks and benefits of the study drug. Usually, three phases are required to develop a new treatment. Each trial phase has a different purpose and helps answer different questions:
- Phase 1: A study drug is tested in a small group of people, often in volunteers without disease for the first time to evaluate its safety and to determine a safe dose to be administered.
- Phase 2: The study drug is tested in a larger group of people to confirm its safety, as well as to evaluate efficacy and possible side effects.
- Phase 3: The study drug is tested in a larger group and over a longer time period to confirm its efficacy and to detect less common or rare side effects.
For more information about clinical trials in general, please see ClinicalTrials.gov or Clinical Trial Register EU.
If you are interested in participating in a Italfarmaco clinical trial and would like to contact someone, please email firstname.lastname@example.org. If you are already participating in a Italfarmaco clinical trial and wish to report a problem with the study drug or side effect(s), please contact your study doctor as soon as possible.