The execution of clinical studies is indispensible and legally prescribed for the research and development of new medications and therapies. The studies should offer conclusions as to whether this new medication or therapy can effectively treat illnesses, if its application is safe and whether or not it has the potential to improve the patient's quality of life.
Clinical studies are subject to very strict laws and regulations. They are carefully monitored by the regulatory and advisory authorities of the respective states, the ethics committees and the institutions or hospitals in which the studies are executed.
There are different so-called clinical phases (I-IV) within clinical studies; their division is based on the progress of the medication’s development. Before an active agent or product candidate can even be permitted to participate in clinical phase I, it must have already been subject to years of comprehensive, pre-clinical studies.
Investigation of the safety and tolerability of the medication for healthy subjects and/or patients (also known as "first-in-man")
Investigation of the safety, tolerability and efficacy of the medication for patients; inspection of the therapy concept (“proof of concept”, phase IIa) and the ideal dosage (“dose finding”, phase IIb)
Proof of efficacy and comparison with standard therapy (if available); large patient groups (at least 200 patients) are required in order to be able to make a statistically significant statement; if a therapeutic benefit is proven, a market approval can be applied for by the regulatory authorities
Investigation of the already marketed medications in regards to the possible side effects of the medication