Table 2.

Clinical trial phases in drug commercialization and motor rehabilitation

Phase	Drug commercialization	Studies on rehabilitation	Purpose
Phase I	Checking for safety (on 10–20 healthy volunteers)	Consideration-of-concept studies (on 6–12 patients)	To test concepts and related safety on animals or on a small group of patients
Phase II	Checking for efficacy (on about 200 patients)	Development of Concept Trials (>15 patients)	To standardize the new intervention and add a control group, randomization, and masked outcomes. To establish the best dose of therapy. To assess sample size
Phase III	Confirmation of findings in large patient population (>1000 patients for detecting rare side effects)	Demonstration of Concept Trials (on a sample with a properly computed size)	To prove effectiveness and safety of intervention
Phase IV	Testing long-term safety (real life patients)	Proof of concept (multicenter randomized clinical trials)	To establish generalizable efficacy and safety