Phase II clinical trials

Investigate the safety and efficacy of the drug in larger numbers of patients (100s) with a focus on the effectiveness of the treatment at different doses, and its safety in the target patient population. Usually, when phase II is completed the manufacturer will decide whether the safety and efficacy of the drug in the target patient population warrants further development. The drug will only be taken into phase III development if there is a very good chance of the drug meeting the strict safety and efficacy guidelines stipulated by the regulatory authorities.