Large-scale inclusion of patients (hundreds or thousands), usually international multisites collaborative trials that aim to objectively establish the medication’s efficacy,
indications, and interactions. Thus, this phase of trial often requires the highest
amount of money, manpower and resources. Involving larger numbers of patients (ie, hundreds or thousands), Phase III trials are usually international, multicenter, collaborative trials that aim to objectively establish the medication’s efficacy, indications and interactions. Thus, Phase III trials often require the largest amount of financial, manpower and other resources. Medications that have obtained satisfactory results after completion of the Phase III trial can apply for formal marketing with national regulatory authorities.