Phase III Clinical studies are extended Clinical studies, which are carried out, as a rule, with the participation of several thousand trial subjects and are maximum similar to real-life clinical practice. The exception is limited Clinical studies of the 3rd phase, the number of patients in which can be 100-500 people.
The objective of Clinical studies
The main objective of Phase 3 Clinical studies is to confirm the data obtained on the safety and efficacy of the drug for different populations of people. The dependence of the drug activity in connection with the age of the trial subjects, the impact of comorbidities, therapeutic benefits, also the maximum and minimum doses are specified. After carrying out these studies, the registration procedure of the drug can be initiated.
There are 2 stages:
- 3a – the period from the beginning of drug testing on the specified range of patients to the provision for marketing authorization.
- 3b – the period from the filing of the application to the final registration of the drug.
The total duration of the first three phases of Clinical studies usually depends on the drug and the usage spectrum. The usual period for prelicensure studies is at least 3 – 4 years.