Phase II, III, IV Clinical Trial

There is an opportunity to conduct Phase II, III, IV clinical trial at CDC of NUPh.

Phase II Clinical Trial is the first experience of using the drug in patients with the disease, for the treatment of which it is intended to use this medicine.

The main goal is to demonstrate the clinical effectiveness of the drug during testing on a specific group of patients. In addition, the task of the Phase II is to determine the level of the therapeutic dose of the drug, the dosing schedule, etc.

In the Phase II study, 200 to 600 subjects are usually involved. Sometimes the Phase II CT is divided into phases IIa and IIb, where phase IIa is a clinical trial designed to determine the level of drug safety in the small groups of patients with a disease or syndrome for which the drug is intended to use, diagnostic or prophylactic purposes, and phase IIb includes more extetrnsive baseline clinical trial.

Phase III CT are carefully controlled studies designed to determine the safety and efficacy of the drug under conditions close to those in which it will be used if it is resolved to medical use. This study is conducted involving a large variety of patient groups.

Phase III CT are sometimes divided into phases IIIa and IIIb. Phase IIIa is carried out after the effectiveness of the drug has been proven, but before filing an application for registration with regulatory authorities. Phase IIIb is conducted after applying for registration but before obtaining approval for the drug and its launch into production.

Phase IV CT is carried out after licensing (registration) of the medicinal product. This phase of the trial includes studies conducted to obtain more detailed information on the safety and efficacy of the registered drug within the indications for which it is permitted.

Starting from 2005, a highly qualified team of the CDC conducted 7 Phase II-IV studies.

The quality of all clinical trial performed meets all ICH GCP requirements. Based on the results of one of our studies (Phase II), the FDA registered the investigated medicine and allowed for use.

Useful link:

Training on GCP