Training in Clinical Research

Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with the objective of determining safety and efficacy of the new drug.

Clinical Research is Conducted in 4 Phases

Phase I trials
This is the first time the new drug is administered to a small number, around 20-80 healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.

Phase II trials
In this phase, the medicine is administered to a group of approximately 100-300 informed patients to determine its effect and also to check for any unacceptable side effects.

Phase III trials
In this phase, the group is between 1000 and 3000, for the company to use statistics to analyze the results. If the results are favourable, the data is presented to the licensing authorities for a commercial licence.

Phase IV trials
This is a surveillance operation phase after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.