What is Clinical Research?
Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the clinical pharmacology (including pharmaco-dynamic and pharmaco-kinetic) or adverse effects with the objective of determining safety and efficacy of the new drugs.
Clinical Research is conducted in 4 phases
Phase 1 Trials:
This is the first phase where, the new drug is administered first time 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 patients body and behaves in the predicted way.
Phase 2 Trials:
In this phase the medicine is administered to a group of approximately 100 – 300 informed patients to determine the effects and also to check for unacceptable side affects.
Phase 3 Trials:
In this phase the group selected is between 1000 – 5000, for the company to use statistics to analyze the results. If the results are favorable, data is presented to licensing authorities for a commercial license.
Phase 4 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.