CLINICAL TRIAL-PHASES

CLINICAL RESEARCH

      As per the Guideline of Clinical Practice (GCP) a clinical trial is a research study on human subjects intended to discover or verify the clinical, pharmacological, and also pharmacodynamic effects of an investigational product and to find out any adverse reaction or adverse events of an investigational product and also to study about pharmacology i. e. absorption, distribution, mechanism and excretion of an investigational product with the object of ascertaining its safety and efficacy..   

Clinical Trial

      The total process of bringing a new chemical molecule from laboratory to get the approval of marketing is tedious and more expensive. But it has been found that the success rate of new molecule development is very low. It is found that one out of very 10,000 molecules has been found to treat disease. Before clinical research of the new molecule on human body, this study is to be tested on animal to ensure about toxicological and pharmacological effects of new chemical molecule which helps to select the dose is to be given and proper guidance to the clinicians.

      The clinical testing of new chemical molecule consists of four phases.

Phase I-  Researchers test an experimental molecule to determine a safe dosage range and identify side effects and is to be done in a small group of healthy human volunteers (20-100).

Phase II-  The experimental study of new chemical entity is given to a larger group of healthy volunteer (100-300) to find out its efficacy whether it is effective or not and also to evaluate its safety.

Phase III- The molecule is tested in a large group of patients (1,000-3,000) to confirm its effectiveness, monitor the adverse events or effects, compare it to commonly used in treatments and to make ensure about the new molecule is to be used safely.

Phase IV- Post marketing trial is needed to ascertain the information about the drug's risks, benefits and optimal use. Actually this study is to be done to compare this experimental molecule with another drugs already in the market.