CROC-P

What is Clinical Research?

     Drug discovery procedure evolution is now in its revolutionary stage and possesses a very long and rigorous procedure termed as ‘Clinical Trials’, which ensures the safety of the newly discovered drug molecule for the human use.

     A clinical research study tests the effectiveness of an experimental drug. Studies may also test medical devices or new procedures. Medical science is always looking for better solutions to treat diseases. Before a new procedure, device, or drug can be used as a treatment it must be tested for effectiveness and safety. Most likely, every doctor-prescribed medication that you use was first tested in a clinical research study. Clinical trials are key to improving medicine for all patients.

     Research is defined as “Trials that evaluate an investigational drug, biological, or medical device on patients in a strictly, scientifically controlled setting in order to test the safety and efficacy of an experimental entity where it involves controlled use of humans in medical experiments”.

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 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 the effects and also to check for an unacceptable side affects.
Phase III trials: In this phase the group 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 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.