What is Clinical Research?
Clinical Research is a systematic study of new drugs in human subjects that generates data for the discovery or verification of clinical, pharmacological (including pharmacodynamic and pharmacokinetic) or adverse reactions with a view to determining the safety and efficacy of the new drug.
Phase I trials
This is the first time the new medication has been administered to a limited number of healthy, knowledgeable participants, roughly 20-80, under close supervision of the physician. The goal is to decide whether the new compound is tolerated by the patient’s body and acts in the manner envisaged.
Phase II trials
At this stage, the medicine product 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 step, the community is between 1000 and 5000, so that the organization can use statistics to analyze the results. If the results are favorable, the data shall be submitted to the licensing authorities for a commercial licence.
Phase IV trials
This is the surveillance operation phase after the medicine has been made available to doctors who are starting to prescribe it. Effects are monitored in hundreds of patients to help to identify any unexpected side effects.