What is Clinical Research?

Clinical research is the study and compilation of information on medications and devices to provide evidence that they are both safe and beneficial. Research studies are organized into four phases.

Phase I

After an investigational drug has passed numerous animal and laboratory tests for safety and beneficial effect, the drug begins Phase I. During Phase I, the medication is given to patients to determine the safety of the medication, identify the maximum tolerated dose, find a safe dose range and identify side effects.

Phase II

During Phase II, the medication is given to a larger group of patients (100-300) to see if it is effective, to further evaluate its safety and to gather additional information regarding the safe dose range. Once the most effective dose has been identified, the drug enters the next phase.

Phase III

In Phase III, the medication is given to large groups of patients (1,000-3,000) to confirm if it is truly effective and safe in treating a specific disease, monitor side effects, compare it to commonly used treatments and collect information that will allow the medication to be used safely. Once the drug successfully passes Phase III, it will usually be approved by the FDA for use by all physicians in treating that disease.

Phase IV

Phase IV trials are usually conducted for marketing purposes after the drug has been approved by the FDA. Research activities are closely monitored by regulatory agencies which have rigid guidelines for the process by which all research related activities are conducted. Regulatory agencies are charged with assuring that physicians comply with ethical guidelines to ensure that each patient’s rights are protected. Currently, over 41,000 clinical trials are underway around the world.

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