Clinical Trials

Clinical trials, also called clinical research, are studies that depend on human volunteers to answer specific health questions. Clinical trials help discover treatments that work in people and new ways to improve health. Interventional trials examine whether experimental treatments or new ways of using known therapies are safe and effective. Observational trials assess health issues of large groups of people or populations in natural settings. If you are interested in participating in a clinical trial, talk to your doctor to see if a clinical trial may be an appropriate option in your case.

Clinical drug trials are commonly conducted in phases:

Phase I

Phase I trials are typically the first step in testing the safety and efficacy of a potential drug. Doctors and health researchers are in the process of trying to determine the drug’s effect on the disease and on the patient. Among the things that researchers are trying to understand are safety profile, correct dosage, and any side effects.

Phase II

At this stage, researchers choose a relatively small group of patients to study the effects of the pre-determined dosage. Phase II studies also typically focus on a type of disease.

Phase III

In Phase III testing, researchers compare the effectiveness of the experimental drug against already existing medicines. Frequently, patients are randomly assigned to therapeutic groups to reduce the possibility of researcher bias. Phase III trials can be large, typically recruiting patients from across the country.

For more information about clinical trials, visit http://www.clinicaltrials.gov/ct/info/whatis

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