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Clinical Research Trials

OB/GYN Specialists of the Palm Beaches currently conducts Phase II, III and IV women’s health trials.

What is a Clinical Research Trial? A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases:

Phase I
Researchers test a new drug or treatment in a small group of people (20-80) for the first time to test its safety, identify the maximum tolerated dose, find a safe dosage range and identify side effects.

Phase II
The drug or treatment is given to a larger group of people (100-300) to see if it is effective, to further evaluate its safety and to gather additional information regarding safe dose range.

Phase III
The drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.

Phase IV
During this phase, investigators are looking for additional information, including the drug or treatment's risks, benefits, and optimal use. This trial may occur after the drug or treatment has been approved for use by the FDA.

Phase IV
Trials may be conducted to determine better dosing guidelines, new formulations, effects on different populations or new indications.

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