Current Clinical Studies
- Birth Control (enrolling Fall 2013)
- Vaginal Atrophy Painful Intercourse
- Vaginal atrophy
- IUD Study
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:
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.
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.
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.
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.
Trials may be conducted to determine better dosing guidelines, new formulations, effects on different populations or new indications.
What should I expect?
Before you participate in a study, a detailed description of the study, as well as possible risks and benefits, will be provided in writing in an “Informed Consent Document” and discussed with you. You will be asked to review and sign the Informed Consent Document prior to participating. Your medical history will be reviewed, and you will be given a study related physical exam and laboratory tests.
If you qualify, you will be enrolled in the study. Once enrolled, feel free to discuss your research care with the study physician or research staff members at any time during the course of the study. Information collected during a medical research study may of may not ultimately lead to the investigational drug being approved by the FDA or other regulatory health authorities, and may result in future developments of new drugs.
It is important to:
As a study participant, you will have the right to contact the study’s IRB or EC representative regarding your rights as a research patient. You will also have the right to leave the study at any time.