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*All required fields must be completed. Please include non-medical questions and correspondence only. If this is an emergency referral, please contact our office directly, Jacksonville 800.237.3846, Daytona Beach 800.555.6590, Lake Mary 877.357.3846. Our regular office hours are 8AM to 5PM Monday through Friday.
Clinical trials are studies in which people volunteer either as healthy participants or those that are suffering from a particular illness to help determine whether a new treatment is safe and effective for use in the general population.
Sometimes the studies include use of a particular test agent or treatment to check its effectiveness on a disease or disease process and sometimes a study can be as simple as gathering demographic information on certain areas of the population to determine trends in the healthcare needs of the general population.
When using a drug that is being tested for its safety and ability to help with certain diseases, there are five steps, or phases, that every clinical trial must go through in order to become FDA approved for use. Each phase is designed to answer a separate research question.
Preclinical this is the initial testing that is done in the lab when a researcher has discovered a new agent or treatment that he feels is worthy of further testing.
Phase 1 this phase tests the initial safety and tolerability (pharmacology) of the test drug or treatment, determines safe dosage ranges and identifies any side effects. Test population is generally 20 – 80 people.
Phase 2 this phase tests the effectiveness, called therapeutic exploration, dose response and any further safety concerns. Test population is between 100 – 300 people.
Phase 3 this phase confirms the effectiveness (therapeutic exploration) monitors side effects, compares to commonly used treatments and collection of information that will allow the drug or treatment to be used safely. Test population is usually between 1,000 – 5,000 people.
Phase 4 this phase concerns itself with post marketing (therapeutic use), effectiveness in the general population and optimizing drug use. This test population is unlimited since the drug or treatment is now in use by the general population.
Participating in a clinical trial is always voluntary. There is no coercion used when offering a trial to a patient, and you can leave any clinical trial at any time for any reason.
Participation is never a determination of treatment in any clinic and you cannot be denied healthcare for leaving a clinical trial early. Most clinical trials are sponsored by the National Institutes of Health — a federally funded organization. Other trials are sponsored by pharmaceutical and biotech companies that develop the drug or treatment.
For more information about clinical trials or if you should have any questions, please feel free to contact us.
If you want to see a list of clinical trials, go to Clinicaltrials.gov, a site sponsored by the National Institutes of Health.