About Clinical Trails
At Gastroenterology Associates of Florida, our clinical trial treatment options include the following conditions:
What Is A Clinical Trial
Clinical trials are research studies that evaluate the safety and effectiveness of new approaches to treating disease. They are conducted in phases, with each phase serving a different purpose. Each phase may have certain requirements and differ in the length of time. Most drugs or therapies that enter clinical trials need to go through multiple phases before they’re approved by regulatory agencies like the FDA and allowed on the market.
What are the four phases of clinical trials?
Clinical trials advance through four phases to test a treatment, find the appropriate dosage and look for side effects.
Phase 1: Typically involves a small number of healthy volunteers and is designed to test safety and tolerability.
Phase 2: Involves studies with more participants to measure the drug's effectiveness. Additional dosing information may be obtained in Phase 2.
Phase 3: Researchers conduct final efficacy studies in large groups of patients or very large groups of participants with a specific disease the trial drug intends to impact. In addition, they will compare results among those taking the experimental drug with results from those who are taking a placebo. Intervention testing may also be used in combination with other medications or treatments during Phase 3. If, after all these tests prove safe and effective, the FDA approves it for clinical use.
Phase 4: Researchers perform tests to monitor the drug's effectiveness, and safety in a large, diverse population after the FDA has approved a drug or device. These trials also help doctors learn and track any side effects with long-term use.
Preclinical
Several Years
Phase 1
Months
Phase 2
Months to Years
Phase 3
Years to Decades
Phase 4
Ongoing
Why Partcipate in a Clinical Trial?
At Gastroenterology Associates of Florida, the health of our patients is our most important concern. With this in mind, we offer access to a wide range of cutting-edge clinical trials for gastrointestinal disorders. Our leading GI specialists are well-versed in the latest treatment options for complex GI diseases and work closely with each individual patient to choose the optimum therapy for them — whether it be an FDA-approved medication or an investigational drug.
Common reasons to participate in a clinical trial include:
- All other treatment options have failed, and no further treatment options are readily available
- To obtain access to advanced treatments and protocols for their disease before the protocol becomes available to the general public
- To help researchers learn more about the impact of the trial protocol to benefit others
- To obtain access to medications and treatments required for their condition, free of cost throughout the trial