About Clinical Trials
Our current treatment options include the following conditions:
- Celiac Disease
- Crohn's Disease
- Eosinophilic Esophagitis (EoE)
- Gastroesophageal Reflux Disease (GERD)
- Hemochromatosis
- Hepatitis C Virus (HCV)
- Inflammatory Bowel Disease (IBD)
- Nonalcoholic Steatohepatitis (NASH)
- Pouchitis
- Primary Biliary
- Ulcerative Colitis
What Is A Clinical Trial
Clinical trials are medical research studies performed on people to determine whether new medical approaches, treatments, therapies, or devices are safe and effective. Doctors use clinical trials to learn how diseases start and progress, find new ways to improve health care, develop new therapies and preventive measures, and monitor changes in treatments over time. Clinical trials are the stepping-stones to bringing a drug or other therapy to market. Clinical trials demonstrate that a new drug is safe for people to utilize.
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 tests 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.
Why participate in a Clinical trial?
At GI Alliance, patients who qualify and enroll in a clinical trial receive personalized care from our leading-edge staff of digestive disease experts. Each clinical trial has specific qualification criteria. GI Alliance clinical research staff will discuss specific requirements with every applicant. Those who qualify receive cutting-edge medications and treatments and highly personalized care tailored to their lifestyle, typically at no cost. As a result, clinical trial participants often receive more frequent and individualized treatments than are likely obtained elsewhere.
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.