About Clinical Trials

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 treatment changes over time. Clinical trials are the stepping-stones to market a drug or other therapy.

Washington Gastroenterology is actively involved in clinical research. Research studies are designed to find better ways to diagnose, prevent or treat diseases and medical conditions. We are focused on studies involving individuals with Crohn’s Disease, Diverticulitis, GERD, Hepatitis B, Hepatitis C, Irritable Bowel Syndrome and Ulcerative Colitis. Currently we offer the following:

  • Celiac Disease
  • Crohn’s Disease
  • Gastroesophageal Reflux Disease (GERD)
  • Pouchitis
  • Colon Cancer
  • Ulcerative Colitis
Find a Clinical Trial

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

Designed to test safety and tolerability, Phase 1 typically involves a small number of healthy volunteers.

Phase 2

More participants are involved in Phase 2 to measure the drug’s effectiveness. Additional dosing information may be obtained.

Phase 3 

Studies conducted during Phase 3 of a clinical trial will involve large groups of patients or very large groups of participants with a specific disease the trial drug intends to impact. Researchers also compare results among those taking the experimental drug with results from those who are taking a placebo. Drug 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

During Phase 4 clinical trials, researchers test the drug or medical device’s effectiveness, safety, and side effects after it has been approved by the FDA. In Phase 4 studies, doctors monitor how people use the drug long-term.

Stages of Clinical Trials

Preclinical

Several Years

Phase 1

Months

Phase 2

Months to Years

Phase 3

Years to Decades

Phase 4

Ongoing

Preclinical

Several Years

Phase 1

Months

Phase 2

Months to Years

Phase 3

Years to Decades

Phase 4

Ongoing

Why Participate in a Clinical Trial?

Clinical trials are a vital part of the research process, helping scientists to find new, better ways to treat patients. Metropolitan Gastroenterology Associates is proud to offer clinical trial participants personalized care, cutting-edge medications and treatments, and highly individualized care tailored to their lifestyle at no cost—resulting in more frequent and individualized treatments than are likely obtained elsewhere.

Common reasons to participate in a clinical trial include:

  • All other treatment options have been exhausted to no avail, 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.