Gastro One is proud to have a dedicated clinical research department with over 10 years of experience in performing clinical trials. Most trials test the safety and efficacy of new investigational medicines. Our trials usually involve treatments for Crohn’s disease, ulcerative colitis, fatty liver, cirrhosis, hepatitis C, gastroesophageal reflux disease and irritable bowel syndrome.
Our research center has a full-time staff of fully trained clinical research coordinators and nurses who participate in continuing education programs and maintain certification with the Association of Clinical Research Professionals. Our center is also supervised by board-certified gastroenterologists with training, expertise and credentialing in clinical research. Our research facility is located at our Germantown Endoscopy Center.
Why volunteer for a trial?
Participation in a clinical study is a voluntary process. Clinical research is essential for discovering new information and new treatments for many medical conditions. Taking part in a trial allows you to play a role in the discovery of treatments and cures for your medical condition. In addition to potentially helping others suffering from the disease state, participating in a trial gives volunteers the opportunity to access investigational treatments before they are widely available.
What to expect as a study volunteer?
Informed consent is obtained at the beginning of any clinical trial. You will be able to review the consent form, discuss it with the study team, and learn why the study is being done and what to expect from the trial. You can ask any questions about the study or the study- related testing and procedures, including questions about parts of the consent form that you did not understand. You can also ask questions about possible side effects from the actual treatment proposed. If you decide to participate in the trial, you will need to sign the consent form. Even after signing the consent form, you can still change your mind and stop participating in the study at any time.
After you agree to participate, you will need to undergo a screening evaluation to ensure that you are actually eligible for the study itself. This evaluation usually consists of a detailed review of your medical history, a complete physical examination and various laboratory tests. Some studies require X-ray or endoscopic testing as part of the initial evaluation. The clinical trial visits start after you are found to be eligible.
Is it safe to participate?
Patient safety is always a priority during clinical trials. All trials involve some form of risk, as is the case with almost any medical or therapeutic intervention. The risks during clinical trials are minimized as much as possible with the following steps: All trials are performed following discussion and consultation with the Food and Drug Administration. Investigational drugs undergo rigorous pre-clinical laboratory, toxicologic and animal testing before consideration for clinical studies. Studies also have to be approved and monitored by an independent ethics committee called an Institutional Review Board. Your health will also be closely monitored during the study to ensure your safety and to monitor your progress.
Do I have to pay for any part of the trial?
Clinical studies are usually funded by medical societies, the federal government or private industries. The medical care, including the cost of the testing, visits and study medication, is provided for free during most of our studies. Some studies also pay the volunteers a small fee for their participation.
How do I get additional information about studies available at Gastro One?
Additional resources have been supplied at the bottom of the page.
For additional questions, please contact:
www.clinicaltrials.gov: Provides information about clinical research and about clinical trials related to various diseases. It also has a registry of trials, and patients can search for studies based on illness or location.
www.centerwatch.com: Has a national and international listing of clinical trials in all therapeutic areas.
www.fda.gov/forpatients/clinicaltrials: Plain-language description of clinical trials and why people volunteer to participate. Also offers interactive patient education tutorial on clinical trials.
www.crohnscolitisfoundation.org/resources/clinical-trials: Provides additional information on trials available for Crohn’s disease and ulcerative colitis.