Gastroenterology Specialties, PC is a progressive organization involved in Clinical Research since 1990. Our strong commitment to Clinical Research enables us to serve our Research Study Volunteers in a variety of areas:

Treatment of Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis)
Treatment of Irritable Bowel Syndrome
Treatment of Liver Disease with emphasis on Hepatitis C
Treatment of Gastroesophageal Reflux Disease
Comparison of Colonoscopy Preparations

Our Study Coordinators provide years of experience in Gastroenterology as well as Clinical Research. In order to reach our objective of quality research, we follow the Food and Drug Administration Information Sheets and the Good Clinical Practice guidelines. Due to the complexity and constant evolving nature of Clinical Research, our staff training is an ongoing priority.

WHY DO PEOPLE PARTICIPATE IN RESEARCH STUDIES?

Volunteers who participate in Research Studies may receive study-related procedures such as Colonoscopies, Upper Endoscopies, Physical Exams, Laboratory/blood testing, EKG’s, Chest X-Rays, and Study Drug all without charge. One of the major reasons why volunteers participate in Research Studies, however, is the opportunity to discuss their health issues with trained health professionals on a one-to-one basis. Study volunteers also realize the importance of their participation in the research and development of investigational medications/drugs that will lead to safer and more effective treatments for Gastrointestinal Diseases.

HOW WOULD I BENEFIT FROM PARTICIPATION IN A RESEARCH STUDY?

You may want to participate in a Research Study because you are suffering from a disease for which a good treatment does not currently exist, or you may be hoping to improve on the medical treatment that you are currently receiving. You need to know that many of our Research Studies involve the use of drugs that have yet to be placed on the market, and are therefore considered Investigational. Many studies compare the “study drug” with an “inactive” comparator or “placebo”. Therefore, volunteers may not be on active treatment during their involvement with the Research Study. Whether you receive the placebo or the investigational drug, the level of medical attention and care that you receive is the same. Elaborate safety monitoring procedures are built into our Research Study Protocols, which include medical evaluations, physical exams and laboratory (blood) testing. Because of these safety procedures, any change in the volunteer’s medical condition is easily detected and appropriate evaluation and treatment adjustments will occur. Our Research Department works closely with the Study Volunteer’s Primary Care Physician to coordinate the volunteer’s health care. Your safety is the number one priority in a Research Study.

HOW DO I PARTICIPATE IN A RESEARCH STUDY?

You must first quality for a Research Study by having a medical condition that requires a treatment that we are currently studying. Many times, our physicians here at Gastroenterology Specialties will recommend you for one of our studies during a routine office call or procedure appointment.
You must meet certain criteria for the Research Study (inclusion criteria) and must not have any of the conditions that are not allowed by the Study (exclusion criteria).
If you are being considered for participation in a Research Study, you will be given an Information and Consent Form. You must carefully evaluate this consent form to see if this is something you really want to do, and are really committed to do.
If you meet all the above criteria, and sign the consent form, an extensive evaluation including laboratory and physical exam will follow. Afterwards, if you continue to qualify, you may proceed to he Study Drug Treatment Phase of the research study. Please remember, you cannot change any aspect of your medical care, nor can you undergo any study-related procedures, including blood testing, until you understand and sign the consent form.

For more information about the Current Research Studies being conducted at Gastroenterology Specialties, P.C., please contact the Research Department at 402-465-8888, extension 4600.