Clinical Trial Research
AG's History of Clinical Trial Research
In our service to the Central Texas area since 1980, Austin Gastro has contributed to major advances in the treatment of gastrointestinal diseases. In the last ten years we have participated in trials that helped to create the modern standard of care for hepatitis C, and have tested new treatments for Crohn's disease, ulcerative colitis, GERD, and irritable bowel syndrome. We've also participated in trials of popular drugs such as Humira®, Remicade®, Nexium®, and Cimzia®. All in all, our physicians have participated in over 70 clinical trials.
AG regularly conducts clinical trials of new and promising alternatives to standard gastrointestinal procedures for a wide variety of conditions. Trials give patients like you access to exclusive treatments and technologies while defraying the cost of standard treatments.
Join a Clinical Trial
Beginning in September 2017, Austin Gastroenterology and Pinnacle Research have partnered to conduct late phase clinical trials with a special focus on fatty liver disease. Through this partnership, we are able to offer clinical trials locally to patients in Austin for the first time. We provide research participants with trial-related procedures, office visits, and study medications at no cost. Qualified patients may receive some financial compensation for the time and travel associated with participation.
A clinical trial is a research study involving human volunteers and aimed at answering specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work and new ways to improve health.
Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, and includes details about schedules of tests and procedures, drugs and dosages, the length of the study, and the outcomes that will be measured. Each person participating in the study must agree to the rules set by the protocol.
Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the "standard treatments." Sometimes clinical trials study different ways to use the standard treatments so they will be more effective, easier to use and/or have fewer side effects. Sometimes studies are done to learn how to best use a treatment in a different population for whom the treatment was not previously tested.
Participants in clinical trials:
- Gain access to potential new treatments.
- Receive expert medical care for the condition being studied. Investigators are often specialists in the disease being studied.
- Help others by contributing to medical research and treatment advances.
- There may be unpleasant or serious side effects resulting from the treatment.
- The treatment may not be effective.
- Participation in the trial may be demanding and time consuming.
To protect the rights and welfare of clinical research participants, U.S. federal government agencies, including the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), oversee much of the clinical research done in this country.
In addition, there are committees known as Institutional Review Boards (IRBs) that oversee the centers where clinical research studies are conducted. IRBs review and approve study protocols to ensure that a clinical trial is ethical and that the volunteers' rights are protected. A participant in a clinical trial has access to the IRB that is overseeing the research and access to the physician and staff conducting the trial.
AG ensures patient confidentiality by meeting all federal guidelines for the Health Insurance Portability and Accountability Act (HIPAA).
For all clinical trial-related questions, please contact your Austin Gastro physician, or an Austin Gastro location near you.
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