To provide the very latest in medical care to our patients, Gastroenterology Associates of Tidewater work with major medical centers and pharmaceutical companies in developing new drugs and techniques in the care of gastrointestinal disease.
The following are Frequently Asked Questions regarding participating in a clinical research trial.
By participating in a clinical research trial, participants have access to the newest, most cutting-edge medication before they are in the local pharmacies.
Some clinical studies offer compensation for participants. The amount depends upon each study.
Gastroenterology Associates of Tidewater has been participating in clinical trials since 1995. Our research studies have included Hepatitis C, irritable bowel syndrome, Gastroesophageal Reflux Disease (GERD) and bowel preparation for colonoscopy and many others. All of the drugs and treatments we have tested have received FDA approval for use to date.
In addition to our well-trained physicians and nursing staff, GATGI employs a clinical research coordinator to assist in the management of our research studies and patients.
Your safety is the main priority during a clinical trial. It is important to take all our medications as assigned, keep all your scheduled visits and let the research coordinator or physician know how you feel and if you have developed any side effects.
When participating in a research study, it is possible participants will be assigned a placebo drug rather than the active drug being tested.
A placebo is an inactive or “dummy” pill randomly assigned to some of the volunteers to compare the results of the drug under study. The physician, research coordinator and volunteer do not know who is receiving the placebo. In some studies all subjects receive the active drug, but different drugs or different dosages. The chances of receiving a placebo or various drug treatments are disclosed to participants in the consent form.
If there are medical problems during the study, investigators may call the director of the study to find out if the participant is taking an active drug or placebo tablet.
The assignment of drug or treatment, as well as placebo in some studies, is assigned by random chance. We cannot influence to which group participants are assigned.
Participants may choose to discontinue their participation in a study at anytime. It may become necessary for your doctor to remove you from the study for reasons such as the participant’s safety, not following the participation requirements of the study, or the study is complete and the drug has been released. All study medications must be returned if a participant is withdrawn from a study.
A participant’s privacy and medical records are protected and confidential. The information provided to the medical centers, pharmaceutical companies and FDA will not include a participant’s identity.