CAPROCK GASTRO RESEARCH
With a great desire to provide access to newly developed medications, Caprock Gastro Research was born. Patients with certain gastrointestinal disorders are able to explore and participate in a clinical drug trial. These trials are sponsored by the developing pharmaceutical company, following strict guidelines set forth by the Food and Drug Administration (FDA). Patients are under the direct supervision of our providers and are closely monitored under the protocol guidelines of the clinical trial. Caprock Gastro Research is currently involved in enrolling patients with Ulcerative Colitis or Crohn’s disease.
Inflammatory bowel disease (IBD) is a disease that represents a group of intestinal disorders that cause prolonged inflammation of the digestive tract. The digestive tract consists of the mouth, esophagus, stomach, small intestine and large intestine. Inflammation in the digestive tract can affect the breaking down of food, extracting nutrients and removing any unusable material and waste products. IBD can cause symptoms that can disrupt a person’s life and become life-threatening.
ULCERATIVE COLITIS (UC)
UC causes chronic inflammation of the large intestines, or the colon. The lining of the colon develops tiny open sores, or ulcers. Symptoms of UC are:
Crohn’s disease is chronic inflammation that can affect any part of the digestive tract from the mouth to the anus. It is commonly found at the end of the small intestine and the beginning of the large intestine (colon). Symptoms of Crohn’s disease are:
IMPORTANCE OF BEING TREATED
UC and Crohn’s disease not only significantly decrease a person’s quality of life but can also ultimately lead to death. If left untreated, they can also lead to:
There is no cure. Treatment of UC and Crohn’s disease is centered around the management of symptoms. Remission is the ultimate goal. There are 5 types of medications:
RESEARCH IN IBD
Scientists are currently exploring different options in treating and possibly finding a cure for Ulcerative Colitis and Crohn’s disease. There are many clinical research trials across the globe currently underway towards finding cures for these conditions. Caprock Gastro Research is proud to bring the latest treatment options to West Texas. If you have UC or Crohn’s disease and are interested in learning more about clinical research trials, please contact Caprock Gastro Research for a free consultation.
Frequently Asked Questions
Clinical research has inherent risks and potential benefits. By phase II, researchers may have some initial idea of what type of adverse events patients are seeing. The more patients that enroll in research studies, it gives researchers a better idea of potential adverse events that may occur with a particular medication. It is important to note that pharmaceutical companies are required to report all adverse and serious adverse events to the FDA, no matter how few patients actually had the event. Prior to participating in a clinical research study, your doctor will go over in detail the potential risks involved.
Many trials are placebo controlled meaning the drug is getting tested against a “sugar pill”. A patient in a placebo controlled trial certainly has a possibility of getting placebo but generally has more possibility of getting drug. Important to note that patients in clinical trials are followed more closely than regular patients. Patients that are not doing well in a trial on placebo will often be switched to the study medication.
Patients in clinical trials are followed more closely than regular patients. Those who are not doing well in a trial on placebo will often be switched to the study medication. Those who are not doing well on the study drug may be dose escalated or often discontinued from the clinical trial.
Only if your current doctor is an investigator on the study for which you are a candidate. Otherwise, your research team will be in close communication with your current doctor to aid in an easy transition once the study is complete.
Many clinical trials are funded by pharmaceutical companies. Though the pharmaceutical industry funds the studies, they are carried out by other groups to maintain fair balance. The US FDA oversees and regulates all studies involving human subjects.
While participating in a pharmaceutical sponsored clinical trial, all visits, study related procedures, and study related therapy are paid for by the pharmaceutical sponsor. A patient’s insurance should never be billed for study related visits. In the event a patient has a second diagnosis, which is not part of the study, the patient or their insurance will be responsible for those visits.
No, you will not be paid to participate, however you may be reimbursed for your time, travel etc.
This depends on the study. Some studies require a short visit every week while others require a longer visit every month. Study visits may last 15 minutes or as long as several hours in order to complete the required procedures set forth by the trial.