Our Clinical Research Coordinator, Mary Ellen McNeal, BSN, RN, manages the clinical studies here at GI For Kids. She works hand-in-hand with our physicians, nurses, and other medical staff to ensure that studies are conducted safely and according to the set protocols. She also communicates with regulatory bodies such as Institutional Review Boards (IRBs) and with each study’s sponsor. Mary Ellen works directly with patients and their parents to make sure everyone understands what they are being asked to do and that they know we are here to help every step of the way. If you would like to learn more about our research, please give Mary Ellen a call at (865) 546-3998.
Our Research Studies
Here at GI For Kids, we are actively involved in finding the best new therapies for pediatric patients with gastrointestinal disorders. We do this through participating in various clinical research studies. Depending on your child’s particular condition, he or she may be eligible to participate in one of our studies.
ELEVATE UC: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
Type of Study: Clinical Trial
Recruitment Status: Not yet enrolling at GI For Kids
DEVELOP: A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with Inflammatory Bowel Disease (IBD). Particular attention will be directed to recording safety outcomes reported in association with infliximab and other prescribed IBD therapies. In addition, information on disease status and quality of life will be collected.
Type of Study: Observational
Recruitment Status: No longer recruiting at GI For Kids
Clinical Research Overview
What is Medical Research?
Medical research, sometimes called biomedical or clinical research, is done in the hopes of advancing medical knowledge by studying patients with certain medical conditions. Some ways that these participants are typically studied are through questionnaires about how they are feeling, physical examinations by their provider, and/or through collection and analysis of tissues, blood, urine, or other samples from the study patient. One type of study that patients may participate in is called an observational study. In these studies, participants receive care for their conditions but are not assigned to specific interventions. Another type of study that patients may participate in is called a clinical trial. In a clinical trial, participants will be given special instructions/interventions (medical products like drugs, change of behavior, change of diet, etc.) by the study doctor. These studies are used to determine the safety and efficacy of the product or procedure that is being studied.
Why is Medical Research Done?
Medical research is done for the advancement of medical knowledge. When doctors learn more about diseases and conditions, they can more readily treat, diagnose, or prevent them.
Who conducts Medical Research?
A medical doctor, called a principal investigator, is the leader of the study at clinical sites. There will be a research team composed of other doctors, nurses, and other healthcare professionals trained to conduct research with human subjects. Research can be funded by academic medical centers, Federal agencies, voluntary groups, or pharmaceutical companies.