The Clinical Trials Division of Concorde Medical Group has extensive experience in successfully conducting a wide range of clinical research trials. We practice at our Kips Bay Office which is centrally located in mid-town Manhattan. The Clinical Trials Division operates within Concorde’s active multi-specialty practice, and provides our patients with early access to breakthroughs in medical technologies, treatments and pharmaceuticals. Clinical trials are performed to study how helpful and safe certain tests and treatments are. When most people hear the phrase clinical trial, they know it involves testing, but what does it actually mean?
What Is A Clinical Trial?
A clinical trial is a type of research that evaluates a treatment or test for its affects. These types of studies are carefully designed and reviewed to give the best form of treatment to the public. Meaning, having these types of trials is very important for all of our health care. When a clinical trial for a product or service is effective, you may very well use it in the future. Having this type of system in medicine prevents us from using a test or treatment that could cause immediate or long-term harm. A principal investigator leads the trial by designing it and choosing the research team. This is a carefully organized process with many rules and regulations that must be followed. Clinical trials are used for:
- New drugs not approved by U.S. FDA.
- New ways to give drugs.
- Drugs or procedures for symptom relief.
- Use of alternative medicines.
How Do Clinical Trials Happen?
Before a clinical trial can start, it must first be approved. With so many tests and treatments out there, certain ones take priority over others. Besides the competition, these types of trials need a lot of money for the multitude of testing. Clinical trials need sponsors which often are Government agencies, non-profit companies, and pharmaceutical (drug) companies. As protocol, the clinical trial sponsors are allowed the review the trial. Once the research plan has been approved, then the sponsor provides the money. Another obstacle for clinical trials to happen are approval by the Institutional Review Board (IRB). Each IRB has five individuals and involves at least one scientist, and a person who is not a scientist. After the clinical trial has commenced, the IRB reviews the progress of the trial every year.
We are currently enrolling for the following clinical trials:
- Ulcerative Colitis – A chronic inflammatory bowel disease that leads to inflammation in the digestive tract.
- Crohn’s Disease – A chronic inflammatory bowel disease that affects the lining in the digestive tract.
- Clostridium Difficle – Inflammation of the colon which is caused by the bacteria called Clostridium difficile.
- Non-Alcoholic Steato Hepatitis (NASH/Fatty Liver Disease) – The buildup of liver fat in people who drink little to no alcohol.
- Celiac Disease – An immune reaction to eating gluten.
- Primary Biliary Cholangitis – An autoimmune disease that leads to progressive destruction of bile ducts.
- SIBO-NASH – The small intestinal bacterial overgrowth in nonalcoholic steatohepatitis.
Registry studies for:
- Calprotectin – A protein release by a type of white blood cell known as neutrophil.
- Fatty Liver Disease – The increased built-up of fat in a persons liver.
- HUMIRA – Ulcerative Colitis Patients ONLY – A prescription to help moderate severe ulcerative colitis.
- Short Bowel Syndrome – A malabsorption disorder which is caused by the lack of a functional small intestine.