Gastro Health offers an opportunity to participate in clinical trials for
new medications. By volunteering to participate, our patients can help others by contributing to medical research.
Our physicians have participated in the development of many important products for the treatment of gastrointestinal conditions. For example, our team has been involved in the clinical trials for Remicade, Humira, Amitizia, Lialda, Asacol, Osmoprep, Harvoni and Sovaldi.
Today, all new drugs or medical devices need to go through extensive testing prior to being approved for use by patients. In order to come to the market a medication or device needs to go through preclinical trials, which are used to evaluate the safety and potential effectiveness in experimental models. If the drug or device seems promising, it then goes into clinical testing, which consists of the following four phases.
PHASE 1These studies determine the safety and dosing schedule in healthy volunteers who generally have no medical issues and are paid to take the drug in order to evaluate its safety.
PHASE 2 These studies involve between 150 – 400 subjects to determine if a drug works for a specific condition and to gather additional safety data.
PHASE 3 These studies are considered pivotal in the approval process. They involve from 500-3000 subjects and are what is generally used by the FDA and other government agencies to see if a drug works for a specific disease and if it is safe to use.
PHASE 4 These studies generally are used to evaluate the safety of a medication after it has been approved to go on the market.
- Before participating in a clinical trial you will be asked to sign an informed consent approved by an Independent Review Board (IRB) that approves the conduct of the study and make sure it conforms to the principles of the Declaration of Helsinki and FDA guidelines. For further details you can visit www.fda.gov.An informed consent is required to provide you with the following information:The purpose of the study.
- How long the study will last and the number and frequency of visits required.
- Procedures and tests that may be required by participating in the study.
The potential risks and benefits of study medication.
- Other treatment options that may be available.
- If there is a chance that subjects participating in a study receive a placebo.
- Who will have access to your medical records.
- Who will pay for medical care if you are injured in the study.
- Awareness that as a research volunteer you can stop your participation at any time without bias.We are currently conducting a clinical trial comparing Humira to Entyvio in patients with ulcerative colitis. If you would like further information please contact Dr. Howard Schwartz or Karla A. Gonzalez, MA, CCRC at 305-913-0666 ext 1360.