Clinical trials evaluate the safety and effectiveness of a new medical treatment or device in people with specific medical conditions. It is one of the most critical stages of drug development and is carefully regulated by the FDA (Food and Drug Administration) and an IRB (Institutional Review Board). The FDA reviews the pharmaceutical company, research site and conduct of the clinical trial. It is the IRB’s role to review and evaluate clinical research from the patient’s point of view to ensure that the risks of involvement in the study are reasonable and that you are provided with enough information to make an informed decision as to whether to participate.
Participation in a clinical trial is a partnership and a commitment between the research team and volunteer patients. It is the final test in a series of many carefully controlled scientific studies that are done to improve the quality of life of people with medical conditions such as yours.
Our research study staff will contact when we have a study that you may qualify for, research is voluntary, and you do not need to participate if you do not want to.
You will be given the Informed Consent to review to help you decide if you want to join the study. The informed consent document provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual’s rights as a subject. The Informed Consent document must be signed before any study procedures begin. This will be done at our research site.
You will have a screening visit(s) where you will have procedures performed to see if you qualify for the study. Every study is different, and the Informed Consent document will describe the required screening procedures. Common screening procedures include a physical exam, vital signs, an EKG, pulmonary function tests for asthma studies, laboratory (blood) testing, medical history, and medication history collection.
Your screening procedures will be evaluated, and you will be notified if you continue to qualify for the study. There is a possibility you may not qualify to continue, and this is not your fault.
If you qualify to continue, you will be asked to come in for the scheduled visits and perform the listed procedures in the Informed Consent document until your study participation is complete.
You can contact your study coordinator any time you have a question about the study. Our research department has a physician or nurse practitioner available if you have a medical problem while you are on the study.
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.” – Good Clinical Practice