Question: Am I safe or am I just a “guinea pig”?
Answer:The protection of your safety and rights are essential to conducting a clinical trial. The Institutional Review Board, (IRB) must grant approval to any doctor conducting a clinical trial. They also examine all study protocols to ensure patients’ rights are protected and that the research study in no way presents an undue risk. All clinical trial patients in the United States are required to sign an “informed consent form.” This form details the nature of the study, the investigational medicine; and any risks involved.
Answer:Yes. All members of our research staff have advanced training and experience in the field of clinical research. All of our physicians are board certified in their respective fields.
Answer:Yes. During the study you will be informed of any medications you may be taking as well as any information pertaining to the medicine being investigated in the research study.
Answer:Yes. Financial compensation for your time and travel is provided for in most clinical studies.
Answer:No. Each clinical study is handled individually. Most do involve an initial exam and a few brief follow-up office visits.
Answer: No. You will receive all of your study-related medical care and diagnostic testing at no cost. Many studies include expensive tests such as an endoscopy, EKG, X-rays and complete blood work.
Answer: Study testing is done mainly in our office. There are occasions when our associated physicians will use their private practice office for special tests.
Answer: As part of the clinical trial, research volunteers are given medical evaluations such as physical exams, monitored symptom reporting, progress evaluations, and diagnostic tests all at no cost.
Answer: Yes, with regular follow-up visits and evaluations.