You will continue to be under the care of your doctor while participating in the NET-PD study. You will, however, be asked to follow the directions of the study doctor during the course of the study. The study doctor and your doctor may need to discuss your health care while you participate in the study.
The Phase III Creatine study will last for a minimum of 5 years; for some participants it may last as long as 7 years. During the first year of the study you will be seen a minimum of four times. During the second year you will be seen at least two times. Thereafter, you will be seen every year for an in-person visit and have a telephone consultation between visits. It may be necessary for you to have an extra visit if you are having concerns about your PD or if your laboratory tests need to be repeated.
All clinical trials have federally regulated safeguards to protect participants. These include an Institutional Review Board and a committee of clinical research experts called a Data Safety and Monitoring Board. Also, throughout the years it takes to develop and test new drugs, the U.S. Food and Drug Administration carefully oversees the research process to protect patients from unreasonable risks.