Frequently Asked Questions
Clinical research studies, also called clinical trials, look at an investigational medication to see if it is safe, how it works in the body, and if it works to treat a specific disease. Clinical research studies are conducted by study teams responsible for participants' study-related care. There are strict rules for clinical trials monitored and regulated by the U.S. Food and Drug Administration and other global regulatory agencies for trials outside the U.S.
The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals who take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations.
The ReNEW study is randomized and double-masked, meaning that some study participants will receive the investigational medicine, and others will receive a placebo. Two out of three participants will be assigned to receive the investigational medicine, while the other will receive the placebo. This process occurs at the randomization phase. Neither the study staff nor the study participant will know which study option (active drug or placebo) the participant is receiving. If you participate in the study, there is an open-label extension period at the end of the research study that you may be able to enroll in, in which the investigational medicine will be given to all participants.
Placebos are inactive substances made to look like the real medicine used in the clinical trial. Placebos allow the investigators to learn whether the medicine being given works better or no better than ordinary treatment. In order not to introduce bias, the patient and study staff will not know if the patient is being given the investigational medicine or a placebo.
Before you can participate in the ReNEW study, you will need to attend the screening visit(s) for initial tests and assessments as well as further assessments at Day 1 to see if you are eligible to participate. After all necessary tests and assessments have been completed, and if you are eligible to participate, you may enter the study and will be randomized to receive either the investigational medication or placebo. You will receive either the investigational medication or placebo for a total of 96 weeks (just under 2 full years).
Participation in any clinical research study is entirely voluntary, and participants may choose to withdraw from the study at any time for any reason. If you want to leave the study, you should discuss this with your study doctor who will provide additional information.