An investigational medication is a drug not yet approved for marketing by the U.S. Food and Drug Administration (FDA) or other global government offices. It is available only for use in clinical research studies to determine its safety and effectiveness in humans.
Learning all you can about clinical research studies can help you decide whether to take part in one. In order to gather information about the clinical research study you are considering, you should actively participate in the informed consent process, ask questions of the study doctor and other study staff members, and discuss the clinical research study with your regular doctor (if desired).
However, it is ultimately up to you to decide whether participation in the clinical research study is right for you.
The study staff will give you additional information about the investigational medication on the consent form. They will also explain potential side effects, risks, and benefits from participating in this study.
If you qualify for the RESOLVE-IT study, you will be required to take part in study visits over the course of 6 years. The study doctor and staff will be able to provide you with a schedule of appointments and procedures.
Genfit is the study sponsor. This means that Genfit is responsible for the overall study design and conduct. Genfit is a biopharmaceutical company that focuses on unmet patient needs in metabolic and inflammatory diseases, with a particular emphasis on the liver and gastroenterology.
Clinical research study protocols must be reviewed and approved by an Institutional Review Board (IRB) or Ethics Committee (EC). The IRB or EC is independent from the clinical study site. The sponsor also submitted the research study protocol to the U.S. Food and Drug Administration (FDA) for approval.
You can ask the study staff questions at any point before, during, and after the study. Before agreeing to participate, please make sure that you understand the responsibilities of study participants. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study staff at any time.
A placebo-controlled study means that one group of patients will receive the study investigational medication, while a second group will receive a placebo. A placebo looks just like the investigational medication but contains no active ingredients.
If a study is randomized, it means that study participants are assigned to a particular treatment group through a process called “randomization.” This process, which is similar to a coin toss, ensures that patients are randomly assigned to a study treatment group without any input from the study staff.
Study participation is completely voluntary, and you can end your participation at any time, for any reason. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you should leave the study early, the study doctor may ask that you return to the study site for a final visit, but there will be no negative impact on the care you receive.
Over the course of the study, you will continue to be treated by your regular doctor. This doctor will be in charge of providing all of your non-study-related care, including care for any existing or new medical problems. It is important that you discuss with the study staff any medical conditions you have, as well as any other medications or treatments that you may use, so that the study staff has a complete picture of your health before you start the study.
Yes. As part of the study, your local study doctor will review your symptom history, medications, and overall health to determine if you have NASH and to confirm if you are eligible to participate.