Clinical trials are research studies involving human volunteers to see how safe and effective a potential medication is in preventing, treating, or curing a particular disease or condition. Such trials are essential research tools for advancing medical knowledge and patient care.
Just about every medication, medical device, or surgical procedure has undergone rigorous clinical studies before being approved for use.
There are substantial benefits to volunteering to be in a clinical trial.
You have a two out of three chance of receiving the drug. Even if you receive the placebo, you may still benefit from the other medical care you receive while a participant in the trial.
You should speak to your doctor to learn about the risks and benefits of any clinical trial before making the decision to participate.
Clinical trials are characterized by Phases, with each phase dictating the goals of the study and the type of subjects or patients that will participate.
Drug discovery and testing, in animals and test tubes
Safety evaluation in healthy subjects
Safety and efficacy in NASH cirrhosis patients
Confirmation of safety and efficacy in a larger group of NASH cirrhosis patients
Medication approved; research continues
The NAVIGATE Study is a seamless Phase 2b/3 trial, meaning that it will begin by supporting the potential benefits of the drug and the optimal dosage, then it will add additional participants and move into a larger trial to confirm safety and efficacy.
Every clinical trial has a clear goal, a well-defined protocol, and guidelines on who is eligible to participate. Investigational medications like belapectin are evaluated for safety and efficacy, generally in comparison with a placebo (a substance that has no medical effect).
Patients are randomly assigned to receive either the drug or the placebo. In a double blind trial such as the NAVIGATE Study, neither the patient nor the medical staff know which of the two the patient is receiving.
Participating in a clinical trial can provide early access to potential new treatments, but trials are not without their risks. Talk to your doctor about whether participating in the NAVIGATE Study is right for you.