About Clinical Trials
Clinical trials are the backbone of modern medicine. Before a new therapeutic can be made available to the general public, rigorous tests involving multiple studies on human volunteers are required. These studies are referred to as clinical trials and are regulated by the Food and Drug Administration (FDA) in the United States, as well as similar regulatory agencies worldwide. Clinical Trials evaluate the efficacy, safety, and/or tolerability of drugs, devices, and other kinds of medical treatments. Each clinical trial is designed to answer specific questions about the treatment at the center of the study.
There are a few different types of clinical trials. They are usually divided into four categories or phases. The National Institutes of Health (NIH) define clinical trial phases in the following way:
- Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Delcath completed Phase 1 trial.
- Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Delcath completed multi-arm phase 2, NET results presented at ESMO 2011.
- Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Delcath completed randomized phase 3, preliminary results were presented at ASCO and updated at ESMO 2011.
- Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
- Expanded Access Program: For patients who cannot participate in a clinical trial of an investigational drug, but have a serious disease or condition that may benefit from treatment with the drug, FDA regulations enable manufacturers of such drugs to provide those patients access to the drug under certain situations, known as “expanded access.” The intent of expanded access is to provide treatment for a patient’s disease or condition, rather than to collect data about the study drug.
Trial Enrollment Information
Expanded Access Study of Melphalan CS-PHP with Delcath System in Patients With Ocular/Cutaneous Melanoma Mets to Liver
Our Expanded Access Program (EAP) in the United States is now open for enrollment"
Delcath does not make any claim whatsoever, real or implied, about the efficacy or safety of any therapy, drug, system, or technique under active research.