Clinical Feasibility Studies

What is a clinical feasibility trial?
Also known as first-in-human studies, or early clinical experience trials, clinical feasibility trials are a step in the development of a new medical device or therapy or in testing an existing product for a new indication. A clinical feasibility trial is a research study in which the product is used in a small number of human patients who are carefully monitored. It is typically conducted after bench testing and/or pre-clinical animal testing have demonstrated expected safety of the investigational product. The feasibility trial is meant to provide enough information to determine whether the product is safe enough to proceed with larger studies of more patients and whether the product seems to function as intended. Importantly, it is meant to show if a device or therapy does not function as intended so that improvements can be made to its design prior to investing in large pivotal clinical trials or regulatory marketing applications.