Photograph by Darlyne A. Murawski, National Geographic. The peanut worm has a proboscis that resembles an elephantâs trunk, as well as a mouth that boasts an impressive array of tentacles. This bottom burrower feeds on organic materials found in mud and sand, and when done feasting it can turn the proboscis inside out to retract it inside its body.
Early clinical development is primarily composed of human proof of principle/pilot clinical studies â to confirm feasibility in human, explore patient populations and performance claims. Concomitantly, subsequent clinical trials are outlined and prepared for.
A clinical trial is a carefully designed study which tests the benefits and risks of a specific medical treatment or intervention, such as a new drug or a behavior change (e.g., diet).Once researchers have completed a rigorous screening and preclinical testing process, the company files an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).