Phase I hybrid studies as described here are clinical trials that incorporate healthy volunteers as well as patients from the target indication in a single protocol. The insights gained from such hybrid studies can be extremely valuable, potentially delivering a deeper understanding of the safety, tolerability, and pharmacokinetics of a product, as well as a greater insight into the product’s pharmacodynamic effects and therapeutic potential — all at a very early stage of clinical development. Read our white paper to learn about the opportunities and limitations of hybrid studies in Phase I.
Authors:
Michael Murphy, MD, PhD
Chief Medical and Scientific Officer
Sherilyn Adcock, RPh, PhD
Chief Scientific Officer, Early Phase Development
