Including Patients And Healthy Volunteers In First-In-Human Clinical Trials
The opportunities and limitations of “hybrid” clinical studies
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.