A Network Model for Early Clinical Development
Benefits and Lessons Learned
Early clinical development (ECD) studies have become increasingly expensive in recent years. One approach to reducing timelines is the design and execution of hybrid clinical trial models in ECD studies, in which both healthy volunteers and patient populations participate. This approach, which is suitable for both small-molecule drugs and biologics (including biosimilars), allows sponsors to begin tracking the impact of their drug on the targeted population to more rapidly confirm early proof of concept. This white paper discusses lessons learned based on IQVIA’s experience with a vast number of ECD studies across the Asia-Pacific region, Europe, and the United States.