The intersection of advanced technologies and complex patient groups, along with the need to define clinical pharmacology using small sample sizes and short exposure periods, has shifted attention to endpoints that serve as intermediate or early indicators, rather than final outcomes. These endpoints, which signal the potential for lasting clinical benefit, have changed the structure, operations, analysis, and communication of proof-of-concept studies. While their form may vary across medical areas, these endpoints consistently aim to provide key insights into disease mechanisms and treatment promise as early as possible in clinical development.
Read our white paper on intermediate endpoints to learn more about their:
- Hierarchy and criteria for surrogacy
- Potential pros and cons for use
- Impact on trial operations
Authors:
Michael Murphy, MD, PhD
Chief Medical and Scientific Officer
