15/10/2026
๐ ๐ฌ๐ฎ๐ซ๐ซ๐จ๐ ๐๐ญ๐ ๐๐ง๐๐ฉ๐จ๐ข๐ง๐ญ ๐๐๐ง ๐๐๐๐๐ฅ๐๐ซ๐๐ญ๐ ๐ฒ๐จ๐ฎ๐ซ ๐๐ฅ๐ข๐ง๐ข๐๐๐ฅ ๐ฌ๐ญ๐ซ๐๐ญ๐๐ ๐ฒ. ๐๐ฎ๐ญ ๐ก๐จ๐ฐ?
In , surrogates have been used to expedite approvals by replacing overall survival, thereby shortening the development program by 1 to 2 years. This is best done when a surrogate can be properly validated at both the patient and trial level.
More recently, a new avenue has been opened by the regulatory acceptance of partially validated surrogates when patient benefit is expected from a treatment that impacts a patient-level surrogate, such as minimal residual disease and circulating tumor DNA, increasing the chance of accelerated approval based on these novel endpoints.
For decades, 's experts have helped shape the science of surrogate endpoints validation, playing a pivotal role in establishing the meta-analytical framework that has informed approaches used by regulatory and health technology assessment bodies, including the FDA and Germany's IQWiG.
With nearly 100 peer-reviewed publications and pioneering methodological expertise, our strategic consulting team helps sponsors navigate complex endpoint strategies, from clinical study design through regulatory submission and interactions with health authorities.
Discover IDDI's Strategic Consulting expertise: https://iddi.com/services/strategic-consulting/