Foundational analysis
Why better tools did not automatically mean better R&D
Scannell and colleagues described a historical decline in new drug approvals per inflation-adjusted R&D dollar, despite improvements in many discovery tools.
Regulatory explainer
A promising signal is not the same as a proven benefit
US Food and Drug Administration · Dec 21, 2017
What the source reports
FDA explains why surrogate endpoints require careful evaluation: a biomarker may not capture a treatment’s full benefits and risks.
Why it belongs here
Keep patient-relevant outcomes in view when an early laboratory signal looks encouraging.
WHAT THIS DOES NOT ESTABLISH
Do not describe an exploratory aging clock or assay as a validated surrogate for healthy lifespan without appropriate evidence.
Before you use it
Read the original source, check its population or model and intended use, and review uncertainty, disclosures and any subsequent updates. This note is a guide to reading, not a substitute for the paper or guidance.
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Human observational study
What a proteomic aging clock can tell us
A 204-protein clock, developed using 45,441 UK Biobank participants, was associated with future disease and mortality risk and evaluated in Chinese and Finnish cohorts.
Final guidance
How model-informed evidence should support a decision
ICH M15 addresses planning, evaluation and documentation of model-informed drug-development evidence. FDA’s final guidance is dated June 2026.