Applying Biomarker Information To Support Drug Discovery ... - IIR

Biomarker & Clinical Endpoint
Biomarker:
A characteristic that is objectively
measured & evaluated as an indicator of
normal biologic, pathologic processes,
or pharmacologic responses to a
therapeutic intervention (NIH workshop)
Values:
• understand of mechanism of action
• reduce the sample size and duration
• less variable & reproducible
• help trial design
Challenges:
Results may not be relevant or be able
to predict clinical outcomes
Clinical Endpoint:
A characteristic or variable that
reflects how a patient feels or
functions, or how long a patient
survives (NIH workshop)
Values:
• direct evidence to assess clinical
outcomes
Challenges:
• cost
• duration