Biomarkers in clinical trials

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Hello members,

It is also observed that,

now Biomarkers are also used in the Proof of concept strategy

Biomarkers – Central

to PoC strategy [Choice of end-points]

A biomarker is a

characteristic that is objectively measured as an indicator of normal biological

processes, pathogenic processes, or a pharmacological response to a therapeutic

intervention that could serve as a

substitute for clinical outcome providing evidence to predict clinical benefit,

efficacy, and side effects

- biomarkers

that track the natural course of disease (type 0)

- biomarkers

that examine effects of intervention along with the known mechanism of action

of the drug without strict relationship to clinical outcome (type 1)

biomarkers considered the

ultimate ‘surrogate end points’ as in this type, ideally the change in the

biomarker is predictive of clinical outcome (type 2)

Choice of end-points for PoC

This depends on:

·

Whether the 'standard' endpoint is

simple/quick to measure

·

How variable the endpoint is

·

Whether it is an accepted/validated measure

of response to treatment

- In

asthma/COPD - FEV1

·

Whether a reliable biomarker exists

·

Modified end-points

- Is

there a way to increase sensitivity of the parameter (Dense Data measure)

- Is

an evoked response to the end-point possible

Composite outcome measure

RegardsDr Sanjay Yallappa ChoudhariJR2,Dept of PharmacologyGMC, Nagpur

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