for advocates: Perspectives on Biomarker and Surrogate Endpoint Evaluation

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Copying from text:

" Biomarkers are characteristics that are objectively measured and evaluated

as indicators of normal biological processes, pathogenic processes, or

pharmacological responses to an intervention. "

... Page 2: IOM provides here advice " on the topic of biomarker and surrogate

endpoint evaluations in chronic disease.

..These FDA centers expressed concerns regarding the limited number of

surrogate endpoints*, and the absence of an agreed-upon, systematic, and

transparent process for biomarker assessment. "

.. Surrogate endpoint: " In clinical trials

<http://en.wikipedia.org/wiki/Clinical_trial> , a surrogate endpoint (or

marker) is a measure of effect of a certain treatment that may correlate

with a real clinical endpoint

<http://en.wikipedia.org/wiki/Clinical_endpoint> but doesn't necessarily

have a guaranteed relationship. [For example, a tumor response, might or

might not predict a longer and better life from the drug that caused it. ]

http://en.wikipedia.org/wiki/Surrogate_endpoint

<http://www.nap.edu/catalog.php?record_id=13038> Perspectives on Biomarker

and Surrogate Endpoint Evaluation: Discussion Forum Summary (2011)

http://books.nap.edu/openbook.php?record_id=13038

<http://books.nap.edu/openbook.php?record_id=13038 & page=1> & page=1

All the best,

~ Karl

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