Accelerating the Development of Biomarkers for Drug Safety Workshop Summary (2009) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-5
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As biomedical science evolves and becomes increasingly computational and probabilistic, the tools for understanding the predictive value of biomarkers are changing, as are the criteria used 1A National Institutes of Health (NIH) working group has defined a biological marker or biomarker as "a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to therapeutic intervention" (Biomarkers Definitions Working Group, 2001)
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Yet the use of such combinations of biomarkers may introduce its own challenges, including technical issues of how to combine results, how to control quality, and how to interpret results in different clinical contexts. The improper use or interpretation of biomarkers can be detrimental in both clinical and research settings by misdirecting therapy or research activities.
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To compile a list of questions to address remaining obstacles to the development of biomarkers for drug safety 3. To discuss how to accelerate the development of biomarkers through public and private means The workshop benefited from three white papers on the state of biomarker development and use for the above three organ systems.
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In the past, these estimates of benefit/risk balance have come from projections from mechanistic reasoning, often without empirical data, or from average population outcomes from clinical trials. The identification of biomarkers that can distinguish patients particularly susceptible to risk or suggest an enhanced likelihood of benefit could make these calculations more accurate, and enable decisions to be tailored to the characteristics of individual patients.
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Chapter 6 summarizes future actions suggested by workshop participants to further the use of biomarkers in drug development. It should be noted that while the IOM Forum on Drug Discovery, Development, and Translation introduced the idea for this workshop, its planning was the responsibility of an independently appointed committee.
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