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[Appendix B] 1 Introduction
Pages 259-274

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From page 259...
... In order for consumers, physicians, drug developers, and policy makers to make informed decisions based on biomarkers, it is important to understand the amount, strength, and quality of data sup porting the use of any specific biomarker to direct decisions in clinical care, drug development, public health, and health policy decisions. Every time a parent takes a child's temperature looking for a fever, they are using a biomarker to assess for illness.
From page 260...
... Biomarker evaluation is often thought of as two unlinked steps: analytical validation of biomarker tests and biomarker qualification. Biomarker qualification is the evidencebased process of linking a biomarker with one or more clinical endpoints.
From page 261...
... Center for Food Safety and Applied Nutrition (CFSAN) , in conjunction with the FDA's Center for Drug Evaluation and Research, approached the IOM for advice on the topic of biomarker and surrogate endpoint evaluation, noting the limited number of surrogate endpoints available, the high cost of evaluating possible surrogate endpoints biomarkers, and the absence of an agreed-upon, systematic, transparent process for biomarker evaluation.
From page 262...
... Little consistent, reliable information is currently available regarding how consumers can know which foods might have health benefits beyond basic nutrition. Recently questions have arisen related to use of biomarkers in substantiating health claims about foods, namely whether the use of biomarkers to draw conclusions about the health benefits of nutrients, foods, and supplements should be encouraged, and how information about the uncertainty associated with using biomarkers in this way can be communicated to consumers.
From page 263...
... Authorized and qualified health claims, which describe links between a food substance and a reduction in risk for a disease, may include data based on the measurement of surrogate endpoints or risk biomarkers as justification for the claims. It is uncommon for produc 3 See http://www.biomarkersconsortium.org.
From page 264...
... Claims must be evaluated and authorized by the FDA in most cases. In some cases, health claims can be authorized based on a statement from an authoritative body, such as the NIH or the National Academy of Sciences.4 The lack of an agreed-upon, transparent process for biomarker evaluation has been seen as one of the roadblocks to a broader selection of surrogate endpoints on which claims could be based.
From page 265...
... . In its Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims, CFSAN defined risk biomarkers as "biological indicators
From page 266...
... . TABLE 1-2 Use of Biomarkers in Drug Development Biomarker Use Drug Development Objective Target validation Demonstrate that a potential drug target plays a key role in the disease process Early compound screening Identify compounds with the most promise for efficacy and safety Pharmacodynamic assays Determine drug activity; select dose and schedule Patient selection In clinical trials, patient selection (inclusion/exclusion)
From page 267...
... …a surrogate endpoint that is reasonably 314 Section 314.510b likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit. Guidance for Industry: Evidence- Surrogate endpoints are risk biomarkers that based review system for the have been shown to be valid predictors scientific evaluation of health of disease risk and therefore may be used claimsc in place of clinical measurements of the onset of the disease in a clinical trial.
From page 268...
... The ideal surrogate endpoint is a disease marker that Guide to Clinical Trials (Spilker, 1991) reflects what is happening with the underlying disease.
From page 269...
... , the Biomarkers Definitions Working Group definition is used. The CFSAN definition does not include a critical com ponent of the definition of surrogate endpoints: the ability to predict clinical benefit or harm of an intervention based on a change in the surrogate endpoint.
From page 270...
... is an example. Because an MI in a person outside the hospital is detected from symptoms, it is a plausible clinical endpoint.
From page 271...
... Chapter 2 reviews previous biomarker and surrogate endpoint evaluation processes. Chapter 3 presents the committee's recommended biomarker evaluation framework.
From page 272...
... 2007. Information-theory based surrogate marker evaluation from several randomized clinical trials with continuous true and binary surrogate endpoints.
From page 273...
... 2009. Meta-analysis for the evaluation of surrogate endpoints in cancer clinical trials.


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