Perspectives on Biomarker and Surrogate Endpoint Evaluation Discussion Forum Summary (2011) / Chapter Skim
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4 National Institutes of Health Perspectives
4 National Institutes of Health Perspectives
Pages 43-50
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From page 43... ...
has played an instrumental role in advancing biomarker discovery, development, and qualification. The agency has initiated a range of efforts, including workshops and consortia, aimed at improving stakeholder col laboration and expanding public access to information on promising biomarkers.
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From page 44... ...
However, the results clearly associated treatment to suppress ventricular premature beats with increased death rates. Decades later, the NHLBI funded another trial examining the potential of an implantable defibrillator to reduce sudden cardiac death rates,
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For a genetic biomarker example, Dr. Lauer described a recent genomewide association study of Alzheimer's disease involving over 35,000 subjects, of whom 8,371 developed Alzheimer's disease (Seshadri et al., 2010)
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From page 46... ...
Within a year of this trial, the American College of Cardiology and American Heart Association changed their practice guidelines to indicate that PCI of a totally occluded artery after a com pleted infarct in an otherwise stable patient is not recommended (Antman et al., 2008)
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From page 47... ...
trial,4 which is a randomized clinical trial assessing the value of using genetic markers as a biomarker for patient response to anticoagulant therapy warfarin. Patients in the trial are being randomized to have their warfarin dosage determined by a standard clinical strategy versus a strategy informed by genomics; the primary outcome will be correct anticoagulation within a relatively short period of time, said Dr.
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From page 48... ...
"Over the years, the very best data have been developed against those endpoints in those two rather specific populations," he observed, and the possibility that vitamin D status affects other chronic conditions is "part of a very active, ongoing collaborative set of studies that are funded by the NIH, with lots of input from others." The ODS works with the Centers for Disease Control and Prevention (CDC) to enhance availability of data on vitamin D status in a nationally representative sample of the United States through the National Health and Nutrition Examination Survey (NHANES)
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From page 49... ...
Whether vitamin D status indicates anything except level of risk for rick ets in children and for falls and fractures in the elderly remains unknown. "Given that," he said, "there are important reasons for people to want to consider taking vitamin D: the notion that their risk for type 2 diabetes, type 1 diabetes, cardiovascular disease, cancer, and a great many other chronic disease endpoints may go down," so it is important that studies address the link between vitamin D and a variety of chronic diseases.
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