Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments Proceedings of a Workshop (2020) / Chapter Skim
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2 Understanding Biomarker Use and Its Potential for Determining Health and Function
2 Understanding Biomarker Use and Its Potential for Determining Health and Function
Pages 5-16
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From page 5... ...
. • Using the World Health Organization International Clas sification of Functioning, Disability and Health framework in biomarker usage can improve the precision of care as the framework incorporates personal and environmental factors that can moderate function, and ultimately, quality of life (Wagner)
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From page 6... ...
FNIH efforts, he said, have created and led cross-sector efforts that validate and qualify biomarkers and other drug development tools to accelerate decision making for the development of new therapeutics and health technologies. So far, the Biomarkers Consortium has contributed to the advancement of 14 therapeutics and generated tools being used in drug development (FNIH, 2020; Menetski et al., 2019)
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From page 7... ...
. BOX 2-1 Definitions of Key Terms in Biomarker Research Select terms and definitions provided by the Social Security Administration for verification include: • Biomarker: A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, the presence of disease, or pharmacologic responses to a therapeutic intervention.
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From page 8... ...
Evidentiary Criteria Framework Building on the examples, Menetski described the evidentiary criteria framework, which is used to determine biomarker qualification (if enough data are present to use a biomarker) and provide a consistent set of characteristics to describe and define the biomarker program with a regulatory
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From page 9... ...
. The goal of the framework is to enhance submission quality and predictability of the qualification process, and clarify the type and amount of evidentiary criteria needed.
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From page 10... ...
, beginning with the absence of disease, which she stated "is most relevant to the medical model and is based on the state of science, signs, and symptoms." She acknowledged that this is likely the most widely accepted definition of health in the health care field. The second definition describes health as "a state that allows individuals to adequately cope with all demands of life." She added, "This definition is important because it begins to make assumptions about health that are based on level of function." The third definition of health is "a state of balance or equilibrium between individuals and their social and physical environments." She emphasized the importance of this third definition because "here, health reflects an internal equilibrium to get the most from life despite disease, and inherent to this definition then is the incorporation of values that individuals have about their cultures and communities." Based on these definitions, Wagner concluded that health and function are interrelated, and multiple elements should be considered in terms of functioning.
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Wagner pointed out that these impairments can "lead to symptoms such as cognitive dysfunction, balance deficits, paralysis, and changes in mood that can be related to common diseases associated with disability assessments, such as dementia, posttraumatic stress disorder, stroke, schizophrenia, spinal cord injury, traumatic brain injury, and degenerative joint disease." From this first element of the WHO ICF, Wagner said, we can "link symptoms to disease." The second element of the WHO ICF is characterized by activities, which are "things individuals do to be independent members of the community," she said. She said that activities are focused on execution of a daily task or action and are things we need to do to care for ourselves and carry out our goals in life.
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From page 12... ...
She acknowledged the immense progress needed to reach this goal, but she also highlighted existing resources that will help bridge the gap, such as the Precision Medicine Initiative, All of Us Research Program, and the Million Veteran Program (MVP)
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Workshop participants and planning committee members posed questions related to progress in biomarkers research and discussed various factors that should be considered when implementing biomarkers in practice. Challenges in Development and Advancement of Biomarkers Rosenbaum asked the panelists about the timeline of implementing biomarker research into standard practice.
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From page 14... ...
He explained that biomarkers can require varying levels of precision and that accuracy also factors into each scenario, as explained in the evidentiary criteria framework. Using cholesterol as an example, he explained that a biomarker could have long-term effects and require less precision in measuring versus oxygen levels that could have more immediate effects.
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From page 15... ...
Wagner said, "There are some biological differences that come in part as a result of our personal biology that we inherit over the generations, and race and ethnic background can factor into that." Other factors, such as access to health care and health care maintenance and prevention, also play a role in understanding and applying biomarkers, said Wagner. Together, these all create a complex environment that we will need to navigate when using these biomarkers to try and understand disease and function more clearly, she added.
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