Completed
This public workshop examined evidence generation for genomic diagnostic test development and explored the evidence needed to determine clinical utility, the study requirements that can help generate this evidence, and the necessary funding mechanisms to support this research to help advance discussions amongst policymakers and the broader public.
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Workshop
ยท2011
Ten years after the sequencing of the human genome, scientists have developed genetic tests that can predict a person's response to certain drugs, estimate the risk of developing Alzheimer's disease, and make other predictions based on known links between genes and diseases. However, genetic tests h...
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Description
An ad hoc committee will plan and conduct a public workshop that will examine evidence generation for genomic diagnostic test development. An array of stakeholder perspectives will be included in this activity; stakeholders may include payers, patient advocacy groups, policy makers, public health professionals, health care providers, laboratory test developers, and clinical investigators. The workshop will feature presentations and discussions to rigorously explore the strengths and limitations of the evidence that is being generated for clinical utility. The goal of the workshop will be to identify important issues surrounding genomic diagnostic test development, such as the evidence which is required from various stakeholders to determine clinical utility, the study requirements needed to generate this evidence, and the necessary funding mechanisms to support this research, to help advance discussions amongst policymakers and the broader public. An individually-authored summary of the workshop will be prepared by a designated rapporteur in accordance with institutional policy and procedures.
Collaborators
Sponsors
Department of Health and Human Services
Other, Federal
Private: For Profit
Private: Non Profit
Staff
Adam Berger
Lead
Major units and sub-units
Center for Health, People, and Places
Lead
Institute of Medicine
Lead
Board on Health Sciences Policy
Lead
Biomedical and Health Sciences Program Area
Lead