Barriers to clinical adoption of next-generation sequencing: a policy Delphi panel's solutions.

PERSONALIZED MEDICINE(2017)

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摘要
Aim: Identify solutions to the most important policy barriers to the clinical adoption of next-generation sequencing. Materials & methods: Four-round modified policy Delphi with a multistakeholder panel of 48 experts. The panel deliberated policy solutions to (previously reported) challenges deemed most important to address. Results: The group advocated using consensus panels to promote consistency in payer policies and to standardize test reporting, and favored making genomic data-sharing a condition of regulatory clearance, certification, or accreditation processes. They were split on the role of US FDA. Conclusion: Panelists found common ground on solutions for health plan coverage policy consistency, data-sharing, and standardizing reporting, but were sharply divided on the role of the FDA in mitigating risks to patients.
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关键词
clinical data reporting,clinical genomics,coverage and reimbursement,intellectual property,next-generation sequencing,personalized medicine,policy,regulation
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