Abstract
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.
Original language | English (US) |
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Pages (from-to) | 339-354 |
Number of pages | 16 |
Journal | Personalized Medicine |
Volume | 14 |
Issue number | 4 |
DOIs | |
State | Published - Jul 2017 |
Keywords
- Clinical data reporting
- Clinical genomics
- Coverage and reimbursement
- Intellectual property
- Next-generation sequencing
- Personalized medicine
- Policy
- Regulation
ASJC Scopus subject areas
- Molecular Medicine
- Pharmacology