TY - JOUR
T1 - Barriers to clinical adoption of nextgeneration sequencing
T2 - A policy Delphi panel's solutions
AU - Messner, Donna A.
AU - Koay, Pei
AU - Al Naber, Jennifer
AU - Cook-Deegan, Robert
AU - Majumder, Mary
AU - Javitt, Gail
AU - Dvoskin, Rachel
AU - Bollinger, Juli
AU - Curnutte, Margaret
AU - McGuire, Amy L.
PY - 2017/7
Y1 - 2017/7
N2 - 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.
AB - 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.
KW - Clinical data reporting
KW - Clinical genomics
KW - Coverage and reimbursement
KW - Intellectual property
KW - Next-generation sequencing
KW - Personalized medicine
KW - Policy
KW - Regulation
UR - http://www.scopus.com/inward/record.url?scp=85022185605&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85022185605&partnerID=8YFLogxK
U2 - 10.2217/pme-2016-0104
DO - 10.2217/pme-2016-0104
M3 - Article
C2 - 29230253
AN - SCOPUS:85022185605
VL - 14
SP - 339
EP - 354
JO - Personalized Medicine
JF - Personalized Medicine
SN - 1741-0541
IS - 4
ER -