Messner Donna A, Koay Pei, Al Naber Jennifer, Cook-Deegan Robert, Majumder Mary, Javitt Gail, Dvoskin Rachel, Bollinger Juli, Curnutte Margaret, McGuire Amy L
Center for Medical Technology Policy, Baltimore, MD 21202, USA.
School for the Future of Innovation in Society, and Consortium for Science, Policy & Outcomes, Arizona State University, Tempe, AZ 85281, USA.
Per Med. 2017;14(4):339-354. doi: 10.2217/pme-2016-0104. Epub 2017 Jun 23.
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.
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.
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.
确定解决阻碍下一代测序临床应用的最重要政策障碍的方案。
对由48名专家组成的多利益相关方小组进行四轮改良政策德尔菲法。该小组审议了针对（先前报告的）被认为最需解决的挑战的政策解决方案。
该小组主张利用共识小组来促进支付方政策的一致性并使检测报告标准化，且倾向于将基因组数据共享作为监管批准、认证或认可程序的一个条件。他们在美国食品药品监督管理局（FDA）的作用问题上存在分歧。
小组成员在健康计划覆盖政策一致性、数据共享和报告标准化的解决方案上找到了共同点，但在FDA在降低患者风险方面的作用问题上存在严重分歧。
