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Article History

Received: 18 October 2018

Accepted: 8 May 2019

First Online: 17 June 2019

Ethics approval and consent to participate

: This study used publicly available information and did not require ethics approval from the Yale University School of Medicine Human Research Protection Program.

: Not applicable

: In the past 36 months, JDW received research support through the Meta Research Innovation Center at Stanford (METRICS) from the Laura and John Arnold Foundation. JSR received research support through Yale from Johnson and Johnson to develop methods of clinical trial data sharing, from Medtronic, Inc. and the Food and Drug Administration (FDA) to develop methods for postmarket surveillance of medical devices (U01FD004585), from the Centers of Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting, from the FDA to establish a Center for Excellence in Regulatory Science and Innovation (CERSI) at Yale University and the Mayo Clinic (U01FD005938), from the Blue Cross Blue Shield Association to better understand medical technology evaluation, and from the Agency for Healthcare Research and Quality (R01HS022882). SSD receives support as a Scholar in the Yale University/Mayo Clinic FDA CERSI. JEM and JSR receive funding from the Laura and John Arnold Foundation in connection with the Good Pharma Scorecard.

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