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Article History

Received: 4 June 2019

Accepted: 4 September 2019

First Online: 21 October 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, JPAI received research support through the METRICS from the Laura and John Arnold Foundations and through an unrestricted gift from Sue and Bob O’Donnell. 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, from the Agency for Healthcare Research and Quality (R01HS022882), and from the Laura and John Arnold Foundation. SSD received support as a Scholar in the Yale University/Mayo Clinic FDA CERSI. VV received support through the National Institutes of Health. JDW received research support through the Meta Research Innovation Center at Stanford (METRICS) and Collaboration for Research Integrity and Transparency from the Laura and John Arnold Foundation. The other authors declare that they have no competing interests.