Wilcox, Marsha A.
Savitz, Adam J.
Addington, Anjené M. http://orcid.org/0000-0001-7770-299X
Gray, Gary S.
Guinan, Eva C.
Jackson, John W.
Lehner, Thomas
Normand, Sharon-Lise
Ranu, Hardeep
Senthil, Geetha
Spertus, Jake
Valeri, Linda
Ross, Joseph S.
Article History
Received: 5 October 2017
Revised: 3 May 2018
Accepted: 15 May 2018
First Online: 27 June 2018
Competing interests
: M.A.W. and A.J.S. are employed by Janssen Research & Development, LLC. In the past 36 months, J.S.R. received research support through Yale University from Johnson & Johnson to develop methods for clinical trial data sharing, from Medtronic, Inc. and the Food and Drug Administration (FDA) to study issues in post-market medical device surveillance, from the Food and Drug Administration (FDA) to establish the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI), from the Centers of Medicare and Medicaid Services (CMS) to develop measures for public reporting of hospital and physician quality, from the Blue Cross-Blue Shield Association (BCBSA) to advance pre-market evidence generation for medical products, from the Agency for Healthcare Research and Quality, and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency (CRIT) at Yale. E.C.G. and G.S.G., and H.R., were supported by Harvard Catalyst | The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic healthcare centers. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Catalyst, Harvard University and its affiliated academic healthcare centers, or the National Institutes of Health. J.W.J., L.V., and S-L.N. and J.S. received support from Harvard Catalyst—The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Science Award UL1 TR001102). The authors assume full responsibility for the accuracy and completeness of the ideas presented.