Dhruva, Sanket S. http://orcid.org/0000-0003-0674-2032
Ross, Joseph S. http://orcid.org/0000-0002-9218-3320
Akar, Joseph G.
Caldwell, Brittany
Childers, Karla
Chow, Wing
Ciaccio, Laura http://orcid.org/0000-0002-9961-3151
Coplan, Paul http://orcid.org/0000-0002-7078-7780
Dong, Jun
Dykhoff, Hayley J. http://orcid.org/0000-0003-1150-3351
Johnston, Stephen
Kellogg, Todd
Long, Cynthia
Noseworthy, Peter A.
Roberts, Kurt
Saha, Anindita
Yoo, Andrew
Shah, Nilay D.
Funding for this research was provided by:
U.S. Department of Health & Human Services | U.S. Food and Drug Administration (U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938, U01FD005938)
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
U.S. Department of Health & Human Services | U.S. Food and Drug Administration
Article History
Received: 7 November 2019
Accepted: 23 March 2020
First Online: 20 April 2020
Competing interests
: S.S.D. currently receives research support through the National Institute of Health (K12HL138046) and The Greenwall Foundation. J.S.R. formerly received research support through Yale University 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 (HHSM-500-2013-13018I), and from the Blue Cross Blue Shield Association to better understand medical technology evaluation; J.S.R. currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency (CRIT) at Yale. In the past 36 months, N.D.S. has received research from the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI), from the Agency for Healthcare Research and Quality (R01HS025164; R01HS025402; 1U19HS024075; R03HS025517), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R56HL130496; R01HL131535), National Science Foundation, and from the Patient-Centered Outcomes Research Institute (PCORI) to develop a Clinical Data Research Network (LHSNet). P.C., A.Y., S.J., and K.C. are employees and stockholders of Johnson & Johnson; W.C. is an employee of Janssen Scientific Affairs, LLC, and a stockholder of Johnson & Johnson.