Document is current

Article History

Received: 14 January 2020

Accepted: 20 April 2020

First Online: 30 April 2020

Compliance with ethical standards

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: In the past 36 months, Dr. Shah has received research support through Mayo Clinic from the Food and Drug Administration to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI), from the Agency for Healthcare Research and Quality (R01HS025402; R03HS025517), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HL131535), National Science Foundation, and from the Patient Centered Outcomes Research Institute (PCORI) to develop a Clinical Data Research Network (LHSNet). Support to Dr. Jena was provided by the Office of the Director, National Institutes of Health (1DP5OD017897). Dr. Jena reports receiving consulting fees unrelated to this work from Pfizer, Hill Rom Services, Bristol Myers Squibb, Novartis, Amgen, Eli Lilly, Vertex Pharmaceuticals, AstraZeneca, Celgene, Tesaro, Sanofi Aventis, Biogen, Precision Health Economics, and Analysis Group. Dr. Ross has received research support through Yale University 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 Food and Drug Administration to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Blue Cross Blue Shield Association to better understand medical technology evaluation, 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), 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. Dr. Herrin has recieved additional support for unrelated research from the Centers for Medicare and Medicaid Services and Mayo Clinic. Mr. Everhart and Mr. Higuera are paid research fellows at Medtronic for unrelated Projects. Dr. Jeffery is supported by two Grants that funded this study (NIH/R56 HL130496 and Agency for Healthcare Research and Quality/R01 HS025164); by an American Cancer Society funded study on biosimilar drug uptake (131611-RSGI-17-154-01-CPHPS); by the CERSI (U01FD 05938) for a Project addressing unsafe prescribing of opioids subject to REMS; and by NHLBI for a Project on step-down of asthma biologics (R21HL 140287). She has additional unrelated funding from NCATS (UL1TR 02377) and NIDA (UG3DA047003). Dr. Karaca-Mandic serves as the Principal Investigator to Grants that funded this study (NIA/P01AG005842; NIH/R56 HL130496 and Agency for Healthcare Research and Quality/R01 HS025164). She is also the Principal Investigator to an American Cancer Society funded study on biosimilar drug uptake (131611-RSGI-17-154-01-CPHPS). In the past 36 months, she reports receiving consulting fees unrelated to this work from Tactile Medical and Precision Health Economics.