Straub, Loreen http://orcid.org/0000-0003-2623-2726
Gagne, Joshua J.
Maro, Judith C.
Nguyen, Michael D.
Beaulieu, Nicolas
Brown, Jeffrey S.
Kennedy, Adee
Johnson, Margaret
Wright, Adam
Zhou, Li
Wang, Shirley V.
Funding for this research was provided by:
U.S. Food and Drug Administration (HHSD22301002T)
Article History
First Online: 20 May 2019
Compliance with Ethical Standards
:
: Joshua J. Gagne has received salary support from grants from Eli Lilly and Company and Novartis Pharmaceuticals Corporation to the Brigham and Women’s Hospital and is a consultant to Aetion, Inc. and Optum, Inc., all for unrelated work. Shirley V. Wang receives salary support from investigator-initiated grants from Novartis, J & J, and Boehringer Ingelheim to the Brigham and Women’s Hospital and is a consultant to Aetion, Inc., all for unrelated work. Loreen Straub, Judith C. Maro, Michael D. Nguyen, Nicolas Beauileu, Jeffrey S. Brown, Adee Kennedy, Margaret Johnson, Adam Wright and Li Zhou declare that they have no conflict of interest.
: The Sentinel System is sponsored by the US Food and Drug Administration (FDA) to proactively monitor the safety of FDA-regulated medical products and complements other existing FDA safety surveillance capabilities. The Sentinel System is one piece of FDA’s Sentinel Initiative, a long-term, multi-faceted effort to develop a national electronic system. Sentinel Collaborators include Data and Academic Partners that provide access to healthcare data and ongoing scientific, technical, methodological, and organizational expertise. The Sentinel Coordinating Center is funded by the FDA through the Department of Health and Human Services (HHS) Contract number HHSF223201400030I. This project was funded by the FDA through HHS Mini-Sentinel contract number HHSD22301002T. This article reflects the views of the authors and should not be construed to represent FDA’s views or policies.
: This article presents information collected via semi-structured interviews with organizations who agreed to participate in this project and does not contain any active studies with human participants or animals performed by any of the authors.