Smith, Meredith Y. http://orcid.org/0000-0003-4542-5099
Morrato, Elaine H.
Mora, Nallely
Nguyen, Viviana
Pinnock, Hilary
Winterstein, Almut G.
Funding for this research was provided by:
National Center for Advancing Translational Sciences (2UL1TR002389)
Article History
Accepted: 26 February 2024
First Online: 13 March 2024
Declarations
:
: EHM’s effort was supported in part by the National Center for Advancing Translational Science of the National Institutes of Health under award number 2UL1TR002389. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. No other financial support was received.
: MYS is a fulltime employee of Evidera, a consultancy that performs healthcare research for a wide range of biopharmaceutical and biotechnology companies, and is a shareholder in Thermo Fisher Scientific, which owns PPD. She is also an adjunct faculty member in the Department of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, Los Angeles, CA, USA. VN and NM have no conflicts of interest to report. EHM has received funding over the past three years for consulting services on issues of drug safety from Eli Lilly, Health Care Service Corporation, Inc., i2o, Humana Inc., Ipsen, Molina Healthcare, Inc., Reata Pharmaceuticals, Syneos Health, and United Healthcare Services. HP receives grant monies paid to her institution for applied and implementation research unrelated to risk minimization program evaluations. In the past three years she has received speaker fees from Teva and Sandoz for non-promotional talks unrelated to topics covered in this paper. AGW has received consulting fees from Bayer KG, Genentech Inc, Arbor Pharmaceuticals, and Ipsen, and has received research funding from Merck, Sharp and Dohme.
: Ethical review was conducted by the Advarra Institutional Review Board (IRB), Columbia, MD, USA. For the United States (US) and Western Europe, the project was deemed to be exempt from IRB review (May 18, 2023; Pro00071189); for Canada, ethics approval was granted on May 24, 2023 (Pro00071646).
: Not applicable.
: Not applicable.
: Available upon request to the corresponding author.
: Not applicable.
: MYS designed the study, analysis, wrote the first draft of the manuscript, and prepared the final draft for submission. NM conducted statistical analysis of the e-Delphi data, prepared the e-Delphi results tables, and reviewed the final draft of the manuscript. VN prepared the tables and assisted in reviewing and revising the manuscript. HP, AGW, and EHM assisted in the study design, the conduct of the data analysis, and reviewed the final draft of the manuscript. All authors read and approved the final version. This manuscript has been endorsed by the International Society for Pharmacoepidemiology.