Baker, Joshua F.
Bakewell, Catherine
Dikranian, Ara
Lam, Gordon
O’Brien, Jacqueline
Moore, Page C.
Yu, Miao
Hur, Peter
Masri, Karim R. http://orcid.org/0000-0002-2178-9747
Funding for this research was provided by:
Pfizer
Article History
Received: 11 December 2023
Accepted: 7 February 2024
First Online: 20 March 2024
Declarations
:
: Joshua Baker has received consulting fees from Bristol Myers Squibb, CorEvitas, Cumberland Pharma, Burns White, and LLC, and has received grant funding from Horizon. Catherine Bakewell is a speaker/consultant for AbbVie, Janssen, Lilly, Novartis, Pfizer, Sanofi/Genzyme, and UCB. Ara Dikranian is a speaker/consultant for AbbVie, Amgen, Eli Lilly, Janssen, Sanofi, Pfizer, and UCB. Gordon Lam is a speaker/consultant for AbbVie, Bristol Myers Squibb, Janssen, Novartis, Pfizer, Sanofi/Genzyme, and UCB. Jacqueline O’Brien, Page C. Moore, and Miao Yu are employees of CorEvitas, LLC, and were contracted by Pfizer to provide data, input into design of data collection and statistical support for the development of the manuscript. Karim R. Masri and Peter Hur are employees and shareholders of Pfizer.
: The study was performed in accordance with the Declaration of Helsinki and the Guidelines for Good Pharmacoepidemiology Practice (GPP). All participating investigators were required to obtain full board approval for conducting noninterventional research involving human subjects with a limited dataset. Sponsor approval and continuing review was obtained through a central institutional review board (IRB), the New England Independent Review Board (NEIRB; no. 120160610). For academic investigative sites that did not receive authorization to use the central IRB, full board approval was obtained from their respective governing IRBs, and documentation of approval was submitted to CorEvitas, LLC before the site’s participation and initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization before participating.