Zheng, Jenny
Yu, Yanke
Durairaj, Chandrasekar http://orcid.org/0000-0001-9212-7436
Diéras, Véronique http://orcid.org/0000-0002-8798-6540
Finn, Richard S. http://orcid.org/0000-0003-1597-5903
Wang, Diane D.
Article History
First Online: 19 November 2020
Declarations
:
: This study was sponsored by Pfizer Inc.
: V.D. has served as a consultant/advisor for Pfizer, Roche, Genentech, Eli Lilly, Novartis, AbbVie, AstraZeneca, MSD, Daiichi Sankyo, and Seattle Genetics; served on the speakers bureau for Pfizer, Roche, Eli Lilly, AstraZeneca, Daiichi Sankyo, and Novartis; and received travel, accommodation, and expenses from Roche, Novartis, Pfizer, Eli Lilly, and AstraZeneca. R.S.F. has a consultant advisory role with Pfizer, Bayer, Novartis, and Bristol Myers Squibb and receives research funding from Pfizer. J.Z., Y.Y., C.D., and D.D.W. are employees and shareholders of Pfizer.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: For this type of study, formal consent is not required.
: For this type of study, formal consent is not required.
: Upon request, and subject to certain criteria, conditions and exceptions (see ExternalRef removed for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the USA and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
: N/A.
: V.D, R.S.F., J.Z., Y.Y., C.D., and D.D.W. participated in the study design, data collection, and analysis and interpretation of data. J.Z. wrote the first draft of the manuscript. All authors provided significant input into the manuscript and have read and approved the final draft for submission.