Rosen, Lee S.
Wesolowski, Robert
Baffa, Raffaele
Liao, Kai-Hsin
Hua, Steven Y.
Gibson, Brenda L.
Pirie-Shepherd, Steven
Tolcher, Anthony W.
Funding for this research was provided by:
Pfizer (N.A.)
Article History
Received: 10 October 2018
Accepted: 1 March 2019
First Online: 18 March 2019
Compliance with ethical standards
:
: L. S. Rosen and A. W. Tolcher received research funding from Pfizer. R. Wesolowski served on an advisory board for Pfizer. R. Baffa, K-H. Liao, S. Y. Hua, B. L. Gibson, and S. Pirie-Shepherd were employees of Pfizer during the conduct of this study.
: All procedures performed in this study 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.
: Informed consent was obtained from all individual participants included in the study.
: 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 US 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.