Wang, Erjian
DuBois, Steven G.
Wetmore, Cynthia
Verschuur, Arnauld C.
Khosravan, Reza http://orcid.org/0000-0002-4181-8728
Funding for this research was provided by:
Pfizer
Article History
Accepted: 22 January 2021
First Online: 14 April 2021
Declarations
:
: This study was sponsored by Pfizer.
: EW and RK are employees of Pfizer and hold stock or stock options with Pfizer. SGD has received travel expenses from Roche, Salarius, and Loxo Oncology, and consulting fees from Bayer and Loxo Oncology. CW has received research support and prior travel expenses from Eli Lilly & Co, and is an employee Exelixis Inc and holds stock or stock options with Exelixis Inc. ACV is a consultant for Pfizer.
: The original clinical trials were conducted in accordance with the Declaration of Helsinki and all local regulatory requirements, and in compliance with Good Clinical Practice Guidelines from the International Conference on Harmonization.
: All patients or their parent or legal guardian provided written informed consent prior to participating in the original clinical trials.
: Not applicable.
: 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.
: Not applicable.