Yao, Hsuan-Ming http://orcid.org/0000-0002-1652-2749
Ottery, Faith D.
Borema, Troy
Harris, Stuart
Levy, Jeffrey
May, Tom B.
Moosavi, Shahrzad
Zhang, Jeffrey
Summers, Martin
Funding for this research was provided by:
Pfizer
Article History
First Online: 21 March 2019
Compliance with Ethical Standards
:
: This work was funded by Hospira Inc, which was acquired by Pfizer Inc in September 2015, and by Pfizer Inc. Open access publication of this article was funded by Pfizer Inc.
: TBM, SM, MS, H-MY, and JZ are employees of and own stock or options in Pfizer Inc. FDO was an employee of and held stock or options in Pfizer Inc at the time of study conduct. TB, SH, and JL are employees of Quotient Sciences, formerly Seaview Research Inc., which received funding from Pfizer Inc to perform the studies described in the manuscript.
: The protocol and all amendments for each study were approved by the institutional review board at each of the investigational centers participating in the studies. All studies were conducted in compliance with the protocol, International Conference on Harmonization guidelines, all applicable regulatory requirements, and the Declaration of Helsinki. Subjects provided written informed consent prior to the performance of any study-specific procedures. Volunteers were free to withdraw from the study at any time.
: 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.