Nayak, Satyaprakash http://orcid.org/0000-0001-7225-1317
Tammara, Brinda http://orcid.org/0000-0002-0423-1856
Harnisch, Lutz O. http://orcid.org/0000-0002-4085-1577
Funding for this research was provided by:
Pfizer Inc.
Article History
Accepted: 12 April 2021
First Online: 16 May 2021
Declarations
:
: This study was funded by Pfizer Inc.
: Satyaprakash Nayak, Brinda Tammara, and Lutz O. Harnisch are employees of Pfizer and may own stock/options in the company.
: All studies included in this analysis were approved by an institutional review board or ethics committee at each study center and were conducted in accordance with the principles of the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice guidelines, and local regulatory requirements.
: In all studies, all patients provided written informed consent prior to participation.
: 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 European Union 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.
: All authors contributed to the study conception and design. All authors collaborated in the preparation of the manuscript, with editorial support funded by Pfizer Inc., and critically reviewed and provided revisions to the manuscript. All authors had access to the data and assume responsibility for the completeness and accuracy of the data and data analyses. All authors granted final approval of the manuscript for submission.