Patel, Maulik
Chen, Joseph
McGrory, Stephanie
O’Gorman, Melissa
Nepal, Sunil
Ginman, Katherine
Pithavala, Yazdi K.
Funding for this research was provided by:
Pfizer (N/A)
Article History
Received: 11 October 2019
Accepted: 17 October 2019
First Online: 14 November 2019
Compliance with ethical standards
:
: MP is an employee of AbbVie Inc. and owns stock in AbbVie Inc.JC is an employee of Pfizer Inc. and owns stock in Pfizer Inc.SM is an employee of Pfizer Inc. and owns stock in Pfizer Inc.MO is an employee of Pfizer Inc.SN is an employee of Pfizer Inc.KG is an employee of Pfizer Inc.YKP is an employee of Pfizer Inc. and owns stock in Pfizer Inc.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Ethics Committee of Erasme Hospital, Anderlecht, Belgium) 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 deidentified 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 deidentified 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.