De Rosa, Francesco Giuseppe http://orcid.org/0000-0001-8338-0130
Busca, Alessandro
Capparella, Maria Rita
Yan, Jean Li
Aram, Jalal A.
Funding for this research was provided by:
Pfizer Inc
Università degli Studi di Torino
Article History
Accepted: 6 March 2021
First Online: 23 April 2021
Declarations
:
: Open access funding provided by Università degli Studi di Torino within the CRUI-CARE Agreement. This study was sponsored by Pfizer Inc.
: FDR has received speaker grants and participated in advisory boards for Angelini, Basilea, Biomereuix, BioTest, Correvio, Gilead Sciences, Hikma, MSD, Nordic Pharma, Sanofi Aventis, Pfizer Inc, and ThermoFisher. AB has received honoraria from Gilead Sciences, Jazz Pharmaceuticals, Merck, and Pfizer Inc; he has been speaker for Gilead Sciences, Merck, Novartis, and Pfizer Inc, and has served on Advisory Boards for Gilead Sciences and Pfizer Inc. JAA, JLY, and MRC are employees and shareholders of Pfizer Inc.
: Conduct was in accordance with applicable legal and regulatory requirements, the International Conference on Harmonization Guidelines for Good Clinical Practice, and the Declaration of Helsinki. The Institutional Review Boards or Independent Ethics Committees at each investigational center approved the studies.
: All patients provided written informed consent.
: 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.