Fazio, Nicola
Kulke, Matthew
Rosbrook, Brad
Fernandez, Kathrine
Raymond, Eric
Clinical trials referenced in this document:
Documents that mention this clinical trial
Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib
https://doi.org/10.1007/s11523-020-00784-0
Documents that mention this clinical trial
Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib
https://doi.org/10.1007/s11523-020-00784-0
Funding for this research was provided by:
Pfizer
Article History
Accepted: 5 December 2020
First Online: 7 January 2021
Declarations
:
: This study was sponsored by Pfizer. Medical writing support was provided by Vardit Dror, PhD and Charles Cheng, MS, of Engage Scientific Solutions, and funded by Pfizer.
: Eric Raymond is a consultant for and has received grants for clinical trials from Ipsen, Novartis, Eli Lilly, and Pfizer. Matthew H. Kulke has participated on advisory boards for Ipsen and Novartis. Nicola Fazio has received honoraria from Pfizer; he has participated on advisory boards for Novartis, Pfizer, and Ipsen, Merck Serono, MSD, and AAA; and his institution has received research funds from Novartis and Merck Serono. Brad Rosbrook and Kathrine Fernandez are employees of and hold stock in Pfizer.
: Both studies were conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. In addition, all local regulatory requirements were followed, in particular those affording greater protection to the safety of study participant.
: Written informed consent was obtained from each patient (or the patient’s legally authorized representative) before the patient was admitted to the study.
: 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 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.
: Not applicable.
: All authors were involved in the study conception/design. Material preparation and analysis were performed by BR. All authors were involved in the interpretation of data. All authors contributed to the drafting of the manuscript and approved the final version.