Durairaj, Chandrasekar
Chakrabarti, Jayeta
Ferrario, Cristiano
Hirte, Holger W.
Babu, Sunil
Piha-Paul, Sarina A.
Plotka, Anna
Hoffman, Justin
Shi, Haihong
Wang, Diane D.
Funding for this research was provided by:
Pfizer
Article History
Accepted: 27 December 2020
First Online: 9 March 2021
Declarations
:
: This study was sponsored by Medivation, which was acquired by Pfizer in September 2016.
: Chandrasekar Durairaj, Jayeta Chakrabarti, Anna Plotka, Justin Hoffman, Haihong Shi, and Diane D. Wang are employees of Pfizer and receive stock and stock options as part of their employment. Cristiano Ferrario has received consulting fees from Astellas, Bayer, Eli Lilly, Novartis, Pfizer, and Roche, and research funding from Astellas, AstraZeneca, Merck, Novartis, Pfizer, Roche/Genentech, Sanofi, Seattle Genetics, and Zymeworks. Holger W. Hirte has no disclosures to declare. Sunil Babu has received honoraria from Alexion Pharmaceuticals, AstraZeneca, Bayer, Bristol-Myers Squibb, and Lilly; consulting fees from Alexion Pharmaceuticals, Argenx, AstraZeneca, Boehringer Ingelheim, and Bristol-Myers Squibb; speaker fees from Alexion Pharmaceuticals; research/grant funding (through his institution) from Abbvie, Alexion Pharmaceuticals, Amgen, Argenx, AstraZeneca/Medimmune, Bristol-Myers Squibb, Genentech/Roche, Janssen Oncology, Lilly, Merck, Nektar, Novartis, Sanofi, Syndax, and TG Therapeutics; and travel/accommodation expenses from Alexion Pharmaceuticals, Bristol-Myers Squibb, and Lilly. Sarina A. Piha-Paul has received research/grant funding (through her institution) from AbbVie, Inc., Alkermes, Aminex Therapeutics, Amphivena Therapeutics, Inc., BioMarin Pharmaceutical, Inc., Boehringer Ingelheim, Bristol Myers Squib, Cerulean Pharma Inc., Chugai Pharmaceutical Co., Ltd, Curis, Inc., Daichi Sanko, Eli Lilly, Five Prime Therapeutics, Genmab A/S, GlaxoSmithKline, Helix BioPharma Corp., Incyte Corp., Jacobio Pharmaceuticals Co., Ltd, Medimmune, LLC., Medivation, Inc., Merck Sharp and Dohme Corp., NewLink Genetics Corporation/Blue Link Pharmaceuticals, Novartis Pharmaceuticals, Pieris Pharmaceuticals, Inc., Pfizer, Principia Biopharma, Inc., Puma Biotechnology, Inc., Rapt Therapeutics, Inc., Seattle Genetics, Taiho Oncology, Tesaro, Inc., TransThera Bio, and XuanZhu Biopharma. NCI/NIH Core Grant, P30CA016672 (CCSG Shared Resources).
: The study protocol was conducted in accordance with the International Conference on Harmonisation Guidelines for Good Clinical Practice and the Declaration of Helsinki. The protocol also complied with the laws and regulations, as well as any applicable guidelines, of the countries where the study was conducted. The protocol was approved by the Independent Ethics Committee or Institutional Review Board at each of the investigational centers participating in the study.
: All patients provided written informed consent prior to undergoing any study-specific procedure.
: Not applicable.
: Upon request, and subject to certain criteria, conditions, and exceptions (seeExternalRef removedfor 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.
: Not applicable.
: All authors contributed to the design of the study and/or assisted with the data analysis/interpretation of the data. All authors assisted in the preparation of the manuscript, reviewed the manuscript, and provided their approval for submission. All authors agree to be accountable for all aspects of the work presented.