Kolberg, Hans-Christian
Colleoni, Marco
Demetriou, Georgia Savva
Santi, Patricia
Tesch, Hans
Fujiwara, Yasuhiro
Tomasevic, Zorica
Hanes, Vladimir
Clinical trials referenced in this document:
Documents that mention this clinical trial
Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study
https://doi.org/10.1007/s40264-019-00886-3
Biosimilars
https://doi.org/10.1136/esmoopen-2018-000321
Funding for this research was provided by:
Amgen
Article History
First Online: 11 January 2020
Compliance with Ethical Standards
:
: Hans-Christian Kolberg received honoraria from Carl Zeiss Meditec, TEVA, Theraclion, Novartis, Amgen, Astra Zeneca, Pfizer, Janssen-Cilag, GSK, LIV Pharma, Roche and Genomic Health, and non-financial support from Carl Zeiss Meditec, Novartis, Pfizer, Amgen, Roche, LIV Pharma, Tesaro, Daiichi Sankyo, and Genomic Health. Marco Colleoni is a consultant for AstraZeneca, Celldex, Novartis, OBI Pharma, Pfizer, Pierre Fabre, and Puma Biotechnology, has received honoraria from Novartis, and is also an investigator on the ABP 980 LILAC Study. Georgia Savva Demetriou is a consultant for Astra Zeneca and Celgene, and was on speakers’ bureaus for Merck and Serono. Patricia Santi was an investigator on the ABP 980 LILAC Study, but has no other conflicts to declare. Hans Tesch received honoraria from Novartis, Roche, Celgene, Teva, and Pfizer, and travel support from Roche, Celgene, and Pfizer. Yasuhiro Fujiwara received lecture fees from AstraZeneca KK, Daiichi-Sankyo, Taiho, Chugai, Novartis Pharma KK, Bristol-Myers KK, SRL, and Santen Pharmaceutical. Zorica Tomasevic is a consultant for and received honoraria from Roche, Pfizer, and Novartis, has served on the speakers’ bureau for Pfizer, and has received travel support from Roche. Vladimir Hanes is an employee and stockholder of Amgen.
: This study was funded by Amgen, Inc., Thousand Oaks, CA, USA.
: The protocol was reviewed and approved by the relevant independent Ethics Committees for each center. All patients provided written informed consent. This study was conducted in accordance with the terms of the Declaration of Helsinki, Good Clinical Practice guidelines, and all applicable regulatory requirements.
: There is a plan to share data. This may include de-identified individual patient data for variables necessary to address the specific research question in an approved data-sharing request, as well as related data dictionaries, study protocol, statistical analysis plan, informed consent form, and/or clinical study report. Data-sharing requests relating to data in this article will be considered after the publication date and (1) this product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or (2) clinical development discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data-sharing request for these data. Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labeling. A committee of internal advisors reviews requests. If not approved, a Data Sharing Independent Review Panel may arbitrate and make the final decision. Requests that pose a potential conflict of interest or an actual or potential competitive risk may be declined at Amgen’s sole discretion and without further arbitration. Upon approval, information necessary to address the research question will be provided under the terms of a data-sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code, where provided, in analysis specifications. Further details are available at ExternalRef removed.