Lammers, Philip E.
Dank, Magdolna
Masetti, Riccardo
Abbas, Richat
Hilton, Fiona
Coppola, Jennifer
Jacobs, Ira
Article History
Received: 31 August 2017
Revised: 26 April 2018
Accepted: 25 May 2018
First Online: 13 July 2018
Ethics approval and consent to participate
: The study was conducted in compliance with the provisions of the Declaration of Helsinki and in accordance with international standards of Good Clinical Practice. All patients provided informed consent prior to undergoing screening procedures. The final protocol, amendments and informed consent documentation were reviewed and approved by an institutional review board or independent ethics committee(s) at each of the participating investigational sites.
: This study was funded by Pfizer Inc.
: Philip E. Lammers has participated on advisory boards with Pfizer Inc. Magdolna Dank has been a member of Biosimilars Oncology European Advisory Board with Pfizer Inc since 2013. Riccardo Masetti declares no conflicts of interest. Richat Abbas, Fiona Hilton, Jennifer Coppola and Ira Jacobs are full time employees of and declare stock holdings and/or stock options from Pfizer Inc.
: Pfizer’s policies on the provision of clinical trial data are set out on our website: ExternalRef removed. In addition to posting clinical trial results on the ClinicalTrials.gov registry, Pfizer will provide access to anonymised patient-level data in response to scientifically valid research protocols. Data from Pfizer-sponsored global interventional clinical studies are available from: trials conducted for medicines, vaccines and medical devices for indications that have been approved in the US and/or EU; trials conducted for medicines, vaccines and medical devices that have been terminated (i.e., development for all indications has been discontinued). Data from these trials will be made available 24 months after study completion. Pfizer will make reasonable efforts to fulfil all data requests for legitimate research purposes, but there may be instances in which retrieval or delivery of data is not feasible (for example, if Pfizer does not have legal authority to provide the data, if costs of retrieval of older or pre-electronic data are prohibitive, etc. See page 5* at the following link: ExternalRef removed). Further detail can be found at: ExternalRef removed. Pfizer’s practices adhere to the principles for responsible data sharing laid out by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA): ExternalRef removed.