Ethics approval and consent to participate
Country
|
City
|
Responsible Ethics Committee
|
Date of Submission
|
Date of EC approval
|
Austria
|
Graz
|
Ethics committee of the Medical University of Graz
Auenbruggerplatz 2
8036 Graz
|
02-Feb-2017
|
24-Mar-2017
|
France
|
Nantes
|
CPP OUEST IV
53, Chaussée de la Madeleine 44000 Nantes
|
27-Mar-2017
|
03-May-2017
|
Germany
|
Essen
|
Ethikkommission der Medizinischen Fakultät der Universität Duisburg-Essen
Robert-Koch-Str. 9-11
45147 Essen
|
17-Feb-2017
|
24-Apr-2017
|
Italy
|
Bologna
|
Comitato Etico dell’Istituto Ortopedico Rizzoli via G.C. Pupilli, 1 40136 Bologna
|
06-Oct-2016
|
14-Dec-2016
|
Italy
|
Milano
|
Comitato Etico della Fondazione IRCCS Istituto Nazionale dei Tumori
Via Venezian 1
20133 Milano
|
20-Oct-2016
|
23-Nov-2016
|
Spain
|
Barcelona
|
Comité Ético de Investigación Clínica Hospital de la Santa Creu i Sant Pau
Sant Antoni Ma Claret, 167
08025 Barcelona
|
02-Feb-2017
|
22-Mar-2017
|
Spain
|
Sevilla
|
Unidad de Gestión de Ensayos Clínicos, Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla Hospital Universitario Virgen Macarena
Avda. Dr. Fedriani, 3
41071 Sevilla
|
02-Feb-2017
|
20-Mar-2017
|
The Netherlands
|
Nijmegen
|
Concernstaf Kwaliteit en Veiligheid
Commissie Mensgebonden Onderzoek
Geert Grooteplein (route 629),
Nijmegen
|
24-Nov-2016
|
19-Dec-2016
|
The Netherlands
|
Leiden
|
Commissie Medische Ethiek LUMC
Albinusdreef 2 2333 ZA Leiden
|
06-Sep-2016
|
15-Nov-2016
|
United Kingdom
|
London
|
London - Hampstead Research Ethics Committee
Barlow House
4 Minshull Street
Manchester M1 3DZ
|
30-Jan-2017
|
23-Mar-2017
|
United Kingdom
|
Oxford
|
London - Hampstead Research Ethics Committee
Barlow House
4 Minshull Street
Manchester M1 3DZ
|
30-Jan-2017
|
23-Mar-2017
|
United States of America
|
Los Angeles
|
UCLA Institutional Review Board
University of California Los Angeles
10889 Wilshire Blvd, Suite 830
Los Angeles, CA 90095-1406
|
20-Dec-2017
|
30-May-2018
|
United States of America
|
New York
|
IRB Memorial Sloan-Kettering Cancer Center
1275 York Avenue
New York 10065
|
08-Jan-2018
|
23-Jan-2018
|
This non-interventional study was conducted according to the Declaration of Helsinki (October 2013) and Good Clinical Practice guidelines of the International Conference on Harmonisation. This study is registered with ClinicalTrials.gov (number NCT02948088), and the institutional review board at each participating center approved the study.
Consent for publication
All patients provided written consent.
Availability of data and materials
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/ourmember/daiichi-sankyo/
Competing interests
NMB reports consulting fees from Daiichi Sankyo, Zimmer Biomet, and Onkos Surgical. GS reports research funding to his institution (LUMC) from Daiichi Sankyo. JHH reports consulting fees from Daiichi Sankyo. SS reports consulting fees from Bayer, Bavarian Nordic, Deciphera, Eli Lilly, Epizyme Inc, Daiichi Sankyo, Karyopharm, Immune Design, Intellisphere, Maxivax, PharmaMar, and Takeda; research funding to her institution from Amgen Dompé, Advenchen, Bayer, Bavarian Nordic, Blueprint, Deciphera, Eli Lilly, Epizyme Inc, Daiichi Sankyo, Karyopharm, Novartis, Pfizer, and PharmaMar; and travel coverage from PharmaMar. EP served on an advisory board for Amgen, Daiichi Sankyo, Lilly, Eusa Pharma, Deciphera; research funding from Bristol-Myers Squibb, Pfizer, PharmaMar, and travel support from Lilly, PharmaMar, and Takeda. SB reports advisory board fees for Deciphera, Blueprint Medicines, ADC Therapeutics, Nanobiotix, Bayer, Lilly, Novartis, Exelixis, Daiichi Sankyo, and Roche; CME honoraria from PharmaMar, Lilly, and Novartis; research funding from Incyte, Blueprint Medicines, and Novartis; and travel support from PharmaMar. HG reports research funding to his institution (LUMC) from Daiichi Sankyo. ELS has served on a steering committee for Daiichi Sankyo Europe GmbH and an advisory board for Daiichi Sankyo Inc. JLB declares no competing interests. EMF, PL, and XY are employees are Daiichi Sankyo. MAJvdS reports research funding from Daiichi Sankyo. The TOPP Study Group reports the following conflicts of interests: BS reports limited research administrative compensation from Daiichi Sankyo; AL reports institution education grants from Johnson and Johnson, Alphamed, and Globus; JMB reports research funding from Lilly, PharmaMar, Eisai, Novartis, GSK, LIXTE, Karyopharm, Celgene, Pfizer, BMS, Blueprint, Deciphera, Nektar, Forma, Amgen, and Daiichi Sankyo; FG reports consulting fees from Amgen, stock ownership in Atlanthera, and honoraria from Deciphera; ALP and TC declare no competing interests.
Funding
The Department of Orthopaedics of the Leiden University Medical Center receives research funding from Daiichi Sankyo. This research was also funded in part by a grant to Memorial Sloan Kettering from the National Institutes of Health/National Cancer Institute (#P30 CA008748). Employees of the funder participated in the study design and conduct and were involved in collection, analysis, and interpretation of the data.
Authors’ contributions
GS, NMB, JHH, PL, SS, EP, ELS and MAJvdS were responsible for the conception and design of the study. NMB, JHH, SS, EP, ELS, the TOPP Study Group, and MAJvdS collected the data. EMF assembled the data and performed the statistical analysis. GS, NMB, JHH, PL, EMF, SS, EP, ELS, and MAJvdS interpreted the data. GS drafted the manuscript, after which NMB, JHH, SS, EP, SB, HG, ELS, JLB, and MAJvdS revised the manuscript with important intellectual content. GS, NMB, JHH, SS, EP, SB, HG, ELS, JLB, EMF, XY, PL, and MAJvdS all reviewed and approved the final version of the manuscript before submission.
The corresponding authors take responsibility for the integrity of work, from inception to published article. The TOPP Study Group consists of contributors taking part in the steering committee and/or responsible for patient inclusion and data collection. The TOPP Study Group members all have reviewed and approved the final version of the manuscript.
Acknowledgements
The authors wish to thank the TOPP Study Group, including Bart Schreuder, Department of Orthopaedic Oncology, Radboud University, Nijmegen, Netherlands; Andreas Leithner, Department of Orthopaedics and Trauma, Medical University of Graz, Graz, Austria; Javier Martin-Broto, Seville Institute of Biomedicine, Virgen del Rocio Univeristy Hospital, Sevilla, Spain; Francois Gouin, Orthopedic and Trauma Surgery, CHU de Nantes, Nantes, France; Antonio Lopez Pousa, Medical Oncology Department, Hospital Sant Pau, Barcelona, Spain; and Thomas Cosker, Nuffield Orthopaedic Centre, Oxford, United Kingdom, for their patient inclusion and data collection. Medical writing support and editorial assistance in the development of the article were provided by Phillip Giannopoulos, PhD of SciStrategy Communications, and funded by Daiichi Sankyo, Inc.