Roberts, Corran
Strauss, Victoria Y.
Kopijasz, Sylwia
Gourley, Charlie
Hall, Marcia
Montes, Ana
Abraham, Jacinta
Clamp, Andrew
Kennedy, Richard
Banerjee, Susana
Folkes, Lisa K.
Stratford, Michael
Nicum, Shibani
Article History
Received: 29 November 2018
Revised: 4 October 2019
Accepted: 15 November 2019
First Online: 9 December 2019
Ethics approval and consent to participate
: The appropriate ethical guidelines and legislation were observed in conducting the 6MP study; namely, the study complied with the ethical principles of the Declaration of Helsinki (1996) and the regulatory requirements for clinical trials of an IMP under the European Union Clinical Trials Directive. Subjects provided their informed consent to participate in the study. The study was approved by the National Research Ethics Committee South Central–Oxford B (REC reference 10/H0605/79).
: All authors consent for publication.
: The datasets used and/or analysed during this study are available from the corresponding author on reasonable request with permission of 6MP trial management group committee.
: S.N. has received honoraria from AstraZeneca, Tesaro, Clovis and Roche and has provided consultancy for AstraZeneca, Clovis, Tesaro and Roch, and has received research funding from AstraZeneca. C.G. has received honoraria from AstraZeneca, Tesaro, Cor2Ed and Medscape; has provided consultancy for AstraZeneca, Clovis, Nucana, Tesaro, Roche, Foundation One and Cor2Ed; his institution receives research funding from AstraZeneca, Aprea AB, Nucana and Tesaro. R.K. receives payment as medical director for Almac Diagnostics. J.A. has received honorarium in the past 24 months, which has included travel expenses for advisory roles from Novartis and Genomic Health. S.B. has received research funding from Astrazeneca and has served on advisory boards for Astrazeneca, Tesaro and Clovis. All other authors jointly declare that they have no competing interests.
: The trial was sponsored by the University of Oxford, with funding from Cancer Research UK’s Clinical Trials Award and Advisory Committee (CTAAC) who approved a full funding application on 26th October 2010 (grant no: C1488/A12447), and this work was supported by the Oxford Partnership Comprehensive Biomedical Research Centre with funding from the Department of Health’s National Institute of Health Research (NIHR) Biomedical Research Centre funding scheme. VS was funded by Cancer Research UK (grant no. C5527/A16895).