Striha, Alina
Ashcroft, A. John
Hockaday, Anna
Cairns, David A.
Boardman, Karen
Jacques, Gwen
Williams, Cathy
Snowden, John A.
Garg, Mamta
Cavenagh, Jamie
Yong, Kwee
Drayson, Mark T.
Owen, Roger
Cook, Mark
Cook, Gordon http://orcid.org/0000-0003-1717-0412
Funding for this research was provided by:
Cancer Research UK ((A19272) CRUK/15/008)
Takeda Development Center Americas, Inc. (IISR-2013-M100147)
Article History
Received: 18 December 2017
Accepted: 18 January 2018
First Online: 7 March 2018
Ethics approval and consent to participate
: The trial has been approved by a main Research Ethics Committee (Main REC) and the appropriate local R&D department for each participating centre prior to opening to participant recruitment into the trial. Ethical approval has been obtained from the National Research Ethics Service Committee - North West, Greater Manchester (reference 16/NW/0517).The trial will be performed in accordance with the recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964, amended at the 52nd World Medical Association General Assembly, Edinburgh, Scotland, 2000, principles of Good Clinical Practice in clinical trials, as applicable under UK regulations, the NHS Research Governance Framework (and Scottish Executive Health Department Research Governance Framework for Health and Social Care 2006 for studies conducted in Scotland) and through adherence to CTRU Standard Operating Procedures (SOPs). Additionally, CTRU and the Sponsor have systems in place to ensure that serious breaches of GCP or the trial protocol are picked up and reported.Informed written consent will be obtained from the participants prior to registration into the trial. The right of a participant to refuse participation without giving reasons must be respected. The participant must remain free to withdraw at any time from the trial without giving reasons and without prejudicing his/her further treatment.
: Consent for publication is not applicable, as an individual person’s data is not part of the ACCoRd study.
: AJA provides consultancy for Celgene, Janssen, Takeda; receives honoraria from Celgene, Amgen, Janssen, Takeda; is part of the Speakers Bureau for Celgene, Amgen, Janssen, Takeda; AH has research funding from Takeda, Celgene, Janssen, Amgen, Merck Sharp & Dohme; AS has research funding from Takeda, Celgene, Janssen, Amgen, Merck Sharp & Dohme; CW receives honoraria from Takeda, Janssen, Celgene, Amgen, Novartis; is part of the Speakers Bureau for Takeda, Celgene, Janssen, Amgen; receives travel support from Takeda, Janssen, Celgene; DC has research funding from Takeda, Celgene, Janssen, Amgen, Merck Sharp & Dohme; GC provides consultancy for Takeda, Janssen, Sanofi, Amgen, Glycomimetics; receives research funding from Takeda, Celgene, Janssen; is part of the Speakers Bureau for Takeda, Janssen, Sanofi, Amgen; GJ has research funding from Takeda, Celgene, Janssen, Amgen, Merck Sharp & Dohme; JC is involved with honoraria/Speakers Bureau for Celgene, Janssen, Novartis, Amgen; JS provides consultancy for Kiadis; receives honoraria from Sanofi-Genzyme, Jazz; KB has research funding from Takeda, Celgene, Janssen, Amgen, Merck Sharp & Dohme; KY has research funding from Janssen, Amgen; receives honoraria from Janssen, Amgen; MC has research funding from Celgene, Janssen; is involved with honoraria/Speakers Bureau for Takeda, Celgene, Janssen, Amgen, Chugai; MD is a consultant to and shareholder of Abingdon Health Limited; RO receives honoraria from Takeda, Celgene; has research funding from Celgene; provides consultancy for Celgene, Janssen; receives travel support from Takeda, Janssen.
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