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Article History

Received: 9 October 2020

Revised: 26 April 2021

Accepted: 13 May 2021

First Online: 25 May 2021

Ethics approval and consent to participate

: The study received ethics approval from the Joint University College London and University College London Hospital committees of ethics of human research (99/0307). The study was performed in accordance with the declaration of Helsinki.

: Not applicable.

: Not applicable.

: J.S.V. has received a research grant from Photoelectron Corp (1996–99) and from Carl Zeiss for supporting data management at the University of Dundee (Dundee, UK, 2004-2008) and has received honoraria. J.S.V., J.S.T., N.W., I.P., C.B.-G. and N.R. receive funding from HTA, NIHR, Department of Health for some activities related to the TARGIT trials. M.Ba. was briefly on the scientific advisory board of Carl Zeiss and was paid consultancy fees before 2010. F.W. has received a research grant from Carl Zeiss for supporting radiobiological research. Carl Zeiss sponsors some of the travel and accommodation for meetings of the international steering committee and data monitoring committee and when necessary for conferences where a presentation about targeted intraoperative radiotherapy is being made for all authors apart from WE who declares that he has no conflicts of interest. The remaining authors declare no competing interests.

: The study was sponsored by University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre. Funding was provided by UCLH Charities, National Institute for Health Research (NIHR) Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research (BMBF) FKZ 01ZP0508. The infrastructure of the trial operations office in London, UK, was supported by core funding from Cancer Research Campaign (now Cancer Research UK) when the trial was initiated. The funding organisations had no role in the concept, design, analysis or writing of the manuscript.

: UCL is supportive of data sharing and will endeavour to assist in requests for data sharing. All requests for data sharing will adhere to the UCL Surgical & Interventional Trials Unit (SITU) data-sharing agreement policy. These data will be held at UCL on secure servers and cannot be released to any third parties. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate security and privacy agreements, and acknowledgement of the TARGIT Trialists’ Group, investigators, the sponsor and funders.