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Authors
Mikic, N.
Poulsen, F. R.
Kristoffersen, K. B.
Laursen, R. J.
Guldberg, T. L.
Skjøth-Rasmussen, J.
Wong, E. T.
Møller, S.
Dahlrot, R. H.
Sørensen, J. C. H.
Korshøj, A. R.
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Funding
Funding for this research was provided by:
novocure (1.300.644 USD)
danmarks frie forskningsfond (1.392.683 DKK)
sundhedsvidenskabelige fakultet, aarhus universitet (550.000 DKK)
kræftens bekæmpelse (1.700.000 DKK)
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Article History
Received: 10 July 2021
Accepted: 18 August 2021
First Online: 9 September 2021
Declarations
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: OptimalTTF-2 (NCT04223999) will comply with international guidelines Good Clinical Practice (<i>ICH-GCP and DS/EN ISO 14155:2012</i>) and be monitored by the GCP unit at Aarhus University. AE reporting procedures will comply with <i>Guidelines on medical devices. Clinical investigations: Serious adverse event reporting (MEDDEV 2.7/3)</i> and <i>Reporting of adverse reactions in clinical trials</i>. All data will be handled in accordance with <i>The Danish Act on Processing of Personal Data</i>. Clinical trial approval has been gained from the Central Denmark Region Committee of Health Research Ethics, The Danish Data Protection Agency, and the Danish Health Authorities for all sites.All patients will receive oral and written information by a certified neurosurgeon with time to consider enrollment in the trial. Based upon the written and oral information, they will give signed informed consent.
: Not applicable.
: None of the authors have any competing interests.
