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Authors
Kasper, Stefan http://orcid.org/0000-0002-5947-8733
Kisro, Jens
Fuchs, Martin
Müller, Christian
Schulz-Abelius, Armin
Karthaus, Meinolf
Rafiyan, Mohammad-Reza
Stein, Alexander
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Funding
Funding for this research was provided by:
Servier
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Article History
Received: 17 November 2017
Accepted: 7 November 2018
First Online: 16 November 2018
Ethics approval and consent to participate
: According to the regulations of the German Medicinal Product Act (AMG §21 subsection 2 no. 6), there was no need for an ethics approval in regard to the compassionate-use-program (CUP) for FTD/TPI (Lonsurf®). Therefore, this program was not submitted to the ethics committee but reported to the German Federal Institute for Drugs and Medical Devices (BfArM). Patients were informed by the investigators about the CUP and had to sign an informed consent form (ICF) before beeing enclosed into the program. The ICF will be made available from the correponding author upon request.
: The informed consent form from Servier Deutschland GmbH contained a text passage “Confirmation of Use of Personal Medical Records and Personal Information” and each mCRC patient of the CUP for FTD/TPI (Lonsurf®) agreed to the processing of pseudonymized personal data.
: SK received authorship remuneration from SERVIER Deutschland GmbH (Germany). All other authors declare no competing interests.
: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
