Clement, Dominique http://orcid.org/0000-0002-8116-962X
Navalkissoor, Shaunak
Srirajaskanthan, Rajaventhan http://orcid.org/0000-0001-9835-8681
Courbon, Frédéric http://orcid.org/0000-0002-1279-2362
Dierickx, Lawrence http://orcid.org/0000-0002-5274-4138
Eccles, Amy http://orcid.org/0000-0003-0561-395X
Lewington, Valerie http://orcid.org/0000-0002-8521-5478
Mitjavila, Mercedes
Percovich, Juan Carlos http://orcid.org/0000-0002-9244-6872
Lequoy, Benoît
He, Beilei http://orcid.org/0000-0002-4115-0115
Folitar, Ilya http://orcid.org/0000-0002-1399-0504
Ramage, John http://orcid.org/0000-0003-4824-6600
Funding for this research was provided by:
Advanced Accelerator Applications (AAA), a Novartis Company
Article History
Received: 22 October 2021
Accepted: 20 March 2022
First Online: 7 April 2022
Declarations
:
: The protocol of this retrospective study was reviewed by the Independent Ethics Committee or Institutional Review Board for each centre according to local regulations. While this was a non-interventional study that falls outside of the direct remit of the EU Clinical Trials Directive and therefore the ICH Guideline for Good Clinical Practice (ICH-GCP) does not strictly apply, the study was run according to the principles of the ICH-GCP where appropriate. The study was in accordance with the 1964 Helsinki Declaration and all its amendments up until the 64th World Medical Association (WMA) General Assembly (Fortaleza, Brazil, October 2013), the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP; ExternalRef removed) and International Society for Pharmacoepidemiology (ISPE) ExternalRef removed), the requirements of the General Data Protection Regulation (GDPR; ExternalRef removed) and all applicable laws and regulations.
: All study participants (or next of kin in the case of deceased patients, where required according to local regulations) provided written voluntary informed consent to participate in the study.
: The authors affirm that the participants of this study provided consent for publication of their data.
: The NETTER-R study was funded by Advanced Accelerator Applications (AAA), a Novartis Company. Dominique Clement has no relevant financial or non-financial interests to disclose. Frédéric Courbon has received honoraria from AAA; operated in an advisory role for AAA, Bayer, Vect-Horus and Ipsen; has received compensation to participate in a speakers’ bureau for AAA, Bayer, Global Health Education Consortium (GHEC) and Ipsen; and has received reimbursement from AAA, Bayer, GHEC and Ipsen for travel and accommodation expenses. Lawrence Dierickx has received reimbursement from AAA and Curium for travel and accommodation expenses. Lawrence Dierickx has uncompensated relationships with Novartis and Ipsen. Amy Eccles has received research funding from AAA. Ilya Folitar and Beilei He are employed by Novartis, own stocks in Novartis and have received reimbursement from Novartis for travel and accommodation expenses. Benoît Lequoy is employed by Novartis and owns stocks in Novartis. Valerie Lewington has been paid honoraria by AAA, Ipsen and Bayer; operated in an advisory role for AAA, Ipsen, Bayer and Nordic Nanovector; received compensation to participate in a speakers’ bureau for AAA, Ipsen and Bayer; and received research funding from AAA. Mercedes Mitjavila held an advisory role for AAA and Sirtex and received reimbursement from AAA and Curium for travel and accommodation expenses. Shaunak Navalkissoor has received compensation for a role in an advisory board of AAA. Juan Carlos Percovich operates in an advisory role for AAA and has received compensation to participate in a speakers’ bureau for AAA. John Ramage has received compensation for a role in advisory boards of Novartis, Ipsen and AAA, as well as for participating in speakers’ bureaus for Novartis, Ipsen and AAA; has received research funding from Novartis, Ipsen and AAA; and has received reimbursement from AAA and Ipsen for travel and accommodation expenses. Rajaventhan Srirajaskanthan has been paid honoraria by AAA and Novartis; has operated in an advisory role for AAA, Novartis and Ipsen; and has received research funding from Ipsen.
: Data were collected either by an external researcher or a member of the patient’s care team, as required according to local regulations. Prespecified information was collected in the study-specific electronic case report forms.
: United Kingdom• Common Law Duty of Confidentiality ExternalRef removed• NHS Code of Practice ExternalRef removed• UK Data Protection Act, 1998 ExternalRef removed• GDPR ExternalRef removedFrance• Research involving human subjects: Law n°2012-300 of 5th March 2012, Ordinance n° 2016-800 of 16th June 2016, French Public Health Code ExternalRef removed• Data protection ExternalRef removed<u>, </u>ExternalRef removed• GDPR ExternalRef removedSpain• 121/000013 Proyecto de Ley Orgánica de Protección de Datos de Carácter Personal (came into force on 25th May 2018) ExternalRef removed• Local regulation for conduct post-authorisation studies• Orden SAS/3470/2009, 16th December 2009 ExternalRef removed