Ethical approval and consent to participate
A database was created in accordance with the reference methodology MR004 of the National Commission of Liberties and Informatics (n°2206749, 13/09/2018). A non-opposition form was sent to each living patient included in the study. As per French regulations, no additional ethical committee review was required.
Decree No. 2016-1537 of November 16, 2016 relating to research involving the human person. This decree is taken for the application of the modified law n° 2012-300 of March 12, 2012 relating to research involving the human person known as “Loi Jardé”.
Non-interventional research (Category 3): This is research that does not involve any risk or constraint, does not modify the care of the participants and in which all the acts are performed and the products used in the usual way. They are also referred to as “observational research”. For example, they may relate to treatment compliance, monitoring of a drug after it has been marketed, the practices of one healthcare center compared to those of another, etc.
Category 3 searches also require receiving:
• an authorization from the Commission Nationale Informatique et Liberté (CNIL) or respecting a reference methodology (MR004) concerning the processing of the personal data of the persons involved.
• informing the ANSM of the opinion issued by the Committee for the Protection of Persons, without its authorization being required.
• the information of the people involved in the research and the collection of their non-objection to the use of the data collected.
The Jardé law considers that it is not a study on human beings but a study on medical records (and therefore that there is no need for an opinion from a committee for the protection of people) The CNIl reference methodology MR004 imposes patient information (non-objection form) with an exemption from information for deceased subjects (if the subject did not express his opposition to the use of its data for research).
No administrative permissions were required to access the raw data used in ourstudy.
The data used in this study were anonymised before its use.
Consent for publication
Availability of data and materials
All data are availlable by asking the corresponding author at [email protected]
C-GR reports honoraria as a speaker and/or in an advisory role from Takeda, Gilead, Ferring, and Tillots, unrelated to this work.
DB reports honoraria as a speaker and/or in an advisory role from Amgen, Accord Healthcare, Sanofi, Servier, Roche and Pierre Fabre, unrelated to this work.
MB reports honoraria as a speaker and/or in an advisory role from Astra-Zeneca, Amgen and Bayer, unrelated to this work.
VH reports honoraria as a speaker and/or in an advisory role from Merck KGaA and Amgen, unrelated to this work.
AL reports research funding from Roche, and honoraria as a speaker and/or in an advisory role from Amgen, and receiving lecture fees from Vifor Pharma, Bayer, Merck, Sanofi, and Ipsen, unrelated to this work.
FS reports honoraria as a speaker and/or in an advisory role from Gilead, and Astra-Zeneca, unrelated to this work.
OB reports honoraria as a speaker and/or in an advisory role from Merck KGaA, Roche Genentech, Bayer, MSD, Amgen, Sanofi, Servier, and Pierre Fabre, unrelated to this work.
All remaining authors have declared no conflicts of interest.
No external funding was received for this study or for the preparation of this manuscript.
The authors would like to thank Ms. Daniela Pellot of the SERRA at Reims Faculty of Medicine for assistance with English language editing.