Rouyer, Magali
,
Oudard, Stéphane
Joly, Florence
Fizazi, Karim
Tubach, Florence
Jove, Jérémy
Lacueille, Clémentine
Lamarque, Stéphanie
Guiard, Estelle
Balestra, Aurélie
Droz-Perroteau, Cécile
Fourrier-Reglat, Annie
Moore, Nicholas http://orcid.org/0000-0003-1212-2817
Funding for this research was provided by:
Sanofi-Aventis France
Sanofi-aventis France
Sanofi-Aventis France
Sanofi-Aventis France. No grant number
Article History
Received: 28 May 2019
Revised: 24 September 2019
Accepted: 10 October 2019
First Online: 13 November 2019
Competing interests
: N.M. has received fees from Sanofi-Aventis for training in pharmacoepidemiology, independent from and before this study. He has received training or consulting fees from other pharmaceutical companies not involved in this study or in the treatment of prostate cancer. A.F.R. reports no conflicting interests. Bordeaux PharmacoEpi has several dozen ongoing studies financed by pharmaceutical companies outside the scope of this study. The salaries of Bordeaux PharmacoEpi employees (M.R., J.J., C.L., S.L., E.G., A.B., Cd.P.) are derived in part from the funding of this study, but they have no direct conflict of interest. S.O.: declares honoraria from Sanofi, Astellas, Janssen, Bayer. F.J.: declares scientific Board, consulting or lecture during symposium: Pfizer, Sanofi, Novartis, Bayer, Ipsen, Roche, Astra Zeneca, Tesaro, Astellas, Janssen, BMS, MSD; travelling: Tesaro, Janssen, Astra-Zeneca, BMS, Roche. K.F.: declares participation to advisory boards/honorarium for Astellas, AAA, Bayer, Clovis, Curevac, Incyte, Janssen, MSD, Orion, Sanofi. F.T. is head of the Centre de Pharmacoépidémiologie (Cephepi) of the Assistance Publique – Hôpitaux de Paris and of the Clinical Research Unit of Pitié-Salpêtrière hospital. Both these structures have received research funding, grants and fees for consultant activities from a large number of pharmaceutical companies, that have contributed indiscriminately to the salaries of its employees. She did not receive any personal remuneration from these companies.
: This study was evaluated by the regional committee for the protection of patients in clinical research (Sud-Ouest Outre-Mer III) on 18 May 2015, waiving individual patient consent for this non-interventional study. It was approved by the consultative committee on scientific research (CCTIRS) on May 7, 2015 (#CCTIRS15.583), and by the national data-protection committee (CNIL) on December 24, 2015 (# DR-2015-573). The study was performed according to the declaration of Helsinki in its latest version.
: The study was funded by Sanofi-Aventis, the company that markets cabazitaxel. The funder had no impact on the final protocol, which was approved by the French regulatory authorities, on the study conduct, on data analysis or the content of the present paper, though it was given the opportunity to comment, according to the ENCEPP Code of conduct.
: Not applicable.
: The data of this study are available, as per the ENCEPP code of conduct available at ExternalRef removed, upon providing the reasons for the request and the proposed study protocol.