Zurth, Christian http://orcid.org/0000-0002-0881-846X
Nykänen, Pirjo
Wilkinson, Gary
Taavitsainen, Päivi
Vuorela, Annamari
Huang, Funan
Reschke, Susanne
Koskinen, Mikko
Clinical trials referenced in this document:
Documents that mention this clinical trial
Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment
https://doi.org/10.1007/s40262-021-01078-y
Documents that mention this clinical trial
Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment
https://doi.org/10.1007/s40262-021-01078-y
Documents that mention this clinical trial
Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment
https://doi.org/10.1007/s40262-021-01078-y
Funding for this research was provided by:
Bayer AG
Orion Corporation Orion Pharma
Article History
Accepted: 27 September 2021
First Online: 6 December 2021
Declarations
:
: Funding for this work was provided by Bayer AG and Orion Corporation Orion Pharma.
: Susanne Reschke reports employment by Bayer. Christian Zurth, Funan Huang, and Gary Wilkinson report employment by and stock ownership in Bayer. Pirjo Nykänen, Päivi Taavitsainen, and Annamari Vuorela report employment by Orion Pharma. Mikko Koskinen reports employment by and stock ownership in Orion Pharma. Medical writing support, including assisting authors with the development of the outline and initial draft and incorporation of comments, was provided by Francesca Kolbe, PhD, and Tamsin Williamson, and editorial support was provided by Annabel Ola, MSc, all of Scion (London, UK) supported by Bayer Healthcare Pharmaceuticals, Inc. (Whippany, NJ, USA). Medical writing support, including assisting authors with the development of the submission draft, was provided by Sara Black, ISMPP CMPP™, of OPEN Health Communications (London, UK), supported by Bayer.
: All studies were conducted in accordance with the International Council for Harmonization Good Clinical Practice, the principles of the Declaration of Helsinki, and all applicable national regulations. The study protocols were reviewed and approved by the following independent ethics committees: Wales Research Ethics Committee 2, Cardiff, UK (ARIADME Study); Ethik-Kommission der Ärztekammer Schleswig-Holstein, Bad Segeberg, Germany (Study 17721); and Landesamt für Gesundheit und Soziales Geschäftsstelle der Ethik-Kommission des Landes Berlin, Berlin, Germany (Study 17723).
: For all clinical studies described in the article, informed consent was obtained from the participants.
: All patients provided consent for publication of their pooled, anonymized data.
: Availability of the data underlying this publication will be determined later according to Bayer’s commitment to the EFPIA/PhRMA “Principles for responsible clinical trial data sharing”. This pertains to the scope, timepoint, and the process of data access. As such, Bayer commits to sharing, upon request from qualified scientific and medical researchers, patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the USA and European Union as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the European Union and US regulatory agencies on or after 1 January, 2014. Interested researchers can use ExternalRef removed to request access to anonymized patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the study sponsors section of the portal. Data access will be granted to anonymized patient-level data, protocols, and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.
: Not applicable.
: Participated in clinical study design: PT, PN, MK, AV, and CZ. Conducted experiments: PN, SR, PT, AV, and GW. Performed data analysis: FH, MK, PN, PT, and CZ. Wrote or contributed to the writing of the manuscript: FH, MK, PN, SR, PT, AV, GW, and CZ.