Boettcher, Michael
Loewen, Stephanie
Gerrits, Mireille
Becker, Corina
Funding for this research was provided by:
Bayer
Merck Sharp & Dohme Corp.
Article History
First Online: 8 October 2020
Declarations
:
: Michael Boettcher and Corina Becker are employees of Bayer AG and may own stock in the company. Stephanie Loewen is an employee of Chrestos Concept GmbH & Co. KG, and a paid consultant for Bayer Healthcare Pharmaceuticals. At the time of performing the studies Mireille Gerrits was an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
: Funding for this research was provided by Bayer AG, Berlin, Germany, and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the relevant IEC or IRB and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards, and the International Conference on Harmonisation guideline E6: Good Clinical Practice (GCP).
: Written informed consent was obtained from individuals in each study.
: All authors drafted the article and/or revised it critically for important intellectual content and provided final approval of the published version.
: Availability of the data underlying this publication will be determined according to Bayer’s commitment to the EFPIA/PhRMA “Principles for responsible clinical trial data sharing”. This pertains to scope, timepoint and 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 United States (US) and European Union (EU) as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 1, 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.