Silvertown, Joshua D.
Lisle, Connie
Semenuk, Laura
Knapp, Colleen
Jaynes, Jillann
Berg, Doreen
Kaul, Nabodita
Lachapelle, Josianne
Richardson, Leslie
Speevak, Marsha
Sarras, Haya
Berman, David M.
Carter, Ronald
Feilotter, Harriet
Feltis, Timothy
Funding for this research was provided by:
Bayer Canada
Article History
Accepted: 4 September 2022
First Online: 4 October 2022
Declarations
:
: This research was funded by Bayer Inc.
: Harriet Feilotter received funding from Bayer Inc. to support implementation of the <i>Fast</i>TRK program and received honoraria from Bayer Inc. for speaking engagements. David Berman received compensation as a member of the Scientific Advisory Board for Acrivon Therapeutics. Marsha Speevak is employed as a consultant for LifeLabs. Joshua D. Silvertown and Haya Sarras are employed by Bayer Inc. Connie Lisle and Doreen Berg were previously employed by LifeLabs. Nabodita Kaul, Josianne Lachappelle, Leslie Richardson, Ronald Carter, and Timothy Feltis are currently employed by LifeLabs. Laura Semenuk, Colleen Knapp, Jillan Jaynes, David Berman, and Harriet Feilotter are currently employed by Kingston Health Sciences Centre.
: This study was conducted in accordance with the Helsinki Declaration of 1975 and with the approval of Veritas IRB Inc.
: Written informed consent was obtained from all subjects involved in the study.
: Not applicable.
: 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 scope, time point and process of data access. As such, Bayer commits to sharing, upon request from qualified scientific and medical researchers, anonymized 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 scientific review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.
: Not applicable.