|About||Bayer – Science for a better health
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.
|How we share on the Vivli Platform||Available studies are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data request form to request Bayer data package(s). Data and documents will be shared under agreements that further protect against participant reidentification and data are provided in a secure research environment further protecting participant privacy.|
|Studies Listed for Sharing||Clinical trials in patients sponsored by Bayer that have been submitted to the US and EU regulatory agencies as part of the request for marketing authorization for new medicines or indications for products that have been approved by both of the agencies on or after Jan 01, 2014.
For products that have not received market approval in either US or EU before Jan 01, 2014, data will be shared if they have been approved on or after Jan 01, 2014 by only one of the agencies, provided clinical trials are not part of an ongoing review or are going to be part of a planned submission to a highly regulated regulatory authority such as EMA or FDA.
|Exceptions||Bayer will not share data when we believe that there is a reasonable likelihood that the individual could be re-identified, for example, clinical studies of rare diseases, single-center clinical studies, or clinical studies with a very small number of subjects.
Bayer may not be able to share data in case of substantial practical constraints to provide technical data access. For example, there may be issues related to the size of databases from genetic studies.
Where clinical data were collected subject to legal, contractual or consent provisions that prohibit transfer to third parties, or in case of substantial conflicts of interest, data access under this policy may be precluded.
|When Studies are available for sharing||Studies are considered for listing as available after regulatory approval. In case of planned scientific publications, studies will be listed once the primary manuscript describing the results has been accepted for publication.|
|Additional Conditions for Access||When patients agreed to take part in Bayer clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease Bayer was researching. Further research must therefore study the medicine or disease that was researched in the original studies. For studies Bayer plans from May 01 2014, patients will be asked to give permission to anonymization of their data so further research can be conducted with data from these studies.
For partnered compounds data access will be provided if the development partner agrees to data access and to related data sharing agreements with the requesting third party. Data Access can be provided when it has been technically implemented (planned by Dec 2014).
In exceptional circumstances, access to data may be declined by the sponsor, for example, where there is a potential conflict of interest or an actual or potential competitive risk.
|What information will be provided||Where available, the following anonymised patient level data and information is provided for each clinical study.
Raw dataset. This is the dataset collected for each patient in the clinical study.
Analysis-ready dataset. This is the dataset used for Bayer’s analysis.
Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study.
Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.
Reporting and analysis plan. This describes methods of analysis, procedures for data handling Bayer used for the study.
Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.
Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices that contain no patient relevant data (e.g. audit certificates or manuals from providers of various diagnostic services) as well as individual patient level data (e.g. narratives) are not included. The data from narratives will of course be contained – in aggregated fashion – in the datasets provided by Bayer.
Documents will be redacted to protect personal data of study participants, study personnel, and Bayer employees, and to protect Bayer’s commercially confidential information, including intellectual property rights.
|Questions or enquiries||Responses to enquiries will be provided for studies listed. For studies not listed please refer to Bayer’s Clinical Trials Explorer: Welcome to Bayer Clinical Trials|
|Review Criteria for Data Requests||Bayer will complete due diligence in reviewing each data request. Due diligence includes, but is not limited to reviewing the research proposal, publication plan, applicable global laws and regulations, legal basis for sharing, data availability, business activities, and legal contracts.|
|Data Request Review Process||Data requests are assessed first by Bayer to establish if the data can be shared based on established review criteria. The request and research proposal are then reviewed by the Independent Review Panel.|
|Access to study documents without participant-level data||Access to study documents without patient-level data will be provided for studies listed. For studies not listed please refer to Bayer’s Clinical Trials Explorer: Welcome to Bayer Clinical Trials|
|Anonymization Standards||Bayer Anonymization Standards|
|Clinical Study Register or Website||Bayer’s Clinical Trials Explorer: Welcome to Bayer Clinical Trials|