Study sponsor: Bayer
||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 and indications:
- for products that have been approved by both of the agencies on or after Jan 01,
- for products that 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.
||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 listed
||Studies are considered for inclusion in the “Study list” (see section “Studies listed”)
after regulatory approval. In case of planned scientific publications, studies will
be listed once the primary manuscript describing the results has been accepted for
|Additional conditions for data 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
|Datasets and documents 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
Analysis-ready dataset. This is the dataset used for Bayer’s analysis.
Protocol 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
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
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.
||Responses to enquiries will be provided for studies listed. For studies not listed
please refer to Bayer's TrialFinder application
|Access to study documents without patient-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 TrialFinder application.
|Review criteria for enquiries
||Please see section above and refer to the sections “Studies listed” and “Exceptions”.
|Clinical study register