Study sponsor: Novartis
||Novartis is committed to sharing clinical trial data with external researchers and
has been doing so voluntarily for several years through its own web portal. The
following studies are eligible for data sharing:
1) Phase 2 and Phase 3 studies that are part of the submission package for a new
medicine or new indication for regulatory approval of a previously approved medicine
in the EU and US as of January 1, 2014. Approval must have been granted by both
agencies, unless approval is only sought in either the EU or US.
2) For Phase 2 and Phase 3 studies approved in the EU and US prior to 2014, research
proposals requesting data from Novartis will be reviewed on an individual basis
and data provided if materially possible (it may not be possible to provide data
from studies that are more than ten years old).
The requested clinical studies should be for the approved indication and must have
already received a decision regarding publication and if accepted for publication,
have already been published. If the study is not accepted for publication, or if
Novartis chooses not to submit it for publication, access to study data will be
||Phase 1 studies are excluded as are Phase 4 clinical studies conducted for purposes
other than registration, and local affiliate studies.
Studies in which clinical data were collected subject to legal, contractual or consent
provisions that prohibit transfer to third parties, data access may be precluded.
Novartis will not share data when there is a reasonable likelihood that individual
patients could be re-identified, for example, in clinical studies of very rare diseases,
single center studies or studies with a very small number of patients.
Novartis will not share case narratives, documentation for adjudication, imaging data (e.g. x-rays, MRI scans, etc.), genetic data and exploratory biomarker data.
It is Novartis Policy not to share data from interim trial results, even if a Health Authority approval has been granted based only on interim trial data. Novartis will share data when the trial CSR is completed and the results published.
Studies supporting device registration or generic registration are not currently
part of this data sharing commitment.
|When studies are listed
||After the medicine and indication have received EU and US regulatory approval on
or after Jan 2014 and after the manuscript describing the trial results has been
accepted for publication.
|Additional conditions for data access
||Participants in Novartis-sponsored trials gave their consent for the use of their
data in the context of a particular trial. The external research request must therefore
intend to study the medicine or disease that was intended in the original study.
For future Novartis studies patients will be asked to give permission for broader
research beyond the original study intent so other research may be possible with
data from these studies.
Access to data is determined by the Independent Review Panel based on the scientific
merit of the research proposal. 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.
|Datasets and documents provided
||Where available, the following anonymized patient level data and information is
provided for each clinical study.
Raw dataset. This is the dataset collected for each patient in the clinical
Analysis-ready dataset. This is the dataset Novartis used for analysis.
Protocol with any amendments. This describes the objectives, design, methodology,
statistical considerations, and organization of a clinical trial. The protocol is
part of the appendices of the clinical study report.
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 and data displays (tables, listings and figures) Novartis used
for the trial.
Dataset specifications. This is the meta-data which describe the datasets,
e.g., variable labels and 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
US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices
which include patient level data are not included as these data are provided in
the anonymized datasets. To protect research participants’ privacy and confidentiality,
personally identifiable information will be redacted.
Redactions to this document will also be made to protect Novartis and study personnel
personal data, and to protect Novartis’s commercially confidential information,
including intellectual property rights.
||Researchers may enquire about the availability of data from Novartis clinical studies
that are not listed on the site before they submit a research proposal.
|Access to study documents without patient-level data
||Access to clinical study documents is provided upon receiving Independent Review Panel approval of a research proposal.
|Review criteria for enquiries
||Responses to enquiries will be given for listed and unlisted studies. Please refer
to the above sections “Studies listed” and “Exceptions.”
|Clinical study register