The following studies are eligible for data sharing:
- As of January 1, 2014, 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. Approval must have been granted by both agencies, unless approval is only sought in either the EU or US.
- Prior to 2014, Phase 2 and Phase 3 studies approved in the EU and US, and all phase 4 studies, research proposals 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 clinical studies should be for the approved indication and must have already received a decision regarding journal publication and if accepted for journal publication, have already been published in a journal. If the study is not accepted for journal publication, or if Novartis chooses not to submit it for journal publication, then access to the anonymized study data will be granted.
- Phase 1 studies are excluded.
- Data access may be precluded for studies in which clinical data were collected subject to legal, contractual or consent provisions that prohibit transfer to third parties.
- 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 are studies listed on CSDR?
- After the medicine and indication have received EU and US regulatory approval before, on or after Jan 2014 and after the manuscript describing the trial results has been accepted for publication or published and no later than 18 months after the Study Completion Date.
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.
- 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. The Independent Review Panel is coordinated by the Welcome-Trust.
Datasets and documents provided
Where available, the anonymized patient level data and the following information is provided for each clinical study:
Anonymized raw dataset. This is the dataset
collected for each patient in the clinical trial.
Anonymized 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.