Sponsor Specific Details: 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, and all phase 4 studies, 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 granted.

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.

Requests for clinical trial data from trials that completed after January 1, 2014 will be made available after the medicine and indication is approved by both the FDA and EMA (or is approved by one of these agencies if submitted to only one agency), or 18 months after trial completion, whichever is the latest. Requests for trial data from approved medicines before 2014 are reviewed on a case-by-case basis. Access to the data is granted upon review by an independent scientific review panel.

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.

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 trial.

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 clinical study documents is provided upon receiving Independent Review Panel approval of a research proposal.

Responses to enquiries will be given for listed and unlisted studies. Please refer to the above sections "Studies listed" and "Exceptions."

www.NovartisClinicalTrials.com