Teva Branded Pharmaceutical Products R&D, Inc. (Teva) is committed to sharing both patient-level and study-level clinical trial data from interventional clinical trials using Teva Specialty Branded products approved in the United States (US) and European Union (EU) after January 2014, to conduct legitimate research.
Exceptions include clinical trials of generic and biosimilar products, Investigator Sponsored Studies, clinical trials for which Teva is not the sponsor or responsible party, and non-interventional studies.
Clinical trials will be listed when the applicability criteria have been met including product status criteria and no exclusion criteria or exceptions apply.
Teva evaluates the scientific merit of the research proposal and analysis plan, feasibility of the request, researcher and statistician qualifications, product status, potential conflicts of interest, informed consent language allowances or restrictions, and the publication plan when determining whether to share data.
Researchers must enter into a Data Sharing Agreement with Teva before the requested information (e.g., de-identified clinical data, redacted documents) may be provided. The Data Sharing Agreement commits individual researchers to using the requested data only for the stated research (i.e., non-commercial) purposes and disallows disclosure of the data to third parties. This practice is consistent with data privacy requirements. Researchers must commit to transparency in the publication of their work.
Teva will grant access to de-identified patient-level data, study-level data, redacted protocols, and redacted statistical analysis plans if a formal request is approved and the data sharing agreement is signed. Teva will consider each request including the scientific merit of the proposed research, the protection of clinical trial participant information, the informed consent language of the relevant trials, the publication plan for results, and the protection of commercially confidential information before deciding whether to share clinical trial data.
When requested and available, the following de-identified patient level data and redacted documents may be provided.
Researchers may request clarification about clinical trial data before submitting a research proposal.
Teva will assess if there are co-development agreements or licensing agreements that would exclude data sharing.
Teva will evaluate the risk of patient re-identification for all data sharing requests. If the risk of re-identification is too high due to a small sample size, rare disease trial, single-center/country studies or other privacy risk factors, we may not be able to share clinical trial data.
Teva will consider any informed consent language allowances or restrictions.
Teva considers any practical constraints to providing access to the data. For example, we consider if the data are still available and if we have the resources to retrieve the data and to de-identify personal information as well as to redact confidential information.
We consider the status of the product when evaluating data sharing requests.
Teva may not be able to share data if privacy risks or other exclusions are identified.
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