For Researchers

Data Sharing and Clinical Trial Conduct

Data Sharing with Qualified External Researchers

Teva is committed to sharing both patient-level and study-level clinical trial data, as well as protocols from clinical trials using Teva Specialty Branded products that were approved in the United States (US) and European Union (EU) as of January 2014, to aid in conducting legitimate research. Access will be granted to de-identified patient-level data, protocols, and statistical analysis plans if a formal request is approved by a review panel. Teva will consider the scientific merit of the proposed research, the protection of clinical trial participant information, the publication plan for trial results, and the protection of commercially confidential information before deciding whether to share clinical trial data.

Teva seeks to support researchers by providing data with the highest levels of clinical utility, while ensuring participant privacy obligations are met. Patient-level data will be de-identified and documents will be redacted to protect the privacy of trial participants and commercially confidential information. Teva follows guidelines for de-identification of patient-level data, which are derived from industry best practices provided by organizations such as PhUSE and TransCelerate.

Qualified researchers seeking to advance medical science or improve patient care may request access to Teva data by submitting a proposal form to [email protected] with all required supporting documentation.

Researchers requesting access to Teva data must enter into a Data Sharing Agreement with Teva before the requested information (e.g., de-identified clinical data, documents) is 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 in line with data privacy legislation. Researchers are also expected to commit to transparency in the publication of their work.

Compassionate Use Programs

Teva supports requests for participation in compassionate use programs (CUPs) that meet the criteria outlined in our policy. Compassionate use provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices for serious diseases or conditions that might not otherwise be available.

If you are a patient, Teva’s current CUPs offer a mechanism for access to our investigational medicines, including drugs and biologics, outside of clinical trials when deemed appropriate, in the best interest of the patient, and consistent with Teva’s strategy. Please contact your healthcare provider to inquire about requesting compassionate use.

If you are healthcare provider and wish to submit an CUP request on behalf of a patient, please submit this form to [email protected]. Teva will respond within one business day to confirm receipt of the request and outline next steps.