Clinical Trial Data Sharing

Actelion Pharmaceuticals Deutschland GmbH is committed to improving patient care by developing meaningful products that address unmet medical needs. As part of this commitment, Actelion has established a process to review requests from qualified external researchers for data from Actelion-sponsored clinical trials. As part of Actelion Pharmaceuticals Deutschland GmbH’ approach to sharing data in a responsible manner that includes protecting patient privacy, assurance of data security and integrity, and furthering scientific and medical innovation.

Scope

External researchers may submit requests for data generated from Actelion Pharmaceuticals Deutschland GmbH-sponsored clinical trials. Requests must be for data owned by Actelion Pharmaceuticals Deutschland GmbH from completed trials where the product/indication is approved in the US or EU. Researchers submitting a request must not have any actual or potential conflicts of interest.

Process

Submitting a request

• Qualified researchers may submit a data sharing request for consideration. Only complete requests including the research objectives, products/studies in scope, statistical analysis plan, and publication plan will be considered.
• To submit your request, please complete the Data Sharing Request Form. For any questions, please contact clinicaldatasharing@actelionpharmaceuticals.de.
• Additional Documents to be submitted along with request:
  • Conflict of Interest
  • Data Sharing Agreement

Review

• Each request will be considered by an internal Actelion committee. Requests will be reviewed based on factors including, but not limited to, Actelion’s ability to share the requested data, qualifications of the researcher, legitimacy of the research purpose and scientific merit.
• Actelion Pharmaceuticals Deutschland GmbH reserves the right to not approve requests for any reason.

Data Access

• Upon an approved request, a data sharing agreement must be fully executed prior to Actelion granting a researcher access to data.
• Following request approval and the execution of a data sharing agreement, the researcher will be granted a license to software where the de-identified data will be uploaded. The researcher is responsible for protecting the confidentiality of the data while conducting their research and will not transfer the shared data or information to parties not identified in the research proposals, use the data for purposes not included in the research proposal, or seek to de-identify research participants. Any attempt to breach the confidentiality obligations in the data sharing agreement or download the data will result in a revocation of the researcher’s license.

Publication

• The final step in the data sharing process is when the researcher publishes their research findings. Actelion reserves the right to review the manuscript/items for publication. However, Actelion cannot exercise editorial control over the publication.