Sharing Clinical Data
Orion is committed to transparency and external sharing of clinical trial data for the products approved in Europe and/or the United States to promote scientific and medical advancement. Orion complies with all applicable regulatory requirements regarding clinical trial disclosure by posting results directly to public clinical trial registries and registering all Orion-sponsored clinical trials and interventional trials conducted in patient (Phases 1-4). Requests for other clinical trial data are assessed on a case-by-case basis.
Orion respects patients’ informed consent, protects confidential patient information and Orion specific sensitive information in order to ensure patient privacy and the protection of proprietary information and therefore Orion will not share data in the following circumstances:
- when we believe that there is a reasonable likelihood that the individual could be re-identified, for example, clinical trials of rare diseases, omics data, single-center clinical trials, or clinical trials with a very small number of subjects
- where the Orion determines there is a reasonable likelihood that sharing data could otherwise violate privacy rights of individuals;
- if clinical data were collected subject to legal, contractual or consent provisions that prohibit or limit transfer to third parties;
- when phase IV clinical trials were conducted for non-registration purposes or other local affiliate trials;
- when informed consent specifically does not allow us to share data with a third parties
Data sharing request
Study and patient-level data sharing is based on a scientific review of the request.
Each request will be reviewed and evaluated by Orion based on:
- data requested
- rationale for the proposed research
- statistical analysis plan
- publication and posting plan
- qualifications and experience of requestor or intended researcher(s) and any potential conflicts of interests
- source of any research funding
Researchers are responsible for gaining any other approvals that are required for the research (for example, from Ethics Committees, Institutional Review Boards, relevant research institutions or funding bodies).
Access to data
If Orion agrees to the release of clinical trial data for research purposes, the requestor will be required to sign a Data Sharing Agreement prior to the release of any data. Orion will then provide access to the agreed anonymized data sets and redacted study documents such as the clinical study report synopsis, protocol and statistical analysis plan for the period as defined in the Data Sharing Agreement.