Clinical Data Sharing Governance

The responsible sharing of clinical trial data is part of Helsinn’s commitment to supporting efficient clinical research that generates new learnings and brings benefits to patients. Helsinn welcomes qualified researchers’ requests for secondary research based on data from Helsinn-sponsored clinical trials whose primary results have been published in peer-reviewed journals, provided that the drug subject to the investigation has received, for the indication used in the trial, a marketing approval from regulatory authorities in the USA, the EU, and/or Japan. Access to clinical data may be provided in response to scientifically valid research proposals and is contingent upon both data request approval by a dedicated review committee and the execution of a data-sharing agreement with the researcher. Data requestors are required to submit a research proposal to document their qualifications and the legitimacy of the research question. Research proposals should include the following:

• a description of the data being requested, including the hypothesis to be tested
• a clear and robust study synopsis
• a rationale for the proposed research
• a well-documented and rigorous statistical analysis plan
• qualifications and experience of the proposed research team
• a description of any potential conflicts of interest, including potential competitive use of the data
• the source of any research funding
• an adequate publication and posting plan

The sharing of data and other clinical trial information shall be consistent with the principle of safeguarding patient privacy and will not be accepted if there is a reasonable likelihood that individual patients could be identified or where there are limitations or restrictions due to privacy rights of individuals in accordance with applicable privacy laws. Patients’ informed consent relating to their participation in the clinical trial will always be respected. Any patient-level data that is shared will be anonymized to protect patients’ personal data. In some cases, clinical data may have been collected subject to legal, contractual or consent provisions that prohibit transfer to third parties. Such restrictions may preclude granting access to clinical trial data. Where legal restrictions prevent Helsinn from sharing certain kinds of data, Helsinn may work with qualified requestors to provide summary information where possible.

• Data access will not be granted if the research proposal competes with Helsinn publication plan
• Qualified researchers who are provided access to Helsinn data must agree: to sign a data-sharing agreement with Helsinn; to publish the results of their analysis in a peer-reviewed journal or scientific meeting; not transfer the shared data or information to parties not identified in the research proposal, use the data for purposes not contained in the research proposal or seek to identify research participants