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Ionis

About	At Ionis, our efforts begin and end with the patient in mind; and we strive to understand their journey and meet their needs. Science is built upon a foundation of trust and integrity. We conduct research and the pursuit of new and novel therapeutics with the highest degree of integrity. Participants of clinical research put their trust in us, and they play a vital role in the advancement of science. For that reason, we must always appropriately protect the health, safety, and privacy of all clinical research participants. As members of the scientific community, we respect and adhere to applicable laws, regulations, and industry standards regarding ethical conduct in research. We share the findings of our research in a transparent, ethical, and accurate manner, regardless of the outcome, to further science and move closer to improving the lives of patients.
How we share on the Vivli Platform	Available studies are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data request form to request Ionis’ data package(s). If approved, requestors will need to sign a Data Use Agreement, after which anonymized data and documents may be shared in a secure research environment.
Studies Listed for Sharing	Ionis-sponsored phase II-IV interventional clinical trials conducted in patients for products and indications submitted and approved in both the United States and the European Union after January 1, 2024. Data will be provided to the researcher pending approval of a research proposal and a Data Use Agreement signed by the lead researcher and institution.
Exceptions	Studies where data sharing is prohibited by the consent, legal, regulatory, or contractual constraints on data sharing. Studies where the data requested is not appropriate for the research proposal and/or does not contain the data necessary to answer the scientific question proposed by the research. Studies where there is a risk of subjects being re-identified (for example, single center studies, small sample size of patients, rare indications with a small patient population and/or data types that lack anonymization standards). Studies where the data or documents are not in English, not in a format that enable sharing. Studies where a significant proportion of subjects must be removed due to national regulations. Studies that are ongoing, and/or do not have results posted. Studies related to a medicine that is being investigated in late-stage studies for an additional indication. As part of responsible data sharing, Ionis reserves the right to decline requests for data where proposed research will involve Artificial Intelligence (AI) solutions. The ethical standards and obligations around using individual patient data to develop AI techniques are in early stages of development across our industry as AI regulations and public perception are still forming. At this point in time Ionis cannot maintain adequate governance and oversight for AI solutions. Ionis does not generally share imaging data (e.g. DICOM files of images from x-rays, ultrasounds, MRI scans, etc.) and will only share genomic data with explicit consent.
When Studies are Listed	Ionis will routinely update the list of studies available.
Additional Conditions for Access	Access will be declined if: There is a potential conflict of interest, or an actual or potential competitive risk; The data requested is unavailable, not collected, or is not appropriate for the research proposal; The research proposal’s aim is considered commercial or litigious; The research proposal lacks clear scientific merit; or The research team lacks a biostatistician.
What information will be provided	We may share any or all of the following types of clinical data upon request and review: anonymized patient data, aggregated clinical data, other types of data, and/or de-identified Clinical Study Reports (CSR).
Questions or enquiries	Researchers can enquire about the availability of data from Ionis clinical studies that are not listed on the site before they submit a data request. Please use the Vivli Enquiry form.
Review Criteria for Data Requests	Ionis will complete due diligence in reviewing each request. Due diligence includes, but is not limited to, reviewing the research proposal, publication plan, applicable global laws and regulations, legal basis for sharing, data availability, business activities, and legal contracts. In general, the proposed research should at least meet the following criteria: The research objective can be met with the collected study data; The Informed Consents do not prohibit the proposed research; The data is not subject to legal, regulatory or contractual limitations; There are no competing publication plans; Study data and documents are in English; The proposal does not have potential to produce information that will enable identification of individual research participants; There are no practical constraints to providing the data (for example, issues related to the format of the databases or excessive operational costs preparing the data); The scientific rationale and relevance of the proposed research demonstrates a reasonable likelihood to improve medical science or patient care; The proposed research plan (design, methods and analysis) is reasonably likely to meet the scientific objectives; The plain English summary of the proposed research is clear with sufficient detail to be understood by a non-specialist; There are no real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research and proposals to manage these conflicts of interest; and The qualifications and experience of the research team to conduct the proposed research are appropriate.
Data Request Review Process	Data requests are initially assessed by Ionis to establish if the data can be shared based on established review criteria. The request and research proposal are then reviewed by the Independent Review Panel. In certain circumstances, access to data may be declined by Ionis, for example, where there is a potential conflict of interest or an actual or potential competitive risk.
Access to study documents without participant-level data	Access to the Clinical Protocol and Clinical Study Report may be provided without participant-level data, upon approval of the research proposal and execution of a Data Use Agreement.
Anonymization Standards	Ionis uses qualitative and quantitative risk management practices to create anonymized datasets and clinical study documents. We seek to prioritize the important data elements to deliver a data set to support an approved research project, balancing risk and utility for researchers. Ionis processes for anonymizing data are updated as knowledge, tools and best practices continue to evolve in order to achieve appropriate de-identification of clinical data. The data protection procedures performed prior to data sharing may include the following: Patient identifiers (subject number): Replaced by a new patient ID. Further unique identifiers: Removed (e.g. kit number) or scrambled (e.g. sample IDs). Site ID: Removed. Date of birth: Removed. Age: Kept, with Age >89 aggregated into a new variable. Country: Aggregated to continent level. Dates related to study subject: Date shifted by random shift factor. Same factor used for all dates of a patient, however different factors used for different patients. (NOTE: in some studies dates are replaced by a relative study day) Comments, free text, variables containing personally identifiable information (PII), e.g. names, initials: Removed. Some studies may require alternative data transformation procedures based upon dataset properties and re-identification risks.
Clinical Study Register or Website	https://clinicaltrials.gov/

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