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. |
Anonymization Standards | Ionis uses qualitative and quantitative risk management practices to create anonymized datasets and clinical study documents.
The data protection procedures performed prior to data sharing may include the following:
Some studies may require alternative data transformation procedures based upon dataset properties and re-identification risks. |
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 requests from qualified researchers will be considered once each of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; and (2) 18 months from conclusion of the study. 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 |
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:
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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:
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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. |
Clinical Study Register or Website | https://clinicaltrials.gov/ |