|About||Lilly unites caring with discovery to create medicines that make life better for people around the world.|
|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 Lilly data package(s).|
|Studies listed for sharing||Lilly will list Lilly-sponsored interventional clinical studies from approved medicines and indications in the United States (US) and European Union (EU) in the following categories
Additional studies outside of this scope may be proactively listed by Lilly.
|Exceptions||Interventional clinical studies of rare diseases or single site studies may be excluded from proactive listing on this site. This is because anonymisation of these data is more difficult to achieve. For these studies Lilly will assess the feasibility of anonymisation as part of the review of enquiries described below.
Interventional clinical studies where Lilly is the sponsor but does not have the legal authority because the medicine has been out-licensed to another company or the data are the property of an academic organization.
|When Studies are available for sharing||Studies are listed 6 months after the studied medicine and indication have been approved by regulators in the US and EU and after the primary manuscript describing the results has been accepted for publication, whichever is later.|
|Additional Conditions for Access||In exceptional circumstances, access to data may be declined by the sponsor, for example, where there is a potential conflict of interest or an actual or potential competitive risk.|
|What information will be provided|| When available, the following anonymised patient level data and information is provided for each clinical study:
🗹 Raw dataset. This is the data collected for each patient in the clinical study. PK data is not routinely provided.
🗹 Analysis-ready dataset. This is the dataset used for Lilly’s analysis. PK data is not routinely provided.
🗹 Protocols with any amendments or addenda. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.
🗹 Annotated case report form. This is a blank case report form with descriptions of the data collected, metadata and how they are described in the dataset. If an annotated case report form is unavailable, a blank case report form may be provided.
🗹 Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) Lilly used for the study.
🗹 Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, formats.
🗹 Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the US FDA and the European Medicines Agency (EMA). Appendices which include patient level data are not included as these data are provided in the datasets Lilly provides. To protect research participants’ privacy and confidentiality, case narratives are not routinely included. They may be provided where they are needed for a specific research proposal, provided research participants’ privacy can be protected.
|Questions or enquiries||Researchers can enquire about the availability of data from Lilly clinical studies that are not listed on the site before they submit a research proposal.|
|Review Criteria for Data Requests||
The qualifications and experience of the research team to conduct the proposed research (a statistician with a degree in statistics or a related discipline should be part of the research team).
|Data Request Review Process||Data requests are initially reviewed by Vivli and Lilly for completeness and other parameters (relating to scope, system-compatibility, and meeting sponsor policies) and are then reviewed by a fully independent review panel in a process that is managed by the Wellcome Trust.. The review panel will consider the following:
|Access to study documents without participant-level data||Researchers can enquire about access to clinical study documents only (without patient-level data, such as the Clinical Study Report) by completing the online enquiry form.|
|Anonymization Standards||Anonymization Standards|
|Clinical Study Register or Website||Lilly currently registers all its local and global interventional clinical studies on ClinicalTrials.gov|