Our Commitment to Sharing Data and Information
Qualified researchers engaged in rigorous, independent scientific research can request access to our clinical trial data. Access will be provided following receipt of a research proposal and Statistical Analysis Plan (SAP), review of the proposal and SAP and execution of a Data Use Agreement (DUA). All requests from qualified researchers for access to AbbVie clinical data and information will be managed by Vivli and AbbVie. To submit a request, visit Vivli.
How the Process Works
We provide researchers access to our data and information via a multi-step process.
Review of Research Proposal
Proposals received via Vivli are provided to AbbVie. Our company will ensure that the proposal has clearly defined research questions and scientific merit and that the researcher-directed analyses follow the research proposal.
In determining whether a specific request for access to data and clinical trial information shall be granted, AbbVie shall consider all relevant information, including:
- data requested
- hypothesis to be tested and the rationale for the proposed research
- 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
Interactions between our company and requestors of access to data and information are intended to be collaborative in nature.
In cases where a request is rejected based on scientific merit, the request, along with the record of our denial of the request, shall be forwarded to the Access to Clinical Research Information Board (ATCRIB) for a final decision, according to the ATCRIB charter. The ATCRIB is composed of scientists and/or health care professionals who are not AbbVie employees.
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
We anticipate being able to respond to the requestor within a reasonable period of time from submission of a complete research proposal. When the request is approved, Vivli will initiate a Data Use Agreement (DUA). Once the DUA is executed, the anonymized data will be uploaded on the Vivli platform for access by the requestor.
We encourage researchers to provide the DUA template to relevant legal staff at their institution so it can be signed quickly following approval of the research proposal.
How the Data Is Provided
Access to data needed for research is provided on a password-protected platform via Vivli. This platform allows researchers to conduct research on the site and to download their analyses. Access is provided for 12 months. Extensions are possible when justified and upon review and approval.
Researchers are invited to conduct their research in a private workspace. This workspace is not accessed by AbbVie or any other third party unless researchers provide permission. To protect research participants privacy & confidentiality and ensure the data is used for the agreed research purpose, controls are in place to prevent the download of anonymized data provided for access.
Statistical Software that Is Provided
Commonly used statistical software is provided on the platform so researchers can conduct their analyses. More information about the available software is on Vivli.
Disclosure of Research Results
After the researcher has completed the research per the approved study proposal and analysis plan, the researcher is expected to publicly share the results per the executed DUA.