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.
We provide researchers access to our data and information via a
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
- analysis plan
- publication and posting
- 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).
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.
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 and 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.
Commonly used statistical software is provided on the platform so
researchers can conduct their analyses. More information about the
available software is on Vivli.
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.