Our Commitment to Sharing Data and Information
We provide access to anonymized, patient-level and study-level clinical trial data (analysis data sets) and other information (such as protocols and clinical study reports) from AbbVie sponsored Phase II-IV global interventional clinical studies in patients completed as of May 2004 for products and indications approved in either the United States or the European Union, as long as they are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Requests for other clinical trial data are assessed on a case-by-case basis.
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 Sharing Agreement (DSA). See the process outlined below for additional information.
Clinical trial data cannot be shared if:
- it can not be readily anonymized
- there is a reasonable likelihood that a patient could be re-identified (for example, clinical trials with a very small number of patients)
- the data is subject to legal, contractual or consent provisions that prevent further sharing of data
- there are practical constraints to providing the data (for example, issues related to the format of the databases)
How the Process Works
We provide researchers access to our data and information via a multi-step process.
How to Submit a Research Proposal
Researchers may submit requests for access to data and information from clinical trials in patients for medicines and indications approved in the United States and the European Union, for the purposes of conducting research in the interest of furthering the public health. To submit a request, the researcher must acknowledge our Access to Data and Information Privacy Agreement and submit the completed Access to Data and Information Research Proposal Form (Note: For Chrome users, right-click to download), including attachments, to firstname.lastname@example.org.
Researchers may identify AbbVie studies that may be related to their research proposal by searching public registries such as www.clinicaltrials.gov and literature databases such as Medline.
Researchers can expect to receive an acknowledgement that AbbVie has received their request.
Review of Research Proposal
All requests from researchers for access to AbbVie data and information will be managed by AbbVie, which may either grant or deny a request after reviewing the requestor’s proposal. 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. We will assist with submitting access to data and information requests that can be granted, consistent with the foregoing principles.
In cases where we reject a particular request 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 Research 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, and following receipt of a signed Data Sharing Agreement, anonymization of the requested data will occur and then we will grant access.
The signed Data Sharing Agreement will include the requestor’s agreement not to (1) transfer shared data or information to parties not identified in the research proposal, (2) use the data beyond purposes contained in the research proposal and (3) seek to re-identify research participants. Requestors shall also agree to share results with AbbVie, pursue publication of results and, if these results have implications for public health, share results with regulatory authorities prior to any publication. We encourage researchers to provide the Data Sharing Agreement template to relevant legal staff at their institution so it can be signed quickly following approval of the research proposal.
How Data is Provided on Our Website
Access to data needed for research is provided on a password-protected website (SAS Portal). This website 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. There are controls in place to prevent researchers from downloading any patient-level data provided to their computer, as we strive to protect research participants’ privacy and confidentiality, and also help ensure the data are used for the agreed research purpose.
Statistical Software that is Provided
Commonly used statistical software “R” and “SAS” are provided on the website so researchers can conduct their analyses.
Disclosure of Research Results
The Data Sharing Agreement requires that, after the researcher has completed the research per the approved study proposal and analysis plan, the researcher will share results with AbbVie and pursue publication of results.