Center for Global Research Data

Our Members

AbbVie

About Research and innovation are the cornerstones of our business. We advance leading-edge science through a dynamic and collaborative approach. This enables us to find better solutions for treating the world’s most challenging diseases. We focus on discovering, developing and delivering drugs in therapeutic areas where we have proven expertise—and can make an impact.  This includes Immunology, Oncology, Neuroscience, Virology, and General Medicine. 

Our Commitment to Data and Information Sharing 

There are important health benefits in making clinical trial data and information available to health care providers, researchers, patients and the general public. Thus, we have adopted national and international principles and standards regarding the sharing and publication of clinical trials data and information.

Studies Listed for Sharing  AbbVie studies that are available for data sharing are listed on Vivli.   We provide access to anonymized, patient-level and study-level clinical trial data 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 commercially available medicinal  products and indications that have received an initial marketing authorization in the following countries/regions, as long as they are not part of an ongoing or planned regulatory submission:

  • US and EU 
  • US or EU (when regulatory submissions in both regions are not planned). 
  • Other country (when US or EU regulatory submissions are not planned). 

Requests for other clinical trial data are assessed on a case-by-case basis, as defined in the Questions or enquiries section.

Exceptions Clinical trial data cannot be shared if: 

  • It cannot 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, and/or resources (costs) are considerable to retrieve data) 
  • Study documentation is not in English.

AbbVie does not generally share documentation used for adjudication, imaging data (e.g. x-rays, MRI scans, etc.), genetic data and exploratory biomarker data. 

When Studies are Available for sharing Once a product is approved for the given formulation in the given indication and the primary manuscript describing the results from the study has been accepted for publication, the study will be listed on Vivli.  The list of available studies will be updated on a semi-annual basis.
Additional Conditions for Access When patients agreed to take part in clinical studies they gave permission (through an informed consent) to use their data to study the medicine or disease under research.  Further research must therefore relate to the medicine or disease that was researched in the original studies. 

In exceptional circumstances, access to data may be declined, for example, where there is a potential conflict of interest or an actual or potential competitive risk.

What information will be provided Where available, the following anonymised patient level data and information is provided for each clinical study: 

🗹 Individual Patient Data – This is the dataset collected for each patient in the clinical study. 

🗹 Analysis-ready dataset – This is the dataset AbbVie used for analysis.  

🗹 Annotated case report files (CRFs) – This is a set of blank study CRFs that have been annotated with the dataset variable names.  This will be provided when available.   

🗹 Dataset specifications /Define file – This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.    

🗹 Statistical analysis plan – This describes methods of analysis and procedures for data handling that AbbVie used for the study report.  

🗹 Clinical protocol – This describes the objective(s), design, methodology, statistical considerations, and organization of a trial.     

All documents will be redacted/anonymized to protect personal data of study participants, study personnel, and AbbVie employees. 

Questions or enquiries

Researchers can enquire about the availability of data from AbbVie clinical studies that are not listed on the site by contacting accesstodata@abbvie.com. This includes requests for clinical trial data for unlicensed products and indications.  These requests will be considered on a case-by-case basis. AbbVie studies are registered on Clinicaltrials.gov and/or the EU Clinical Trials Register.  

Data Request Review Process Access to data is determined based on the scientific merit of the research proposal.  AbbVie utilizes an in-house review committee composed of senior leaders from diverse areas within AbbVie.   In cases where the internal committee rejects a request based on scientific merit, the request, along with the record of our denial of the request, will be forwarded to an external board, the Access to Clinical Research Information Board (ATCRIB), for a final binding decision, according to the ATCRIB charter.  The ATCRIB is composed of scientists and/or health care professionals who are not AbbVie employees.
Review Criteria for Data Requests 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. 
Access to study documents without participant-level data Access to the following documents may be provided without participant level data, upon approval of the research proposal and execution of the Data Use Agreement (DUA).     

Statistical analysis plan – This describes methods of analysis and procedures for data handling that AbbVie used for the study report.  

Clinical protocol – This describes the objective(s), design, methodology, statistical considerations, and organization of a trial.  The last version of an amended protocol will be provided.   

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 Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA). Appendices that contain no patient relevant data (e.g. audit certificates or manuals from providers of various diagnostic services) are not included.  To protect research participants’ privacy and confidentiality, case narratives are not routinely included.  The data from narratives – in aggregated fashion – are provided.  Appendices which include patient level data are not included as these data are provided in the datasets AbbVie provides.    

All documents will be redacted/anonymized to protect personal data of study participants, study personnel, and AbbVie employees.

Anonymization Standards   To be provided (in process). 
Clinical Study Register or Website  https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.