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Center for Global Research Data

Our Members

AbbVie

About Research and innovation are the cornerstones of AbbVie 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, Neuroscience, Oncology, Virology, Aesthetics, Eye Care, and Other Specialty Areas.

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.

How We Share on the Vivli Platform AbbVie studies that are available for data sharing are listed on Vivli. Data requestors should use the Vivli Data Request Form to request data package(s).
Studies Listed for Sharing  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, and from legacy Allergan products Phase II-IV interventional clinical studies in patients completed after 2008, for commercially available medicinal products and indications that have received an initial marketing authorization.

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

When Studies are Available for sharing Studies are available for sharing when all the following criteria are met:

  • 12-18 months after the global end of trial date
  • 6 months after the studied product and indication have been approved by regulatory authorities in the following countries/regions:
    • 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)
  • the study is not part of an ongoing or planned regulatory submission in the regions listed above
  • after the primary manuscript describing the results has been accepted for publication

AbbVie may choose to proactively share studies beyond the criteria noted above.

Data Request Review Process Access to data is determined based on the business feasibility to support the request and the scientific merit of the research proposal.

Proposals that have been received via Vivli will be reviewed by AbbVie for business feasibility. Proposals that are feasible to support are then reviewed for scientific merit by Wellcome Trust Independent Review Panel members according to their charter.

Review Criteria for Data Requests When a study is requested, the data is reviewed to ensure it is feasible to share. The following criteria must be met:

  • the data is not subject to legal, contractual or consent provisions that prevent further sharing of data
  • there are no 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)
  • the data can be readily anonymized
  • there is not a reasonable likelihood that a patient could be re-identified (for example, clinical trials with a very small number of patients)
  • study documentation is in English
  • the research objective can be met with the collected study data
Exceptions Access to data may be declined where there is a potential conflict of interest or an actual or potential competitive risk.

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

Additional Conditions for Access A Data Use Agreement (DUA) with each research team member’s institution must be executed prior to the researcher being able to access data within the Vivli platform.
What information will be provided Where available, the following anonymized patient level data and information is provided for each clinical study:

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

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

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

🗹 Clinical Study Report Synopses – This is a brief summary of the study results.

🗹 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.

*All AbbVie data sets will be provided in SAS format. The Vivli team will address conversion to .CSV format in the research environment guidance. Data is generally not permitted to be downloaded unless there is a compelling research reason, which must be addressed in the proposal.

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.
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.

Clinical Study Report Synopses, a brief summary of the study results, are posted on the AbbVie company website.

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

Anonymization Standards   We use various risk management practices and prioritize privacy and confidentiality of research participants for creation of anonymized datasets and clinical study documents. We seek to promote the utility of research participant’s data in progressing medical research to its full while fulfilling our legal and ethical obligation to ensure compliance with data privacy and legal requirements.

Our anonymization process is derived from data privacy laws, regulatory guidance, and industry best practices provided by organizations such as PhUSE, TransCelerate. Our process undergoes updates as knowledge, tools and best practices continue to evolve.

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.