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.

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

• 12 months after the global end of trial date
• 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.

Legacy Allergan studies are not yet listed on Vivli.  They can be identified on AbbVieClinicalTrials.com, ClinicalTrials.gov and/or the EU Clinical Trials Register.

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  the Independent Review Panel members according to their charter.

• 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

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

🗹 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.

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. Researchers can access CSRs that have been publicly disclosed via EMA Policy 70 or Health Canada Public Release of Clinical Information.

Clinical Study Report Synopses, a brief summary of the study results, are posted on the AbbVie Clinical Trials Scientific Result Summaries.

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

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.