Twitter Facebook LinkedIn
Center for Global Research Data

Our Members

Boehringer Ingelheim (BI)

About Boehringer Ingelheim is a global, research-driven pharmaceutical company embracing many cultures and diverse societies, improving the health and quality of life of patients.
How we share data on the Vivli Platform Studies available for sharing will be listed and searchable on the Vivli platform. Data requestors should use the Vivli Data Request Form to request Boehringer Ingelheim data package(s).

If the request is approved, researchers will need to sign a Data Use Agreement. The anonymized data and redacted documents will be provided in a secure research environment on Vivli to further protect participant privacy.

Studies Listed for Sharing  This listing reflects study data made available by Boehringer Ingelheim on the Vivli Platform and that are being prepared for data sharing. Request for access to additional study data sponsored by Boehringer Ingelheim will be considered on a case-by-case basis, per our commitment on transparency and publication of clinical study data available on Boehringer Ingelheim’s transparency website.
Exceptions
  • Clinical studies of rare diseases or single center studies. This is because anonymization of these data is more difficult to achieve. For these studies Boehringer Ingelheim will assess the feasibility of anonymization as part of the review of enquiries, and/or will try to address requests by providing summary data or otherwise.
  • Boehringer Ingelheim does not provide data and reports for pharmaceutical formulation studies and associated analytical methods, and for studies pertinent to pharmacokinetics using human biomaterials, since we believe that the reports and data for such studies primarily contain commercially confidential information (CCI) and intellectual property (IP).
  • Boehringer Ingelheim does not share case narratives, image data (e.g. x-rays, MRI scans), genetic/genomic data or other information that Boehringer Ingelheim considers may compromise trial participant privacy.
  • For some studies, Boehringer Ingelheim is collaborating with academic centers for the analysis and publication of study results. In these cases, inquiries might be referred to these centers.
  • Where compliance with data protection guidelines cannot be ascertained.
Questions or Enquiries Researchers may inquire about the availability of data from Boehringer Ingelheim clinical studies that were not listed on the site by completing an Enquiry Form.
When Studies are Available for Sharing  Studies are considered to be listed:

  • one year after primary endpoint completion date AND
  • after regulatory review has been completed (this typically refers to the completion of the regulatory reviews and approvals in EU and US, but might for example also apply to the completion of the review and approval by other regulatory authorities for a dedicated national study, etc.) or after termination of the development program AND
  • after the primary manuscript describing the results has been accepted for publication.
Additional Conditions for Access
  • Study was initiated after January 1st, 1998.
  • Boehringer Ingelheim is able to provide the requested data. For example, the majority of non-interventional (or observational) studies use data from third party databases under license agreements which prevent Boehringer Ingelheim from providing access to the data. Researchers can request access data directly from these third party databases.
  • Boehringer Ingelheim has the legal authority to provide the data. For example, Boehringer Ingelheim may not have the legal authority because the medicine has been out-licensed or the license may have been returned to another company.
  • Boehringer Ingelheim considers it feasible to anonymize the data without compromising the privacy and confidentiality of research participants. For example, anonymization of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.
  • The researcher seeks publication of the research results in a peer-reviewed journal providing Boehringer Ingelheim with a copy of any proposed manuscript prior to submission.
  • Responsible data sharing must respect the boundaries of the informed consent of study participants and data protection regulation. In rare cases, the limitations of the informed consent of study participants might not allow data sharing. In such cases, Boehringer Ingelheim will try to address requests by providing summary data or otherwise. When patients agreed to take part in Boehringer Ingelheim clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease Boehringer Ingelheim were researching. Further research must therefore study the medicine or disease that was researched in the original studies. For studies Boehringer Ingelheim initiated from 2014, patients are asked to give permission for broader research so other research will be possible with data from these studies.
Review Criteria for Data Requests
  • The analysis can be conducted in the data access system.
  • The scientific rationale and relevance of the proposed research to medical science or patient care.
  • The qualifications and experience of the research team to conduct the proposed research.
  • If a research proposal competes with the Boehringer Ingelheim publication plan, Boehringer Ingelheim will decline the research proposal and inform the researcher accordingly. The research proposal can be re-submitted at time of publication, if the researcher desires.
Data Request Review Process  Access to patient-level clinical study data requires that the requestor submits a research proposal with a sound scientific rationale which is reviewed by Vivli and Boehringer Ingelheim for completeness and for compliance with the access and review criteria listed above. Furthermore, an independent external review panel consisting of acknowledged experts will review the proposal considering the following:

  • The scientific rationale and relevance of the proposed research to medical science or patient care.
  • The ability of the proposed research plan (design, methods and analysis) to meet the scientific objectives. This is a high-level review.
  • The publication plan for the research.
  • Real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research and proposals to manage these conflicts of interest.
  • The qualifications and experience of the research team to conduct the proposed research (a statistician with a degree in statistics or a related discipline should be part of the research team)
What information will be provided Where available, the following anonymized patient level data and redacted documents are provided for each clinical study:

🗹 Raw dataset. This is the data collected for each patient in the clinical study.

🗹 Analysis-ready dataset. This is the dataset used for Boehringer Ingelheim’s analysis.

🗹 Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study. The protocol is part of the appendices of the clinical study report.

🗹 Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.

🗹 Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) Boehringer Ingelheim used for the study.

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

🗹 Clinical study report without appendices. 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) and the European Medicines Agency (EMA).

Documents will be redacted to protect personal data of study participants, study personnel, and Boehringer Ingelheim employees, and to protect Boehringer Ingelheim’s commercially confidential information, including intellectual property rights.

Access to study documents without participant-level data If you are interested in Boehringer Ingelheim clinical study documents only, without patient-level data, click here to request access.
Anonymization Standards   BOEHRINGER INGELHEIM GmbH
Clinical Study Register or Website All Boehringer Ingelheim studies initiated after 1998 are registered on the US National Library of Medicine’s website ClinicalTrials.gov. New interventional and observational studies are registered before study start