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  Studies qualify for a listing if the following criteria are fulfilled:

  • Phase I to IV interventional as well as non-interventional studies
  • Studies initiated after 1 January 1998
  • Studies for which Boehringer Ingelheim received drug approval or where the drug development program was terminated
  • Studies, where data is available in Boehringer Ingelheim’s Clinical Trial Data Database (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 a particular study. In some cases, contractual obligations vis-à-vis third parties or other restrictions may not allow sharing documents or data (e.g. medicine has been out-licensed).
  • 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.
Exceptions
  • Clinical studies of rare diseases or single center studies. Anonymization of these data is often not feasible without compromising the privacy and confidentiality of research participants. 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.
  • Pharmaceutical formulation studies and associated analytical methods, as well as studies pertinent to pharmacokinetics using human biomaterials. Boehringer Ingelheim believes that the reports and data for such studies primarily contain commercially confidential information (CCI) and intellectual property (IP).
  • 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.
  • Studies, where 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 structured results have been posted on Clinicaltrials.gov 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.
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.
  • The data requested in the research proposal are available
Additional Conditions for Access
  • 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.
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 reviews the proposal and considers, among other things, the scientific rationale and relevance of the research and the qualifications of the research team (see Independent Review Panel for more information)
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, without patient-level data, please complete the Vivli Enquiry Form, indicating, that only documents are requested.
Anonymization Standards   Data Protection Procedures for Individual Patient Data
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