Center for Global Research Data

Our Members

Boehringer Ingelheim

 

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).
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 the Boehringer Ingelheim Policy on “Transparency and Publication of Clinical Study Data“, which is available on the Boehringer Ingelheim website. 
Exceptions
  • Clinical studies of rare diseases or single center studies. This is because anonymisation of these data is more difficult to achieve. For these studies Boehringer Ingelheim will assess the feasibility of anonymisation 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). 
  • 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. 
  • For further details, please refer to the Boehringer Ingelheim Policy.   
  • Where compliance with data protection guidelines cannot be ascertained.
When Studies are Available for Sharing 
  • Studies are considered to be listed one year after primary endpoint completion date, after regulatory review has been completed or after termination of the development program and after the primary manuscript describing the results has been accepted for publication. 
  • “After regulatory review has been completed” 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. 
  • For further details, please refer to the Boehringer Ingelheim Policy.
Additional Conditions for Access
  • 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. 
  • Boehringer Ingelheim lists many studies before secondary manuscripts are published, based upon Boehringer Ingelheim’s publication plan. If a research proposal competes with the Boehringer Ingelheim publication plan, Boehringer Ingelheim will decline the research proposal, inform the researcher, and prioritize the planned analysis and publication. Once the Boehringer Ingelheim manuscript has been accepted for publication, Boehringer Ingelheim will inform the researcher and will provide the actual publication. The research proposal can be re-submitted at that time, if the researcher desires. 
  • A condition of sharing data is that the researcher seeks publication of the research results in a peer-reviewed journal. The researcher shall provide Boehringer Ingelheim with a copy of any proposed manuscript prior to submission to a scientific journal in order to give BI the opportunity to provide input regarding medical and scientific accuracy, to provide supplementary scientific information, to object to any inclusion of BI confidential information, and to review for patentable subject matter. The researcher is not required to accept Boehringer Ingelheim’s comments regarding medical and scientific accuracy and supplementary scientific information. 
  •  For further details, please refer to the Boehringer Ingelheim Policy on “Transparency and Publication of Clinical Study Data”, which is available on the Boehringer Ingelheim website.
What information will be Provided Where available, the following anonymized patient level data and information is 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. 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). Appendices which include patient level data are not included as these data are provided in the datasets Boehringer Ingelheim provide. To protect research participants’ privacy and confidentiality, case narratives are not routinely included. They may be provided where they are needed for a specific research proposal, provided research participants’ privacy can be protected.

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.

For further details, please refer to the Boehringer Ingelheim Policy on “Transparency and Publication of Clinical Study Data”, which is available on the Boehringer Ingelheim website.

Questions or Enquires 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.
Review Criteria for Data Requests
  • Whether the regulatory review has been completed or the development program has been terminated, and whether the primary manuscript describing the results has been accepted for publication. (see section “When studies are listed”).
  • Whether 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.
  • Whether Boehringer Ingelheim have 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.
  • Whether Boehringer Ingelheim considers it feasible to anonymise the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.
  • Whether Boehringer Ingelheim considers that there are any practical constraints to providing access to the data. For example, there may be issues related to the size of databases from genetic studies.
  •  The resources (costs) for Boehringer Ingelheim to retrieve data and documents from repositories and archives, anonymise data, and redact personally identifiable information from relevant documents. In some cases, particularly for older studies, the costs could be considerable and Boehringer Ingelheim may turn down requests on this basis.
  •  For further details, please refer to the Boehringer Ingelheim Policy on “Transparency and Publication of Clinical Study Data”, which is available on the Boehringer Ingelheim website.
Data Request Review Process  Access to patient-level clinical study data requires that the requestor submits a study proposal with a sound scientific analysis rationale of potential public interest, which will be reviewed and approved/rejected by an independent external review panel consisting of acknowledged experts. The review panel will consider 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)
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   Anonymization Standards
Clinical Study Register or Website Boehringer Ingelheim registers all of its local and global studies, including non-interventional and Phase I studies, and legacy studies initiated after 1 January 1998, on  ClinicalTrials.gov.