Data transparency
Our commitment on transparency and publication of clinical study data
As a research-driven pharmaceutical company, Boehringer Ingelheim supports the principle of free exchange of scientific information as the basis for innovation in medicine, especially the exchange of scientific results from clinical studies in humans.
It is our goal to benefit patients and public health, and to enable healthcare providers, patients, payers, and other stakeholders to make informed decisions about Boehringer Ingelheim’s products.
Registry and results disclosure
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.
Since 27 September 2007, Boehringer Ingelheim follows the FDA Amendment Act requirements regarding the posting of structured study results on ClinicalTrials.gov. These requirements include the description of study design and methodology, results of primary and secondary outcome measures, as well as safety data.
Following EU directives, interventional studies of Boehringer Ingelheim initiated after 2004 are made public on EU Clinical Trial Register.
In general, results are posted one year after end of study.
Study report summaries (synopses)
Data and document sharing
With our commitment to responsible sharing of clinical study data and documents, we respect the boundaries of the informed consent. We ensure the protection of personal data of study participants and personnel as well as the protection of commercially confidential information.
We provide redacted clinical study reports and clinical documents upon request. Furthermore, we offer scientific and medical researchers access to de-identified, analyzable patient-level clinical study data.