Boehringer Ingelheim to make available detailed clinical trial data
In order to add to scientific and medical progress, Boehringer Ingelheim has launched a program to make clinical study data and other clinical study-related documents more widely accessible for approved products or after termination of a drug development program.
Clinical study reports and other clinical documents can be requested via the Boehringer Ingelheim web site. The web site also will enable researchers to request access to de-identified patient level study data which form the basis of clinical trial findings.
Researchers will be granted access via a secure analysis environment after approval of his/her study proposal by an independent external review panel and based on a data sharing agreement. This agreement will include obligations such as the commitment to use the data only for the purpose of the study proposal, to not attempt to identify study participants, to not misuse the data (e. g. for own commercial interests) and to be "transparent" regarding the planned analysis and disclosure of results.
Documents and data to be shared will be redacted by Boehringer Ingelheim as necessary to protect study participants, study personnel and Boehringer Ingelheim employees and to protect Boehringer Ingelheim's commercial confidential information, in particular intellectual property rights.
Data and documents relating to studies initiated back until the year 1998 will be made available.
In addition, Boehringer Ingelheim confirmed its commitment to publish the scientific results from all sponsored studies in peer reviewed journals and at scientific meetings, regardless of study outcome for all types of clinical studies, phase I- IV, interventional and non-interventional. Key Publications of phase III clinical studies are being submitted to indexed, peer-reviewed journals no later than 12 to 18 months after completion of the clinical study.
These commitments were announced in 2013 and now are being implemented with the web site.