Boehringer Ingelheim to Make Clinical Trial Data Available

May 14, 2014
By PharmTech Editors

Boehringer Ingelheim announced that it is working on a program to make clinical trial data and other related documents more widely accessible for approved products and drug-development programs that have been terminated. These reports and documents can be requested via the company’s website. Researchers will also be able to request access to de-identified patient-level study data that form the basis of clinical trial findings. Data and documents relating to studies initiated back until the year 1998 will be made available.

Boehringer Ingelheim has also confirmed that it is committed to publishing results from all its sponsored studies in peer-reviewed journals and at scientific meetings, regardless of the study outcome. Findings will be submitted for publication no later than 12 to 18 months after completion of the clinical trial. The company announced these commitments in 2013 and is now working on the website and the formation of a team to answer requests.

Dr Christopher Corsico, global Head of Clinical Development, Medicine and Regulatory at Boehringer Ingelheim, commented in a press statement that the free exchange of scientific information is the basis for innovation in medicine. He adds that Boehringer Ingelheim is committed to the registration of all clinical studies prior to initiation and to disclosing all results independent of the outcome.

The company announced that it will extend protocol registration to studies initiated 1998 or later. Starting with studies completing in 2014, results will be posted on ClinicalTrials.gov for products approved outside the US and from terminated drug-development programs.

Source: Boehringer Ingelheim