Boehringer Ingelheim has announced that it will publish clinical trial data and other related documents for all approved products going back to 1998. In addition it also pledged to publish data in all instances of a drug’s development being terminated over the same period.
Clinical study reports and other clinical documents can be requested via the Boehringer Ingelheim website, accessible via: http://trials.boehringer-ingelheim.com/trial_results.html
Access to patient level data
Researchers will need to apply to gain access and sign a data sharing agreement. The application will be reviewed by an independent review panel. If successful they will be granted access to a secure analysis environment through the website.
In signing up they will be obliged to use the data for the purpose of their study proposal and must not misuse it by attempting to identify participants or use it for their own commercial interests.
Publication of all scientific data
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 announced in 2013 are now being implemented with the website and the formation of a dedicated team to answer requests.
Announcing the news Charles de Wet, medical director for Boehringer Ingelheim UK and Ireland said
“Boehringer Ingelheim has always had a strong commitment to transparent research-driven innovations in medicine. The free exchange of the scientific information that underpins this is vital to safeguard this process.
“By going beyond our existing obligations and making our data more widely available we can help to build confidence in our company and the wider pharmaceutical industry.
“I feel strongly that this is the correct approach and believe it will benefit science and aid breakthroughs which will make people live longer, healthier lives”.