Boehringer launches new transparency regime
pharmafile | May 12, 2014 | News story | Research and Development, Sales and Marketing | Boehringer, LEO Pharma, all trials, csr, transparency
Boehringer is making good on its 2013 promise to release more clinical trial data to researchers with the launch of a new website designed to ensure more disclosure.
The new policy aims to make clinical study data and other related documents more widely accessible for approved products, or after termination of a drug development programme.
The website access allows clinical study reports (CSRs) and other clinical documents to be requested from the firm dating back to 1998.
This will also enable researchers to request access to de-identified patient level study data which form the basis of clinical trial findings, meaning patients will remain anonymous.
Researchers will be granted access via a secure analysis environment after approval of their study proposal by an independent external review panel, and is 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.
All of these commitments were announced in 2013 as part of its transparency drive but are now being implemented with the website, and the formation of a dedicated team to answer requests.
Redactions
However, documents and data to be shared will be redacted by Boehringer as far as this is necessary to protect both hand personal data of study participants, study personnel, and Boehringer’s employees it says.
It can also be redacted to protect Boehringer’s commercial confidential information, in particular its intellectual property rights.
This may dampen the level to which information can be shared – in fact in April the European Parliament agreed that most new clinical trials will in the next two years become more open, meaning it will no longer be seen as commercial in confidence.
Boehringer is not yet willing to go as far as the EU Parliament would like in rejecting commercial and patent concerns, and it has also not signed up to the British transparency campaign – AllTrials – currently only GSK has done that.
But it is going further than other pharma companies in releasing data by allowing an independent review panel to assess what can be viewed. It joins the likes of Leo Pharma, Johnson and Johnson, Novartis and Sanofi in proactively disclosing higher levels of clinical data before new European laws come into force from 2016.
Peer reviewed journals
In addition, Boehringer also says it is confirming 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 – Phases 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.
Dr Christopher Corsico, global head of clinical development, medicine and regulatory at Boehringer, says: “The free exchange of scientific information is the basis for innovation in medicine. Boehringer Ingelheim as a research-driven pharmaceutical company is committed to the registration of all clinical studies prior to initiation and to disclosing all study results independent of outcome.
“Going beyond applicable regulatory and legal requirements, we at Boehringer Ingelheim feel it is the right approach and hope it will benefit science.”
Ben Adams
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