Charles de Wet, Boehringer Ingelheim’s medical director for the UK and Ireland, says the company is wholeheartedly committed to data transparency but does not favour the approach being adopted by the AllTrials campaign.
The aforementioned initiative believes that all trials past and present should be registered, and the full methods and the results reported. The AllTrials campaign, set up by groups such as Sense About Science, Bad Science, the BMJ and the Cochrane Collaboration, has the backing of a number of healthcare associations but only one drugmaker to date, GlaxoSmithKline.
Speaking at a meeting in London earlier this month, Dr de Wet told PharmaTimes that Boehringer supported the principle of AllTrials but is concerned about the lack of protection its proposals offer for intellectual property. Furthermore, it does not take into consideration the contractual relationships that drugmakers have with academic institutions in terms of databases connected with trials of their treatments.
Dr de Wet gave the example of Boehringer's agreement with McMaster University in Canada regarding the bloodthinner Pradaxa (dabigatran). Not least for reasons of transparency, the German company contracted McMaster to co-ordinate the RE-LY trial that formed the basis of regulatory submissions for Pradaxa as a treatment for stroke reduction.
The upshot of this relationship, Dr de Wet noted, was that McMaster owned the database of over 17,000 patients and “we could not access it without going through a Steering Committee”, he said. A similar agreement is being negotiated with Duke University for the CAROLINA trial comparing Boehringer and Eli Lilly's diabetes drug Trajenta (linagliptin) with the commonly prescribed sulphonylurea glimepiride.
That five-year study is investigating 6,000 patients and recruitment was completed this year. However it is Duke that has responsibility for data analysis and the US university will own the database.