As the issue of transparency returns to the spotlight, GlaxoSmithKline has announced plans to be more open about its clinical trial data.
Speaking at a meeting hosted by the Wellcome Trust in London, the drug giant’s chief executive Sir Andrew Witty has outlined a number of initiatives the company is taking to extend what it describes as its ‘open innovation’ approach to R&D.
Arguably the most striking move is that it will create a system that will enable researchers “to access the detailed anonymised patient-level data that sit behind the results of clinical trials of its approved medicines and discontinued investigational medicines”. Researchers will submit requests which will be reviewed for scientific merit by an independent panel of experts and access will be granted via a secure web site.
GSK says this will enable researchers to examine the data more closely or to combine data from different studies in order to conduct further research. The firm has also committed to seek publication of the results of all of its clinical trials – “regardless of what the results say – to peer-reviewed scientific journals”.
TB library opened
GSK also noted that its scientists have screened the company’s entire library of more than two million compounds for any that may inhibit tuberculosis bacteria and will publish the results of this process. It has come up with “about 200 promising hits that could act as new starting points for the discovery of new medicines” for the disease.
This is the first time a pharmaceutical company will have made public its own compounds which have demonstrated signs of activity against TB, said GSK, noting that it set up a similar initiative for malaria in 2009.
The company added that it will double its funding for its ‘open lab’ at Tres Cantos, Spain, awarding it an additional £5 million. It was established in 2010 to allow independent researchers “access to GSK facilities, resources and knowledge” and the company notes that there are projects underway at Tres Cantos looking at TB, malaria, Chagas disease, leishmaniasis and sleeping sickness.
Sir Andrew said: “I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges. However, the complexity of the science and the scale of the challenge mean that we cannot solve these problems alone”.
He went on to say that “we need to take a different approach – one focused on partnership, collaboration and openness [and] by being more open with our clinical trial data, we also hope to help further scientific understanding”. Sir Andrew concluded by saying that “I am pleased with the progress we have made so far to evolve our business model but we recognise there is more we can do”.
Sir Mark Walport, director of the Wellcome Trust, said that GSK is “setting an example of how the pharmaceutical industry must adapt to help drive forward medical advances. Real breakthroughs do not come out of nowhere, but are borne of scientists sharing their knowledge and learning from each other”.
He added that “GSK’s moves are bold and innovative, a very positive sign of its commitment to tackle some of the greatest health challenges facing the world today”.
