Yesterday I attended a really interesting conference at the Wellcome Trust on ‘Increasing openness, transparency and collaboration in the life sciences’ with Sir Mark Walport and Sir Andrew Witty, CEO of GSK. Not the catchiest of titles, but it hid its light under a bushel.
At its heart was the importance of open collaboration. After all, in the UK we have a research ecosystem that is unique in the world, including academia, charities, industry and the NHS but we don’t always work together as well as we could or should.
GSK announced it will share all its anonymised clinical trial data openly through a web app, available to all researchers, for all its trials. And here’s the key thing – that includes both successes and failures.
Both speakers also highlighted the importance of flexible models for intellectual property (IP). That sometimes a protective model for IP is the right route, but sometimes a more open stance will encourage research advance and commercial opportunity.
This chimes well with work that AMRC have under way. On November 26 we’re holding a workshop on IP, where we will debate the different models of IP management and how to choose the right one that encourages innovation. And in January we are holding an industry/charity workshop highlighting how best we can work constructively together.
Both speakers highlighted that openness and collaboration were not only the right moral stance for a sector that relies on public support, but just as importantly, working together and sharing data was good for research outcomes and good for business economics.
Here’s what they said:
- As part of its Neglected Tropical Diseases Theme, GSK will release data for the molecules in its compound library for TB (as it has for malaria already), in attempt to accelerate drug development.
They have decided that whilst there is likely to be little economic benefit for commercial companies in this disease area, there is still really valuable research to be undertaken that may enable researchers to come up with new answers. They will therefore offer free and open access to these compounds to others.
- Of most interest to our sector was the GSK plans to open up, on the web, all their clinical trial data – whether those trials produced positive or negative results.
This means that researchers will be able to access anonymised patient-level data from all studies since 2007, alongside the GSK trial summaries and conclusions. Over time GSK will also release pre-2007 data, as their technology systems allow the app to access it.
Crucially this will include all trials, whether they were successes or failures. We all know that the insight from failure is often more interesting than the insight from success, but it is hard often to secure publication of these studies in key journals. So this is an important advance.
- An independent panel, which will include scientists and patients, as well as other specialists (but no-one from GSK!), will review proposals to use the data to ensure that a legitimate research question is being asked.
It’s great that patients will have the chance to be involved in the panel, as we know that patients are highly motivated for their data to be (responsibly) used. The researcher will have an obligation to publish their outcome – success or failure – but apart from those conditions the researchers will be free to use the data in pursuit of their research.
This is a really interesting development – it recognises that openness is the friend of innovation and causes us to look again at our own preconceptions of IP and how best to manage it.
Intellectual property rights were intended to be a mechanism to reward innovation and risk but they may now becoming a brake on collaboration – just when science, industry and medicine need to pool their brains more effectively to bring research success. The GSK development shows that we might be on the brink of a new way of thinking about rewards to innovation – the old models of IPR and licencing for exploitation may be about to be broken.