Opening up the possibilities

18 January 2013

Patient participation in clinical trials is crucial to medical research, but more transparency is needed to retain the public's trust, says NIHR CRN Chief Executive Dr Jonathan Sheffield

Clinical research is vital to the NHS. Not only is it the best way to collect robust evidence about 'what works', so that we can improve the quality of care for patients, it is the catalyst for innovation, and the means through which we can identify ways to become more efficient and meet the challenges of an ageing demographic and increased demands on the health service.

Patients certainly recognise the value of a research-active NHS. According to a 2012 national consumer poll, 82% of those surveyed stated that it was important for the NHS to offer opportunities to take part in healthcare research – a finding borne out by the growing number of NHS patients who now participate in clinical research studies. Last year, this figure topped 595,000 people, the highest since systematic records began.

The Treasury also sees the value of clinical research, since the commercial life sciences industry, which depends on clinical research, has been identified as one of the key sectors to support domestic economic growth now and for the future.
So given that there are clear economic drivers and high levels of public support, it can be no surprise that politicians are keen to explore ways to drive the clinical research agenda to new levels, by providing researchers with access to the richness of patient data available in NHS organisations – in anonymised form.

'Opening up' the NHS to researchers in this way would put the UK in the vanguard as a global clinical research destination, and work is already well under way on sophisticated IT systems to join NHS databases together and make them accessible as a research resource.

But such advances come with responsibilities attached. Security and anonymity of patient data is obviously the paramount responsibility, but it is not the only one. Surely the other 'given' is that researchers who access NHS patient data (whether from the academic or commercial sphere) should be obliged to publish their findings so that others might learn from them. If the public has contributed (albeit electronically and in an anonymous way) to developing our scientific understanding, then the public should also have a right to expect that this understanding will be publicly shared. Only by doing this can we avoid duplication of effort, minimise waste of public resources and encourage the open and investigative attitude that fuels further advances in medical treatment.

This may seem obvious, but debate around the publication of research findings has never been fiercer – especially in relation to the publication of data from commercial clinical trials. The British Medical Journal Editor Fiona Godlee is heading a campaign for open data to encourage commercial companies to make their clinical trial data routinely available for independent scrutiny. Author and journalist Ben Goldacre has also written about the need for life sciences companies to be more transparent in his book 'Bad Pharma', and a number of politicians have begun to add their voices to the public debate.

Some life sciences companies have already begun to address this issue of data access. For example, GlaxoSmithKline has announced recently that it will allow access to anonymised patient-level data from its clinical trials. However, others are being more reticent.

Still, it is unfair just to target the commercial life sciences sector with a demand for transparency. Academic researchers who engage NHS patients in their research should also be obliged to publish their results, particularly if they have received public funding for the research project. After all, patients who agree to take part in clinical studies make no distinction between the types of sponsor, so the obligation to share knowledge that has been derived from public participation should be the same.

There is an opportunity for the public sector to lead the way on the issue of transparency, and the National Institute for Health Research has already been taking steps to stay ahead of the debate. Early in 2013, it will launch the NIHR Journals Library – a suite of journals covering the findings from five major-scale research funding programmes. The Journals Library will provide a permanent record of the work that has been funded by the NIHR, as well as a full account of the researchers' methods and results. The fact that this service is online, and therefore easily accessible and searchable, makes it a valuable resource for the research community.

With 99% of NHS trusts now engaged in some level of clinical research, this question of who owns the results, and who should be able to access them, is unlikely to go away. From my own perspective, I believe we should recognise our duty to the patients who participate in clinical studies. Patients take part in research, for completely selfless, altruistic motives, to help us to develop our understanding of medical conditions, and they expect that their involvement will contribute to a public – unrestricted – body of knowledge. If we want to maintain the public's trust, and keep extending the number of patients who participate in clinical research, we owe it to them to make all findings accessible.