Over a half a million members of the British public took part in clinical trials through the NIHR Clinical Trials Research Networks in 2010, a 24% increase on the year before. Those are the Government’s figures, not mine.
Last week’s ‘life sciences’ announcement included a range of measures to increase patient recruitment to trials. These include reforms of the rules governing the use of patient data for research purposes as well as other initiatives such as the next phase of development for the UK Clinical Trials Gateway.
Thus far the hoped for increase in clinical trial participation has been viewed only from the research standpoint but with a glance towards distant outcomes of patient benefit as a raison d’etre. But we also need to turn our mind to how we provide appropriate help and support to these growing numbers of patients. It is often said that people on trials receive better care and show better outcomes than if they were not? The evidence is better for the former than the latter but still not that robust.
Talking to patients will reveal many positives in terms of their experience of being on a trial. But concerns and issues do arise, such as the lack of follow-up or feedback after a trial ends. Sometimes things will go wrong; the incident at Northwick Park several years ago being being an example. Looking back on that report now, it is interesting to note that not one of the recommendations really relates to the patients themselves and the learnings we might take from it.
To whom and how a patient can raise concerns is a difficult one to answer succintly and simply. To the clinican, the clinical trial nurse, the NHS? All of the above, most surely but perhaps it is not enough particularly if things go seriously wrong.
There then seems to be a bewildering array of organisations who you could turn to. Some of these might have an interest in your concern but have no license to act or ability to investigate from a patient perspective. Those that you would think would be interested - such as the National Patient Safety Agency (NPSA) – will signpost you elsewhere. Looking to the future the new Health Research Authority (HRA) will have a duty to ‘promote and protect’ the public interest but it’s capacity and capability to fulfil this, will only reach as far as systems and governance I feel.
I wonder whether there is a case for an independent Health Research Ombudsman to investigate matters when things go wrong from a patient perspective, or whether this should be included as part of the brief of the current Health Ombudsman? The same rules might apply in that one would have to show that you had exhausted other routes or that the complaint had been handled unsatsifactorily. But it could be an important route to recourse where currently there seems none. It would also help to improve the evidence base around the patient experience of clinical trials – the Health Ombudsman’s annual report is often quite influential.
Given that the changes being mutedto make everyone a ‘research patient’ require amendment to the NHS Constitution, now might be an opportune time to consider whether it would be in keeping with this change to have a ‘supreme court’ type body of the sort above to protect people’s rights. No, to ensure that people are receiving the very best care.