With 25% of clinical trial procedures recently being branded 'pointless', could mobile health and real-world evidence signal the turning point in successful product trials?
The recent release of the Medidata and Tufts University School of Medicine report on clinical trials makes for sobering reading.
The findings, that up to a quarter of clinical trial procedures are a waste of money is a big deal in the current economic climate. Clinical trial costs keep rising and money doesn’t come as easy as it used to, so there is an urgency to act on findings like this. But how?
In many ways, this report is frustrating. It’s all very well doing retrospective analysis of drug trials and determining what has and hasn’t been of use, but it’s much harder to predict this at the outset of the trial. As Michelle Marlborough, director of product management at Medidata, has said, "There seems to be a fear in organisations of not having data if it is requested by the regulators, and so that drives a culture of collecting data ‘just in case’”.
But where is the solution for dealing with this culture of fear – and a fear, we might add, that is well-founded?
Considering the many more millions that will be lost if regulators make a last minute objection to a trial that results in the need for an entirely new one, many drug companies may consider the estimated US$1 million a necessary, if expensive, piece of insurance. It is not like an illogical fear of the dark. Although I maintain that this is a very sensible fear too. It just is. And the rather vague advice from the report that more ‘forward planning’ is necessary, is almost as unhelpful as commenting on the ‘climate of fear’, without offering any concrete ways of dealing with what is a real problem.
But fear [ha!] not – this is where mHealth can come in.
There are three strings to this particular mobile health bow. First, the Vodafone and Exco InTouch deal announced last month, which marks the launch of a new mobile-enabled clinical trial offering that uses Exco’s patient-reported outcomes software. This is an immediate and exciting way to lower costs to a far greater and far more concrete extent than the suggestions to implement more ‘forward-planning’. To be clear: I’m not dismissing forward-planning entirely. Forward-planning is always a plus. But drug companies are already forward-planning and already constantly looking for ways to slimline the cost of trials. Something more radical and more tangible is needed, and this partnership could provide it.
This software has in fact already been tested in Pfizer’s online clinical trial. And yes, that clinical trial didn’t prove an outright success, but it’s early days, and there were far more obvious contributory factors to its demise than its use of mHealth. Added to this are the recent findings that use of mHealth to monitor patients radically improves patient behaviours, indicating that it really is possible to recreate the clinical trial remotely.
But perhaps most importantly, is the potential for marrying traditional clinical trials with real world evidence, which has, in recent years, attracted serious attention. The criticisms of clinical trials are well-known – the setting is unreal, and cannot predict how patients will actually behave. Secondly, the segment of the population that is attracted to clinical trials is not always representative of the actual patients who will suffer from the disease. mHealth provides an opportunity to spread the net more widely and capture more accurate data.
Most exciting, however, is the potential for the ultimate erasure of the discrepancy between clinical trials and the ‘real world’. Since some hospitals are already using mHealth to great effect to reduce hospital readmissions, it seems inevitable that more and more health centres around the world will follow suit.
This being the case, we could soon find that clinical research conducted by mHealth, and patient monitoring conducted by mHealth become two sides of the same coin. And what a saving of life and money that coin could represent.
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