Clinical Research - Successful site selection

Successful site selection

Mark Evans describes a new approach to maximise the site selection process for anyone involved in the placement and provision of clinical trials sites in the UK

Sixty years ago, British Steel, British Shipbuilding and British Coal were world leaders and cornerstones of the UK economy. It would have been inconceivable at the time to imagine they could face such rapid decline within one generation. It is equally unbelievable to think that it was only 60 years ago that the Medical Research Council helped to ignite the embryonic clinical trials industry by pioneering the first ever trial using properly randomised treatments. However, while the UK spent the latter half of the 20th century developing a highly credible name in research, it paid scant attention to the growing threat to its clinical trials industry.

The demise of Britain’s three key industries had several contributory factors in common – more effective overseas competition, ineffective government action, and lack of adaptation or flexibility within each industry. At the turn of this century the fate of the UK clinical trials industry looked set to follow, with Department of Health data for the first seven years of this millennium showing a threefold drop in UK contribution to global trials, from 6% in 2000 to just 2% by 2007. But this time the government had learnt the lessons of history – even if it was something of a late education – and under pressure from industry, several key initiatives were introduced:

Setting up the National Institute for Health Research (NIHR) and ring fencing a significant budget
A commitment to double the number of NHS patients involved in trials over the next five years
Production of a new, single national method for gaining approval to conduct trials (in June 2009 the time from first submission to first patient visit was an average of 187 days, according to ABPI data)
Production of the NHS constitution to make research a core function of the NHS

The Potential/Propensity concept

But by using mathematical modelling employed in commercial scenarios clinical trial site identification could be dramatically improved. At the heart of this development are two key concepts, ‘Potential’ and ‘Propensity’, which may be combined in a mathematical process, such as Clinical Site Investigator (CSI).

So how does it work? ‘Potential’ is the simpler of the two concepts, and refers to the amount of relevant trial disease to which each site – primary or secondary – has access. ‘Potential’ should be the starting point for any trial site identification, as sites with a high level of relevant disease are clearly preferable.

When ‘Potential’ is combined with ‘Propensity’ – which is the likelihood of the site to recruit the ‘Potential’ in the time available – this becomes a powerful tool.

As the CSI table opposite demonstrates, sites that fit into the top right segments – by having both a high degree of disease and an ability to recruit patients – are desirable. Those with either a low degree of disease, low propensity or worse, a combination of both, are to be avoided. The art to establishing each segment lies in apportioning an effective value to each axis via appropriate data analysis. In basic terms this is a ranked list of sites for ‘Propensity’ and ‘Potential’ which is then combined to produce appropriate segments. The CSI approach relies on effective data collection combined with information triangulation, regression analysis and extensive testing.

The key to success is in understanding what data is available, how to collect it and how to model it. In the modern NHS with data quality at its heart, this is now possible, but the hard evidence – that 35% of sites are still failing to recruit patients – suggests this is not being followed.

Every trial will require different data and modelling, but if we are to avoid the fate of the shipbuilding, coal and steel industries, then sites and selection of the best sites must improve: being able to measure performance is merely the first step on this journey.

To find out more about Clinical Site Investigator methodology and data comprehension contact: mark.evans@nhis.info

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