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International Clinical Trials

Gaining Control

Changing the model for running and recruiting for clinical trials may sound like a stressful, time-consuming operation, but the benefits of ‘cleaner data’ make for a convincing case, argues Dr Ian Smith of Synexus

Concerns over safety are driving regulatory authorities to demand larger clinical trials. More and more trials will have safety as a key parameter and will consequently need significantly more patients than before. In order to achieve these numbers, pharma needs to radically rethink the way in which it recruits and retains patients for clinical trials because the current, and perhaps outdated, model is struggling under the pressure. The pharma industry also needs to address the issue of delivering studies ‘on time’. Clinical trials represent the single largest cost for drug development, with patient recruitment a key element in that process. Despite this, 70 per cent of trials fail to deliver on time.

Patient recruitment and retention represents a major bottleneck of drug development and, considering many candidate compounds never even make it to market, ways to increase the efficiency of later stage clinical trials have become an important quest for the industry.

With this goal in mind, unique models for patient recruitment and the management of later phase clinical trials are in development. In appropriate therapeutic areas, such a model has the potential to move the business of patient recruitment and the management of clinical trials from a cottage to a professional industry. The new models can respond directly to the changing market and the extreme pressures being faced by the pharmaceutical industry. They can offer an alternative, effective and proactive method that is far more in sync with today’s pharmaceutical industry. Could this be the new model that the pharma industry has been seeking?

THE CHANGING LANDSCAPE

The pharmaceutical industry is changing and, therefore, the clinical trials market must follow suit. Patent protection for many established drugs is coming to an end. Companies are under pressure to boost pipelines in order to keep pace with rivals in the race for scale. The average cost of bringing a new active substance to market sits at around US$1 billion per compound. This figure is increasing, whilst the number of new active substances is declining. Pipelines are not growing and the output of marketed new active substances is static. Total development times to launch have increased, thus eroding the length of patent protected marketing time resulting in lost sales income of tens of millions of dollars.


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Dr Ian Smith is founder and Medical Director of Synexus, a company that recruits patients and runs clinical trials at 14 hub sites in the UK, Poland, Bulgaria, Hungary, India and South Africa. As a General Practitioner, he took part in clinical trials as an investigator. Ian started Synexus in Chorley in 1991 at a clinical trials centre adjoining his surgery. Last year, he was recognised for his pioneering work by the Institute of Clinical Research with the Outstanding Achievement Award.
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Dr Ian Smith
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