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Restricting Regulations

Contemporary medicine has come a long way since the days of snake oil salesmen. Today, patients can be assured that prescribed medicine has been vetted for safety and efficacy through a long and arduous process, guided by governmental regulatory agencies. The central pillar of this rigorous procedure for current drug approval is the human clinical trial, the success of which has resulted in a proliferation of studies worldwide. Since the international committee of medical journal editors established trial registration requirements in 2005, enrolment has increased fivefold (1). In the US alone, clinical trial registration has increased tenfold during this same time period, but, against this backdrop, the EU recorded a concerning 25% decrease in clinical trial applications (CTA) from 2007 to 2011 (2).

Global Trials

One of the issues affecting the number of EU studies is a growing trend towards globalisation, with a recent rise in those conducted in developing countries. For example, the number of countries serving as study locations outside the US has more than doubled in the past 10 years, and the proportion of trials undertaken there and in Western Europe has reduced significantly (3,4).

Several factors drive this globalisation trend – one of them being the spiralling drug development costs. A 2013 study by the Tufts Center for the Study of Drug Development estimates the average expense to develop and gain market approval for a new therapeutic is $2.6 billion – up 145% from a similar investigation conducted in 2003 – with time costs accounting for half of that amount. The time and investment required to conduct trials is the largest contributor to these increases, and, given that the success rate for medications moving through clinical trials to FDA approval is a mere 10%, the pharmaceutical industry is struggling to sustain profitability (5).

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Craig Morgan is Head of Marketing at goBalto, a life sciences software as a service technology organisation. He works with sponsors, CROs, medical device manufacturers and sites to reduce cycle times and improve collaboration and oversight in clinical trials. Craig is a technology and life sciences management professional, with over 15 years’ experience in informatics and bioinformatics applications to drug discovery. He holds degrees in analytical chemistry, information systems and business administration and is a certified
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