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Alliterative descriptions of pharmaceutical industry R&D have transformed over the last 20 years, from a benign but critical ‘slow and sleepy’ to the assertive and flattering ‘fast and furious’. This dramatic change was at least in part driven by the introduction of ‘time-based competition’, a methodology championed by the Boston Consulting Group within the pharmaceutical industry, which educated R&D executives about the huge opportunity costs involved in slow, linear development techniques and demonstrated the need to speed up both overall drug development and individual trial processes. A key implication of this method of operating was that pharmaceutical companies needed to have clear control over the process of managing each trial, rather then cede power to opinion leaders whose priorities differed. As a consequence, today’s R&D programmes are leaner, faster and more targeted towards commercial objectives.

In parallel, the surge of outsourcing, from essentially zero to a substantial 22 per cent (or more) of all clinical trials, has provided pharmaceutical companies with access to a much larger and commercially developed infrastructure in which to run trials than any individual company could possibly hope to achieve on their own. Furthermore, the outsourcing concept opens up the R&D process to market pressures as contract research organisations (CROs) compete to deliver faster and at a lower cost than their competition.