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The number of new drugs approved per billion US dollars spent on research and development (R&D) has fallen around 80-fold in inflation-adjusted terms since 1950, despite advances in many of the scientific and technological inputs into the R&D process. Given the apparent lack of impact of proposed solutions to declining R&D efficiency so far, Scannell and colleagues ask whether the underlying problems have been correctly diagnosed and discuss factors that they consider to be the primary causes. The past 60 years have seen huge advances in many of the scientific, technological and managerial factors that should tend to raise the efficiency of commercial drug research and development (R&D). Yet the number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms. There have been many proposed solutions to the problem of declining R&D efficiency. However, their apparent lack of impact so far and the contrast between improving inputs and declining output in terms of the number of new drugs make it sensible to ask whether the underlying problems have been correctly diagnosed. Here, we discuss four factors that we consider to be primary causes, which we call the 'better than the Beatles' problem; the 'cautious regulator' problem; the 'throw money at it' tendency; and the 'basic research–brute force' bias. Our aim is to provoke a more systematic analysis of the causes of the decline in R&D efficiency.

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