1.7 The Future of Adaptive Trials in Clinical Drug Development

A recent study released by the Tuft’s Center for the Study of Drug Development suggests that the average pre-tax industry cost to bring a new medicine to market is now around $2.56 billion USD [70]. The study included 106 investigational new drugs from 10 mid- to large-size pharmaceutical companies and the drugs were first tested in humans during 1995-2007. Cost included clinical development up to 2013. By comparison, in 2003, the cost was about $1.04 billion in the 2013 dollars.
DiMasi stated that the higher cost comes from clinical trials that are larger and more complex. In our opinion, some of the higher costs also resulted from increased regulations [70]. For example, since ...

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