Importance The mean cost of developing a new drug has been the subject of debate, with
recent estimates ranging from $314 million to $2.8 billion. Objective To estimate the …

Importance Drug companies frequently claim that high prices are needed to recoup
spending on research and development. If high research and development costs justified …

Importance A critical question in health care is the extent of scientific evidence that should
be required to establish that a new therapeutic agent has benefits that outweigh its risks …

Background: The increasing cost of clinical research has significant implications for public
health, as it affects drug companies' willingness to undertake clinical trials, which in turn …

Background Debate over the viability of the current commercial research and development
(R&D) model is ongoing. A controversial theme is the cost of bringing a new molecular entity …

Objectives Little is routinely disclosed about the costs of the pivotal clinical trials that provide
the key scientific evidence of the treatment benefits of new therapeutic agents. We expand …

OBJECTIVES: We aimed to systematically review and assess published estimates of the
cost of developing new drugs. METHODS: We sought English language research articles …

Over the years, questions have been raised over R&D costs of new medicines. The aim of
this study is to conduct a landscape review of the (drivers of) R&D costs of a new medicine …

Importance Clinical trial evidence used to support drug approval is typically the only
information on benefits and harms that patients and clinicians can use for decision-making …

This paper replicates the drug development cost estimates of Joseph DiMasi and colleagues
(“The Price of Innovation”), using their published cost estimates along with information on …