Low-value approvals and high prices might incentivize ineffective drug development

An Addendum to this article was published on 12 November 2018

Drug regulators’ acceptance of any statistically significant improvement shown in a single randomized trial and lofty drug prices has created a situation where it is now, hypothetically, profitable for a company to run a clinical trials portfolio of chemically inert compounds. While the current cancer drug pipeline is certainly superior to inert drugs, we must rethink market incentives to encourage transformational drug development.

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Fig. 1: Break- even point at which a null trials agenda would turn a profit based on one or two nominally significant randomized trials.


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Correspondence to Sham Mailankody.

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Prasad, V., McCabe, C. & Mailankody, S. Low-value approvals and high prices might incentivize ineffective drug development. Nat Rev Clin Oncol 15, 399–400 (2018). https://doi.org/10.1038/s41571-018-0030-2

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