FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

New Big Data Study From MIT Puts Clinical Trial Success Rate at 14 Percent

Feb. 5, 2018
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Nearly 14 percent of all drugs in clinical trials eventually win approval from the FDA — a much higher percentage than previously thought, according to a new study from the MIT Sloan School of Management.

Approval rates ranged from a high of 33.4 percent for vaccines for infectious diseases to 3.4 percent for investigational cancer treatments. Previous estimates placed overall success rates, from Phase I through to FDA approval, between 9 and 11 percent.

The research was based on Informa’s Citeline dataset, which contains more than 400,000 entries corresponding to 185,994 unique clinical trials of over 21,000 compounds. Automated algorithms traced each drug’s development path, and determined the probability of success within a matter of hours, MIT said. ClinicalTrials.gov contains over 217,000 clinical trial entries, by comparison.

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