FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

Phase III Trial Costs Estimated at $19 Million

Sept. 26, 2018
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It cost an average of $19 million to get new drugs through their pivotal clinical trials and onto the market, a new analysis has found.

Researchers at George Washington and Johns Hopkins reviewed 59 separate drugs or therapies approved between 2015 and 2016 and analyzed their costs based on estimates from IQVIA software. They found costs varied widely, from $12 million to $33 million per trial.

The researchers focused on successful trials but said one lesson learned is that trials for novel drugs don’t have to break the bank.

The researchers identified three key elements that were likely to drive up costs: First, if the trial needed large patient pools; second, if the trial required the control group to take an active drug rather than a placebo; and third, if the trial focused on clinical rather than on surrogate endpoints.

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