For years, the pharmaceutical industry has maintained that the costs to develop medicines accounts for rising prices. But a new analysis contends that expenses for at least one crucial component of drug development — the clinical trials — are actually modest.
After examining 101 new medicines that were approved by the Food and Drug Administration from 2015 through 2017, researchers found a median cost for clinical trials of $48 million per drug, with costs ranging from $20 million to $102 million. The 225 pivotal trials used to support approvals had a median cost of $19 million, or roughly $41,400 per patient, according to the analysis, which was published in BMJ Open.
The largest single factor driving the cost of clinical trials was the number of patients required to establish a drug was effective, followed by the number of visits to study clinics. Overall, costs were lower when the FDA waived its standard requirement to conduct two trials and accepted just one trial. Costs were highest when a company conducted several separate trials for different disease conditions.
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