Phase 3 Trial Costs Estimated at $19M, Study Finds

Regulatory NewsRegulatory News | 26 September 2018 |  By 

The cost of a Phase III clinical trial ranges widely, though a new study pegs the median cost of 138 clinical trials in 2015 and 2016 at $19 million.

“This study identified more than 100-fold differences in the costs of pivotal trials that the FDA required to provide substantial evidence of benefit, with a central cluster of trials with estimated costs of $12.2 million to $33.1 million,” Thomas Moore of the Institute for Safe Medication Practices and others from Johns Hopkins wrote in JAMA Internal Medicine on Monday. “Costs were increased when larger patient enrollments were required to detect a difference from placebo or active drug comparator, and costs were highest when a new drug had to be proved to have clinical benefit that was noninferior to another drug already available.”

In addition, the researchers found that the clinical trials cost a median of $41,117 per patient and $3,562 per patient visit.

But perhaps more important than the median costs, Moore et al said the study provides “a different perspective to the widely held assumption that elaborate and expensive clinical trials are the main reason for the high costs of developing a new drug. These data suggest that high-cost trials occur but usually when drug effects are small or a known drug already provides clinical benefit. On the other hand, pivotal trials for novel drugs with substantial clinical benefits can be conducted at a lower cost.”

In an accompanying editorial, Joseph Ross of Yale University School of Medicine noted the wide range in estimated costs, saying the study “should not be misinterpreted as an estimate of drug development costs and has important limitations because it was focused solely on pharmaceuticals approved in 2015 and 2016 and on individual pivotal trial costs instead of the aggregate evidence used to secure FDA premarket approval or to satisfy postmarketing requirements.”

He also noted that the study suggests that the stronger the evidence that is generated, the more it costs.

“We get what we pay for, and high-quality clinical trial data are well worth the investment to be sure that we prioritize spending our health care resources on therapies that have been shown to benefit patients,” Ross wrote.

PhRMA, meanwhile, took issue with the study, saying that it fails to take into account unsuccessful drug candidates and trials.

Andrew Powaleny, director of public affairs at PhRMA, told Focus: "This study’s narrow findings should not be used to make sweeping generalizations about the investment biopharmaceutical companies make in the development of new therapies. The study ignores the majority of costs related to the research and development (R&D) of a new medicine, ranging from extensive pre-clinical research, clinical trials, global coordination of clinical trials, development of manufacturing methods and multiple other aspects of development, suggesting a narrow view of the R&D process and risk companies face at the outset of an uncertain project." 

Article Updated on 9/26/18 with PhRMA comments.


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