NIH clinical development spend of drugs compared to industry

New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. This was ~10 percent of reported industry spending. The article, written researchers at Bentley University, is the first to broadly assess NIH’s contribution to clinical development of new drugs and compare the scale of NIH spending relative to reported spending by industry.

Supporting clinical development in the pharmaceutical industry

NIH funding for clinical trials represented <3.5 percent of total NIH spending for basic or applied research related to these products.

In total, $247 billion NIH funding contributing to more than 2.5 million publications describing basic or applied research related to 386 of 387 drugs approved 2010-2019 with $8.1 billion (3.3 percent) related to phased clinical development, the study identified.

This funding contributed to >12 thousand publications describing phased clinical trials involving 240 of 387 (62 percent) approved drugs. Average NIH spending was $33.8 million per approved drug. This was significantly lower than reported industry spending.

Overall, NIH clinical development spending represented ~25 percent of Phase I costs, ~22 percent of Phase II costs, and ~four percent of Phase III costs. This was largely limited to programmes designed to advance clinical and translational science in general by supporting centres, core capabilities, and training.

More than 90 percent of NIH funding came through approaches designed to advance translational science practice or support programmes or centres that provide clinical research capabilities, patient networks or consortia, or training in clinical, translational, or regulatory science (including Clinical Translational Science Awards).

NIH’s investment in the pharmaceutical industry

“This analysis confirms previous studies showing that the NIH makes substantive investments in the basic and applied science underlying new drugs, but also demonstrates that the NIH makes only limited contributions to development” stated Fred Ledley, Director of the Center for Integration of Science and Industry, and the study’s senior author. “This is consistent with policies that position the public sector as an early investor in pharmaceutical innovations that are subsequently developed and commercialised by the pharmaceutical industry.”

This research on clinical development in the pharmaceutical industry was supported by funding from the National Pharmaceutical Council and the National Biomedical Research Foundation.

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