Examining the truth behind clinical trial costs

Notably absent from the study findings were the R&D costs associated with the nearly 90 percent of medicines that never attain FDA approval.

John Corea
John CoreaOctober 2, 2018

Examining the truth behind clinical trial costs.

Last week, a study appearing in the Journal of the American Medical Association (JAMA) Internal Medicine, evaluated the costs specifically associated with successful clinical trials for novel therapeutic medicines. The narrow findings of this study have been misconstrued to suggest that the research and development (R&D) investments needed to bring a new treatment to patients may not be as large as we thought. 

Notably absent from the study findings were the R&D costs associated with the nearly 90 percent of medicines that never attain U.S. Food and Drug Administration approval. These setbacks, an inevitable part of the R&D process, are a major reason companies spend an average of $2.6 billion for every medicine they bring to market, according to the Tufts Center for the Study of Drug Development.

In its limited purview, the study further only examined what the authors termed, “pivotal efficacy trials.” Left out were the many other important elements of the R&D process, ranging from extensive pre-clinical research and many clinical trials to global research coordination and the development of manufacturing methods. As a result, the cost picture that emerges from the JAMA Internal Medicine study represents only a fraction of the entire endeavor.

While drug development is a complex process fraught with more setbacks than successes, the biopharmaceutical industry is committed to finding new medicines and in 2017, PhRMA member companies alone invested $71.4 billion in that effort and the biopharmaceutical industry accounts for the single largest share of all self-funded R&D, representing one out of every six dollars spent on domestic R&D by U.S. businesses. Biopharmaceutical companies are further working to make the process more efficient by leveraging the latest drug development tools and clinical trial approaches to streamline the R&D process. 

It is through all these efforts that America’s biopharmaceutical companies will continue to discover and develop medicines that enable patients to live longer, healthier, and more productive lives.

To learn the full story of the biopharmaceutical research and development process, click here.

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