PhRMA Statement on JAMA Clinical Trials Study
WASHINGTON, D.C. (September 26, 2018) – Pharmaceutical Research and Manufacturers of America (PhRMA) spokesperson Andrew Powaleny issued the following statement in response to a JAMA Internal Medicine study on the cost of clinical trials:
“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.
“More fundamentally, the study excludes the significant cost associated with unsuccessful drug candidates and trials. Developing innovative new medicines is a long and complex process fraught with more setbacks than successes. Less than 12 percent of medicines entering a phase one clinical trial will ultimately be approved for use by patients. Setbacks are an inevitable part of the R&D process, and they must be factored into the cost of discovering new medicines.
“America’s biopharmaceutical companies are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. In 2017 alone, PhRMA members 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.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $900 billion in the search for new treatments and cures, including an estimated $79.6 billion in 2018 alone.