Thomas Jefferson University-based Research: Clinical Trials Under Siege in America

Sep 10, 2019 | Clinical Trial Crisis, Clinical Trials, Investigators

Clinical testing research, Pharmacy and Medicine concept on screen.

As reported in the Annals of Internal Medicine, clinical research in America faces profound challenges. From a declining number of clinical trials performed to shrinking numbers of participants enrolled to dwindling amounts of willing investigators (and the “one and done” problem) the overall apparatus is in trouble. The United States has the highest proportion of clinical trial sites worldwide (43%) but the annual growth rate is negative between 2006 to 2012.

What are the Factors Involved in this Decline?

The net result of the siege is that the United States doesn’t promote clinical research like it used to. Economic drivers range from the cost of performing clinical studies incentivize sponsors to seek out other countries such as China. Reductions in federal funding make the life of investigators turn to clinical practice where they can earn a living a repay medical school debt. A bureaucratic and regulatory labyrinth maze buries clinical investigator sites with onerous operating policies, procedures, and mountains of paperwork—fear of investigator liability follow and the cons increasingly outweigh the pros of engaging in clinical research. Moreover, transforming reimbursement models, driven by value-based and performance models, combined with suites of software to navigate incentivize physicians to emphasize clinical practice time. Finally, the aging and dwindling numbers of investigators result from these macrotrends and threaten the ability of the United States to remain the global leader in clinical research. 

Lead Researcher

David J. Whellan, MD, MHS, Jefferson Clinical Research Institution, Thomas Jefferson University

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