SPARK leadership calls for a national clinical trial network before the next pandemic

SPARK leadership calls for a national clinical trial network before the next pandemic

Posted on June 3rd, 2022

In a letter to the editor published in Nature Medicine, SPARK at Stanford directors call for the establishment of a nationally-funded clinical trial network before the next pandemic surge.

Led by SPARK Director of Drug Innovation Rieko Yajima and SPARK Co-Director Kevin Grimes at Stanford University School of Medicine, the authors propose the creation of a federal agency to establish, coordinate and oversee a greatly expanded clinical trial infrastructure in the United States.

Dr. Yajima and Dr. Grimes, along with other SPARK leaders, have been heavily involved in COVID-19 therapeutic development over the last two years, and have directly observed the shortcomings in the U.S. clinical trial infrastructure. In fact, recent data from FDA showed only 5% of over 2,000 registered COVID-19 clinical trials were adequately designed to yield actionable results, the authors said. Hospitals and hospital systems in the U.S. are highly fragmented, and many lack resources to conduct clinical trials.

Instead, an agency reporting directly to the White House could integrate such fragmented medical facilities into a clinical trial network at the ready “to implement simplified, adaptive master clinical platform studies that can be conducted seamlessly in a pandemic surge.”

The authors added, “A coordinated national clinical trial network would increase efficiency, cost effectiveness and enrollment of diverse populations, while avoiding duplication of efforts.”

Dr. Grimes said, “To identify effective drug treatments early in a pandemic, we need an efficient national clinical trial infrastructure coordinating streamlined multi-arm studies that can be easily implemented in healthcare facilities that are overwhelmed by the influx of sick patients. For a relatively modest investment, the federal government could implement such a system. Between pandemics, this clinical trial system could be used for real-world studies leading to the approval of new therapeutics. Failure to act now will cost lives in the future.”

The correspondence’s other authors are Alexander More at Long Island University and Harvard University, Cynthia Garvan at University of Florida, and Corina Harper at Alexion Pharmaceuticals.