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# Coordinated National Trial Infrastructure Needed: Gottlieb
- URL: https://www.fdaweb.com/coordinated-national-trial-infrastructure-needed-gottlieb/
- Published: 2021-08-31T12:00:00.000Z
- Updated: 2026-09-14T17:12:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150050

Former FDA commissioner **Scott Gottlieb** says the U.S. needs a “coordinated national clinical trial infrastructure in the setting of a public health crisis.” Writing online in *JAMA Health Forum*, Gottlieb [says](https://jamanetwork.com/journals/jama-health-forum/fullarticle/2783677?utm%5Fcontent=buffer53083&utm%5Fmedium=social&utm%5Fsource=twitter) the need for a coordinated infrastructure was demonstrated during the Covid-19 pandemic when U.S. investigators conducted hundreds of scattered trials that were often poorly designed and would never yield practical evidence.

“At the same time,” he says, “we were not able to establish early enough when treatments that were in widespread use were not providing patients with any benefit and were perhaps causing harm.”

Gottlieb writes that FDA and the National Institutes of Health (NIH) should be empowered to steer patients into trials that are more likely to yield actionable evidence that can inform clinical practice and improve outcomes. “That also means,” he says, “that we need to rely more on practical trial designs such as the approach used in \[Britain’s\] RECOVERY (Randomized Evaluation of Covid-19 Therapy) trial. FDA and the NIH should have the authority to prioritize among therapies those that have the most promise and accelerate enrollment of studies to evaluate these high-priority medicines.”

Gottlieb says the U.S. response to Covid-19 suffered from the inability to quickly enroll and complete rigorous studies that could provide more definitive evidence around not only which treatments worked to reduce the symptoms and severity of Covid-19, but also decisively establish which drugs were not effective. “In the absence of conclusive information,” he says, “findings from speculative studies, observational data, and anecdotes were able to fill the ensuing information vacuum. A devotion was able to form around the hoped-for benefits of drugs like hydroxychloroquine and, once established, that belief was impossible to pierce, even when more decisive evidence eventually emerged, much later in the crisis.”