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Gottlieb Redefines What is Meant by “Gold Standard” at His Senate Hearing

Gottlieb Redefines What is Meant by “Gold Standard” at His Senate Hearing | Pharma Industry Regulation |

When Dr. Scott Gottlieb pledged at his confirmation hearing to uphold a “gold standard of safety and efficacy” at the Food and Drug Administration, he raised an important question:


What exactly does he mean by that?


Traditionally, “gold standard” refers to robust, randomized controlled clinical trials. But there’s enormous pressure on the FDA — from pharma companies and Congress, for starters — to accept other kinds of evidence, perhaps even patient anecdotes, to determine whether experimental drugs work. And President Trump is promising to speed drug approvals.


So when Gottlieb said: “I think there are ways to modernize clinical studies without sacrificing the gold standard,” he raised red flags.


“I don’t think he was using the phase ‘gold standard’ in the way that most of us who think about the agency for a living understand it,” said Rachel Sachs, an associate professor of law at Washington University in St. Louis.


So what exactly is Gottlieb’s idea of “gold standard?” Find out more here.


[While Deputy Commissioner for Medical and Scientific Affairs at FDA, Gottlieb presented his views of “adaptive clinical trial design” as a “potentially better alternative” to the “traditional, highly empiric statistical approach” that is the hallmark of the gold standard at a 2006 Conference on Adaptive Trial Design. ]


  • Further Reading:
  • “’We Want the Gold’ Standard of FDA Approval, Says PhRMA CEO Ubl”;
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