Bioregnum, FDA, Insiders

The 2-trial hurdle for drug approvals is steadily losing ground. Are we devaluing the industry’s R&D gold standard?

Over the weekend I had a lengthy discussion with Acorda CEO and former BIO chairman Ron Cohen on Twitter about p values and FDA standards that I’d like to share with you.

It related to a story we ran a few days ago citing Stanford’s John P A Ioannidis on the likelihood of false positives when you set a standard for success at p<0.05. Ioannidis and several other statistical experts have voiced the need of raising that statistical bar — lowering the cutoff — to prevent stamping some failures as a success.

Cohen, who felt that the FDA’s “typical” standard requirement of two “adequate, well controlled” studies made it virtually impossible to get an approval based on a statistically shaky readout, wasn’t accepting any anecdotal analysis from me. He wanted hard numbers. So I got some. The FDA is quite explicit about the data used to approve a drug. It’s easy to check how many drugs were approved last year using the two-trial standard.

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