by Peter Huber
May 17, 2013
The FDA’s current protocols treat patient selection as a problem that the drug company must solve before the clinical trial begins or, to a limited extent, when it is in its very early phases. At best, this means that the drug is prescribed to many patients whom it fails to help or even harms during the trials, and to still more of the wrong patients after it’s licensed, until enough post-licensing data accumulates and reveals how to prescribe the drug more precisely. At worst, drugs that some patients desperately need don’t get licensed because the trials include too many of the wrong patients.