Pharma Blog Watch

Adaptive Trial Design (DrugWonks)
In his entry, blogger Peter Pitts comments on the FDA's recent "championing" of adaptive clinical trials in light of Deputy Commissioner Scott Gottlieb's speech on the subject Monday.

"'Traditional' clinical trials that demonstrate a 40 percent efficacy rate without even attempting to isolate which 40 percent are expensive in financial terms and only marginally helpful in helping physicians best treat their patients," he writes. "It also plays into the hands of the Evangelists of Evidence-based Medicine and the Votaries of Me-Tooism. We must think about clinical trials in new ways. It's a crucial aspect of the Critical Path."

Novartis' Galvus Delay (Pharma's Cutting Edge)
In his blog, Fred Cohen discusses the delay of the FDA's review of Novartis' diabetes drug Galvus. "What interests me about the story is the reasoning behind Novartis' move. Apparently, in one or more monkey tox studies there was evidence of 'skin lesions' that were of some concern. Presumably, Novartis was trying to head off a dreaded approvable decision or maybe a nasty label warning with the additional clinical-data submission."

"It's hard to deduce too much from this limited information, but what I can tell you is that monkey studies aren't run to look for skin toxicity specifically, so if a skin finding was made in monkeys, it was made during the course of a general toxicology or safety pharmacology study (more likely the former)," he writes. "What is quite unusual about this case, though, is that drug-related skin reactions occurring after systemic administration, immune-mediated or otherwise, are not usually not picked up during preclinical testing at all. They are usually first reported during clinical trials as human adverse reactions, sometimes not seen until after approval."