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Stock Watch: Lilly’s Emgality Trod A Well-Beaten Path To Clinical Failure

Beware The Clinical Trial Comparator Arm

 
• By Andy Smith

The outcome of any clinical study is uncertain but the choice of active comparator and sometimes even the placebo arm can magnify unpredictability. Emgality’s recent head-to-head failure in migraine is just the latest in a long list of casualties.

Stock Watch Image, Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

When I moved to the commercial side of a big pharmaceutical company, one of the first things I did was to read through all the promotional copy and labels for my product, along with the old papers, posters and even the advisory board minutes.

In one of these latter documents a key opinion leader commented on how well the placebo arms of the Phase III studies had performed against the active arms of what became the leading topical branded antibiotic product – Bactroban (mupirocin) for the treatment of skin infections. The advisory board then discussed the well recognized role of the formulation’s main excipient (polyethylene glycol) in promoting wound healing as the reason for the placebo’s performance

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