FDA May Allow New 'Adaptive' Drug Trials

Includes: BMY, LLY, MRK, NVS, PFE, WYE
by: Mick Weinstein

Excerpt from our One Page Annotated Wall Street Journal Summary (get it e-mailed to you every morning by signing up here):

FDA Signals It's Open To Drug Trials That Shift Midcourse

  • Summary: The large drugmakers have begun using 'adaptive trials' that allow them to route larger groups of patients to more promising treatments in the middle of trials, and to drop treatments that seem ineffective in early testing. The FDA has begun to show some openness to accepting these new types of trials in its assessment and approval process -- the agency will today announce plans to develop official regulatory guidelines for the adaptive trials. Among the concerns: sponsors, doctors or patients may (consciously or not) become biased in their orientation to the drugs being tested, skewing the results, and preliminary results may leak through to investors.
  • Comment on related stocks/ETFs: Clearly a positive for the major pharm companies, among them Eli Lilly (NYSE:LLY), Wyeth (WYE), Bristol-Myers Squibb Co. (NYSE:BMY), Novartis AG ADS (NYSE:NVS), Merck (NYSE:MRK) and Pfizer (NYSE:PFE). As always, it's an interesting debate where consumer safety, effective treatment and big corporate payoffs meet.