Category Archives: Clinical Trials

Adaptive Clinical Trials Workshop – An Opportunity Gone South

Back in July when Dr. Scott Gottlieb made a speech before the American Medical Association and made a lengthy reference to a November workshop in which FDA would participate regarding adaptive clinical trials, there was a great deal of anticipation … Continue reading

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Antibiotics and Clinical Trials

What happens when the FDA decides on new policies during the course of a clinical trial?  Last week, Replidyne and Forest Laboratories reported that the FDA issued a non-approvable letter for Faropenem, an antibiotic.  The FDA wanted further clinical studies … Continue reading

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Is the Adaptive Clinical Trials Workshop a Private Affair?

One might ask oneself why, if an important conference in which there is a high level of interest is just a few weeks away, have details not been announced.  The answer may be that most of us assumed that the … Continue reading

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Waiting for Word on the Adaptive Clinical Trials Workshop

Back in July, FDA’s Dr. Scott Gottlieb gave a speech in which he talked about an upcoming conference on clinical trial design to be held in November.  Word has it that the conference is going to be on the 13th … Continue reading

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Adaptive Clinical Trials – Just Do It!

Some time ago, it became apparent that the FDA was going to participate in a conference on adaptive clinical trials.  Dr. Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs, Food and Drug Administration — gave a speech on … Continue reading

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