Tag Archive: adaptive design

Jan 17 2013

Enrichment Strategies for Clinical Trials

On 14 December 2012, the FDA released the guidance Enrichment Strategies for Clinical Trials to Support Approval for Human Drugs and Biological Products.  The guidance is intended to provide strategies for drug developers to enrich enrollment for responder subjects in both early and pivotal clinical trials.  Often, simply enrolling subjects that have the disease that …

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Feb 23 2012

The CED Life Science Conference and Biotech’s Yellow Brick Road

The 21st annual CED Life Science Conference achieved its mission of cementing the Research Triangle Park as a hotbed for innovation and opportunity in biotech.  The 2012 CED LSC showcased local leaders like Victor Dzau, President and CEO of Duke University Health Systems, and former four-term North Carolina governor James B. Hunt, as well as …

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Jun 23 2010

Adaptive Designs and Clinical Supplies

In a recent post, John Johnson discussed the FDA’s draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics, particularly in the context of planning and designing a clinical trial.  My perspective concerns challenges related to clinical supplies (CS) presented by adaptive trial designs. FDA defines an adaptive design clinical study as “a study …

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