Tag Archive: adaptive trials

Jan 17

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

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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Sep 28

Future of Clinical Trials – Conference Review

On September 15-17, I attended the Future of Clinical Trials conference produced by Leo Intelligence. The conference consisted of professionals from many aspects of clinical drug development. The first two talks set the stage for the rest of the conference and detailed the political and industry collaboration trends currently occurring. As political pressures are making drug …

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Sep 15

Future of Clinical Trials Conference 2010

The Future of Clinical Trials conference will be held in San Francisco, CA from 15-17 September 2010.  The focus of this year’s conference is, “Exploring Efficiencies and Strategies for Smarter Clinical Trials.”  The three day conference has an impressive list of speakers lined up, and promises to: Enlighten you to emerging breakthroughs in clinical trial …

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Aug 27

Five Keys to Successful Adaptive Trials

Running adaptive trials is not easy. However, in a world of skyrocketing drug development costs, these trials are set to become essential tools in any drugmaker’s repertoire, especially early in clinical development. A poorly done adaptive trial can not only result in trial failure (i.e. failure of the study to produce useful information about the …

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Aug 16

Joint Statistical Meetings 2010 Retrospective: A CRO Statistician's Perspective

Image via Wikipedia The Joint Statistical Meetings is often a good place to learn about emerging issues in the analysis of clinical trials (and all of the other fields that statistics touches, as a matter of fact). Here are just a few of the topics that stood out in my mind: Adaptive trials: of course, adaptive …

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Aug 16

Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective

Image via Wikipedia The Joint Statistical Meetings is often a good place to learn about emerging issues in the analysis of clinical trials (and all of the other fields that statistics touches, as a matter of fact). Here are just a few of the topics that stood out in my mind: Adaptive trials: of course, adaptive …

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Jun 23

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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May 10

Analysis of FDA Guidance on Adaptive Designs

In February 2010, the FDA published a draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics (“the guidance”). This highly anticipated guidance has come out in draft form 4 years after then FDA deputy commissioner Dr. Scott Gottlieb’s famous keynote speech on the topic accelerated interest on the topic. In the intervening years, …

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