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Tag Archives: adaptive trials
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 … Continue reading
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 … Continue reading
Posted in Conferences and Meetings, Statistics
Tagged adaptive trials, Cato Research, clinical trials, conference, statistical analysis
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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 … Continue reading
Posted in Clinical Trials, Statistics
Tagged adaptive trials, clinical trials, CMC, interim analysis, randomization, statistical analysis
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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 … Continue reading
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In a recent post, John Johnson discussed the FDA’s draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics, particularly in the context of planning and designing a clinical trial.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) … Continue reading
Posted in Clinical Trials
Tagged adaptive design, adaptive trials, analytical testing, API, clinical supplies, clinical trials, drug product, FDA, guidance, labeling, manufacturing
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