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https://www.cytel.com/blog/opportunities-of-fdas-complex-innovative-trial-design-pilot-meeting-program
September 7, 2018
On August 29th 2018, the FDA announced (1) that it would be establishing a Complex Innovative Trial Design (CID)..
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https://www.cytel.com/blog/22-case-studies-mitigating-phase-3-risks
April 11, 2017
In a January 2017 paper (1), the FDA reviewed 22 case studies where promising Phase 2 trials did not result in..
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https://www.cytel.com/blog/flexible-approaches-biosimilar-development
March 10, 2017
At the recent Biosimilars Summit in Philadelphia, Cytel's Pantelis Vlachos presented on statistical challenges and..
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https://www.cytel.com/blog/bayesian-decision-making-in-phase-3-oncology
March 2, 2017
We continue our case study series with this example of a Phase 3 design that uses Bayesian decision making combined..
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https://www.cytel.com/blog/create-ssr-design-east-insights
November 9, 2016
Adaptive sample size re-estimation designs are an important part of the statistician's toolkit. In this first in a..
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https://www.cytel.com/blog/learning-from-less-well-understood-adaptive-designs
September 29, 2016
A paper "Best practices case studies for 'less well-understood' Adaptive designs", has been published by the DIA..
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https://www.cytel.com/blog/adaptive-designs-in-practice-interview-munyadimairo
April 28, 2016
Adaptive Designs in Practice: Interview with NIHR Research Fellow Munya Dimairo NIHR and University of Sheffield..
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https://www.cytel.com/blog/adaptive-sample-size-re-estimation-efficiency
March 3, 2016
'The aim of a discussion should not be victory but progress.' This principle, expressed by the French essayist Joseph..
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