A Year in the Life of a Software Trainer

Posted by Cytel

Mar 27, 2018 11:20:00 AM

 East is the industry standard platform for clinical trial design, simulation, and monitoring, improving scientific productivity during the critical planning stages of clinical development.  In this blog, our Hrishikesh Kulkarni takes us on a tour of his life as a Cytel software trainer and answers some frequently asked questions about how East training sessions work in practice.

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Topics: Trial Design Software, EAST 6.4, Multi-Arm Multi-Stage Studies, East ESCALATE


Case Study: BLRM for Phase 1/2a Oncology Study

Posted by Cytel

Sep 2, 2016 10:30:00 AM

 

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Topics: biostatistics, adaptive trials, Dose-Escalation, EAST 6.4, East ESCALATE, BLRM, CRM, Oncology, Early Phase Trials, Eearly Development


An Introduction to BLRM

Posted by Cytel

Aug 31, 2016 1:11:57 PM

Traditional rule-based approaches to dose escalation such as 3+3 are widely used in early clinical development. They can be appealing due to the simplicity of execution. However, estimates produced may be highly variable and the targeting of true Maximum Tolerated Dose may be poor.  Bayesian dose escalation approaches in early phase trials can offer an effective alternative to determining the...

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Topics: biostatistics, adaptive trials, Dose-Escalation, EAST 6.4, East ESCALATE, BLRM, CRM


Adaptive Dose Finding Using Toxicity Probability Intervals

Posted by Esha Senchaudhuri

Oct 28, 2014 9:30:00 AM

Phase 1 oncology trials typically use either rule-based methods or model-based methods to determine the most acceptable level of dose toxicity with which to move forward in Phase 2. This level of toxicity, called the maximum tolerated dose (or the MTD), is the dose which best balances the medical benefits of a higher dose with the risk of toxicity which comes from subjecting a patient to that...

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Topics: Oncology, East 6.3, Access to Slides PDF, East ESCALATE, Adaptive Clinical Trials


The Rev Bayes Parties with Cytel at JSM 2014

Posted by Esha Senchaudhuri

Aug 8, 2014 9:00:00 AM

Photos leaked from JSM 2014 appear to show the Reverend Bayes partying with his entourage at the Cytel Cocktail Hour, held at Boston’s Seaport Hotel on August 4, 2014. Bayes is, of course, one of the stars of Cytel’s East 6.3, a modular software package driving drug development through high quality trial design and simulations. Bayes's contributions to the East ESCALATE and East PREDICT...

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Topics: East 6.3, Dose-Escalation, Bayesian Methods, Cytel Consulting, East PREDICT, East ESCALATE


5 Reasons to Invest in Bayesian Dose-Escalation Methods

Posted by Esha Senchaudhuri

May 8, 2014 7:54:00 AM

( Editor's note: This post has been refreshed in December 2016)

Model based algorithms for Phase I dose-escalation have been in existence for nearly thirty years. Despite guarantees of increased statistical power and greater accuracy, there remains a clear preference for rule based algorithms amongst clinicians. The explanation for this is as old as the models themselves.

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Topics: Oncology, Dose-Escalation, Bayesian Methods, EAST 6.4, East ESCALATE


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