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


Dual Agent Dose Escalation Designs

Posted by Cytel

Apr 22, 2016 9:30:00 AM

FDA draft guidance on “Co development of two or more unmarketed investigational drugs for use in combination”  notes that:

“Combination therapy is an important treatment modality in many disease settings, including cancer, cardio-vascular disease, and infectious diseases. Recent scientific advances have increased our understanding of the pathophysiological processes that underlie these and...

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Topics: Oncology, Phase 1, Early Phase Trials, Adaptive Clinical Trials, BLRM, Bayesian, PIPE


A Competitive Alternative to Model-Based Dose-finding

Posted by Cytel

Nov 19, 2015 4:00:00 PM

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Topics: Dose-Finding, BLRM


Takeda Pharmaceuticals' Ling Wang Talks Model-based Dose-finding Designs

Posted by Cytel

Nov 16, 2015 4:30:00 PM

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Topics: Dose-Finding, BLRM


Modern Early Phase Clinical Trial Design Primer

Posted by Cytel

Sep 1, 2015 4:01:39 PM

If you’re in the practice of conducting early phase clinical trials, you’ve probably heard that modern trial designs include a number of new methodologies. There’s CRM and BLRM, model-based methods versus rule-based methods, and a number of other developments that might affect your clinical strategy. Each of these methods affects operational, financial and regulatory objectives in unique ways.

As...

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Topics: Bayesian Methods, CRM, Early Phase Trials, Clinical Development Strategy, BLRM


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