Cytel Case Studies Series #1: Using Simulation for Accelerated Early Phase Drug Development

Posted by Cytel

Sep 4, 2015 10:30:00 AM

Our Client's Challenge:

Can knowledge of the relationship between biomarkers and clinical endpoints help us to optimize an early development program and improve the probability of selecting the right dose in Phase 3?

Our client approached us hoping to expedite dose-finding with biomarkers in Phase 1b, and to design an optimal Phase 2b clinical endpoint trial to maximize probability of correct...

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Topics: Cytel Consulting, Early Phase Trials, Clinical Development Strategy, Proof-of-Concept, Case Study, Biomarkers, Simulations


Mitigate Phase 3 Clinical Trial Risk by Optimizing Phase 2 Data

Posted by Esha Senchaudhuri

Aug 10, 2015 2:32:34 PM

When approaching a Phase 3 clinical trial, the need to ‘de-risk’ the massive investment often leads sponsors on a quest for the perfect risk mitigating adaptation. While a strategically planned clinical trial design can be an important step in giving a new medicine its best possible chance of success, there are a number of other ways that a trial sponsor can minimize study risk.

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Topics: Dose-Finding, Early Phase Trials, Proof-of-Concept, Clinical Data, MCP-Mod


Adaptive Clinical Trial Strategies for the Limited Early Phase Budget

Posted by Esha Senchaudhuri

Jan 22, 2015 9:00:00 AM

The Journal of the American Medical Association recently published an article entitled ‘The Anatomy of Medical Research: US and International Comparisons.’ The stated objective of the study was to “quantify total public and private investment and personnel (economic inputs) and to evaluate resulting patents, publications, drug and device approvals, and value created (economic outputs)“ [1]

...

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Topics: Dose-Finding, Early Phase Trials, Proof-of-Concept, Case Study


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