Pharmacometrics tools of the trade: 4 factors to consider

Posted by Cytel

Nov 1, 2016 10:02:00 AM


Unlike statistics which has been around in some form for hundreds of years, pharmacometrics is, by comparison, a relatively new discipline and only entered the clinical development world in the last 30 years. Situated at the intersection of mathematical modeling, simulation, and big data, pharmacometrics leverages the best practices of translational research to generate clinical development strategy.

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Topics: pharmacometrics, Biomarkers, adaptive trials, pharmacology, PK/PD


Quantitative Pharmacology & Pharmacometrics for Biomarker Driven Clinical Strategy

Posted by Esha Senchaudhuri

Nov 3, 2015 6:14:50 PM

QPP (sometimes called QP2) remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD , statistical modeling and the modeling of go-no-go decision rules.

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Topics: Simulation & Biomarkers, pharmacometrics, Biomarkers


2 Methods for Evaluating Biomarker Subpopulations in (Adaptive Enrichment) Time to Event Trials

Posted by Cytel

Oct 5, 2015 4:14:58 PM

One consideration every sponsor of a biomarker-stratified confirmatory trial must take into account, is whether to evaluate the biomarker subpopulation (S) against the rest of the population (S') or against the full population (F).

Mathematically, one would think this makes very little difference as F is partitioned into S and S'. If the null hypothesis is rejected for both S and S' then clearly it is rejected for F too. Similarly, if it is rejected for S and not for S' then the therapy is effective for the biomarker subpopulation, and ineffective for the rest of the population.

As it turns out, whether or not a given biomarker is indeed a predictive biomarker should affect the choice of statistical methodology in time-to-event trials.

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Topics: Cyrus Mehta, Enrichment, Simulation & Biomarkers, time-to-even trials, Biomarkers


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 Phase 3 dose selection.

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


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