Interview: Promoting precision medicine using data science 

Posted by Cytel

Jan 23, 2018 10:36:00 AM

 News Medical interviewed Dr. Rajat Mukherjee, Statistician, and Director of Data Science at Cytel to investigate the potential of data science in clinical development.

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Topics: Precision Medicine, Simulation & Biomarkers, big data, data science, biomedical signals

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

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