It’s Time to Bridge the Gap Between Pharmacometrics and Biostats

Posted by Esha Senchaudhuri

Oct 1, 2015 5:22:00 PM

This week marks the sixth annual American Conference on Pharmacometrics, held this year in Crystal City, VA. Situated at the intersection of mathematical modeling, simulation and big data, the field of pharmacometrics is delivering on its promise to revolutionize clinical research and by extension clinical development.

No wonder then that biostatisticians are now fully engaged with the enterprise.  

Pharmacometric models capture the complex interaction between biology, pharmacology, disease and physiology by developing models that quantify interactions between patients and xenobiotics [1]. Pharmacometric techniques allow efforts in model-based drug development to draw on data across several fields, thereby leveraging the best practices of translational research to generate clinical development strategy.  

This year’s meeting features a full day pre-conference on how the two disciplines of pharmacometrics and biostatistics best interact with each other.

Cytel Pharmacometrician Cecilia Fosser will also be organizing a panel on the uses of pharmacometric methods to assess categorical safety data in earlier phases of drug development.

One of the panel talks will be given on the uses of the “adaptive switch” clinical trial designs. The use of pharmacometric techniques in adaptive clinical trials is still under-explored and this talk aims, at least in part, to start building more bridges between these two thriving subsectors of drug development. 

Developed by Cytel co-founder Cyrus Mehta and Cytel statistician Lingyun Liu, the adaptive switch is a clinical trial design in which a trial begins as a noninferiority trial and switches to a superiority trial depending on early results. The switch occurs while allowing the possibility for a sample size re-estimation after the switch.

Cecilia Fosser's panel will also feature research by Cytel’s Ananda Gubbi.

Related Items of Interest

[1] Barrett, et al., 'Pharmacometrics: A Multidisciplinary Field to Facilitate Critical Thinking in Drug Development and Translational Research SettingsJournal of Clinical Pharmacology 2008(48): 632 - 649. 

[2] Why You Should Not Power for Superiority Upfront: Promising Zone Clinical Trials with "Adaptive Switch"

[3] Sixth Annuel American Conference of Pharmacometrics (Event Website) 

Topics: Adaptive Clinical Trials, Statistical Innovations in Clinical Development, pharmacometrics

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