Kerfuffle! (pt 1)

Chapter 1 of 3.

A kerfuffle is the polite term for a cascading series of errors that can be initiated by a seemingly innocuous event that then leads to other errors that seem to gain in severity and impact. Kerfuffles can appear in any line of work or play that involves a linked series of tasks with downstream implications. In fact, the modeling and simulation activities performed to support model-based drug development have the potential to produce a catalogue of kerfuffles that can culminate in the failure to deliver modeling and simulation results when they are needed for decision-making. Kerfuffles often have their origins in inadvertent oversights committed early in the study design and data collection process or in the commonplace shortcuts taken to deliver preliminary (“quick-and-dirty”) results for internal use.

Kerfuffles are important to pharmacometricians for three reasons. First, they waste valuable resources while generating little knowledge of real value. Second, they put pharmacometricians in the uncomfortable role of being an apologist in having to explain why modeling, under these circumstances, is not feasible and that “even allocating more money or additional resources won’t fix the immediate problem.” Third, they can pit industry against regulatory scientists because the lack of objective standards for model acceptability can reduce discussions to a subjective basis. The process of eradicating or minimizing the impact of these pharmacometric kerfuffles begins with the recognition that the errors that contribute to the kerfuffle not just an unpleasant aspect of the job that pharmacometricians must learn to live with in the conscientious execution of their work.

Are you hooked? Don’t worry, there’s more where that came from. Click here for the next installment.