Paediatric models in motion: requirements for model-based decision support at the bedside.

Optimal paediatric pharmacotherapy is reliant on a detailed understanding of the individual patient including their developmental status and disease state as well as the pharmaceutical agents he/she is receiving for treatment or management of side effects. Our appreciation for size and maturation effects on the pharmacokinetic/pharmacodynamic (PK/PD) phenomenon has improved to the point that we can develop predictive models that permit us to individualize therapy, especially in the situation where we are monitoring drug effects or therapeutic concentrations. The growth of efforts to guide paediatric pharmacotherapy via model-based decision support necessitates a coordinated and systematic approach to ensuring reliable and robust output to caregivers that represents the current standard of care and adheres to governance imposed by the host institution or coalition responsible. Model-based systems which guide caregivers on dosing paediatric patients in a more comprehensive manner are in development at several institutions. Care must be taken that these systems provide robust guidance with the current best practice. These systems must evolve as new information becomes available and ultimately are best constructed from diverse data representing global input on demographics, ethnic / racial diversity, diet and other lifestyle factors. Multidisciplinary involvement at the project team level is key to the ultimate clinical valuation. Likewise, early engagement of clinical champions is also critical for the success of model-based tools. Adherence to regulatory requirements as well as best practices with respect to software development and testing are essential if these tools are to be used as part of the routine standard of care.