Clinical trials are more difficult to conduct in children, but they are even more necessary than in adultstheir scarcity is an ethical scandal. Mathematical models can be built that can describe both the disease process and the mechanism of action of drugs. These models can then be used to simulate the outcome of clinical trials. Inspection of the simulated results then facilitates optimisation of the trial design and proposed methods of analysis. Validation is a crucial issue for the good practice of modelling and simulation. The participants of Round Table No. 6 recommend: (i) that modelling be systematically employed; (ii) that all the required professional personnel be involved, at all phases; (iii) that all data needed are made accessible; (iv) that clinicians be trained; (v) that specialists develop training tool kits; and (vi) that universities provide appropriate training. Keywords: modelling, simulation, clinical trials, paediatric medicine Modelling and simulation (M&S) is a methodology that can be used to describe, predict and optimise the results of as yet unconducted clinical trials during all stages of drug development. The organising committee of the Giens Round Tables felt that more consideration could be given by clinical pharmacology to this topic. In 2003, a Round Table was organised where the fundamentals of M&S were reviewed. In 2004, it was discussed as to how M&S could successfully be applied in paediatrics. This document summarises the Round Table discussion "Modelling and Clinical Trials in Paediatrics" held during the Giens 2004 meeting. During the 3-day discussion, the regulatory, industrial and practitioner views on the need for, but also the difficulty of, performing clinical trials in the paediatric population were presented. Furthermore, the modelling approach in paediatrics was reviewed and illustrated with practical examples, and the modelbased clinical trial simulation technique for design optimisation was presented. Finally, aspects of the validation, guidelines, education and working environment relating to M&S were debated.
PHARMACOLOGIE CLINIQUE
Regulatory, Industrial and Practitioner Views on the Need for Clinical Trials in PaediatricsNowadays, care in paediatrics is still characterised by the paucity of clinical pharmacology and drug development resources: data are scarce and globally lacking with regard to the fundamentals of clinical pharmacology, including pharmacokinetics, pharmacodynamics and safety. Many of the available drug formulations are inappropriate for use in paediatrics.The idea that children are reduced models of adults is appealing; this follows the principle of parsimony and simplicity, which is fundamental to good practice in modelling. However, this idea is completely wrong and misleading: (i) absorption, distribution, metabolism and excretion are different in children and, moreover, are evolving throughout the maturation of the child, with dramatic changes occurring at different points in time; (ii) diseases in children are often different in n...
