IMI project c4c has pioneered an advice process involving diverse experts including patients to aid drug developers when designing paediatric clinical trials.

Up until relatively recently, children were treated like “little adults” when they were sick. Medicines specifically made for children were almost unheard of, and instead children were prescribed medication at lower doses, accounting for their weight.

However, this doesn’t always work. Clinicians quickly learned – because sadly, children died – that newborns and young infants often require even less of a medicine than their weight would suggest, because their organs are immature. And for toddlers, it’s the reverse – their rapid metabolism means that toddlers may need a higher dose than you would otherwise expect, compared to an adult.

In 2007, the EU Paediatric Regulation was passed, which required appropriate testing of paediatric medicines through clinical trials in children. But developing drugs for children comes with its own suite of unique problems. A one-year-old might respond differently to a seven-year-old, so the pharmaceutical industry needs to run tests on a wide variety of age groups. Children are also constantly growing and their physiology changes rapidly in just a short number of years, so tests must be performed quickly.

The Innovative Medicines Initiative project conect4children (c4c) sought to tackle this problem by setting up a Europe-wide network to make clinical trials in children easier to conduct whilst also connecting clinicians, academia, methodology experts and parents to ensure high-quality clinical trials for children’s drugs.

A pilot expert advice process was developed under c4c, through which drug developers can easily access a wide array of important information directly from experts when designing clinical trials.