Keep the kids in mind when conducting clinical trials, say Clinigene
Speaking at this year’s DIA Euromeeting in Denmark, the firm’s director regulatory intelligence and policy Anu Tummavuori said that with more than 70 per cent of drugs on the market never tested in children in their own age classes there is a huge gap in the market.
“Paediatrics should be a part of overall product development. We should be thinking of them from planning the first clinical trials,” Tummavuori urged firms.
However she warned that companies after a slice of the potentially lucrative industry should be aware of the minefield that is clinical trials in children before submitting a PIP (paediatric investigation plan) to the regulators.
Of numerous problems, she ranked formulation high on the scale. “Finding the right formulation can be very challenging for companies,” she said. “Very often you can’t give children the original formula, for instance a child cannot swallow a big capsule”
She also stressed the importance of a “one-size fits-all” formulation for different subsets. “Taste, for example, differs geographically,” she added. “I am from Switzerland, where salted liquorice is popular but I’m sure it is not in other areas.”
Tummavuori suggested that firms should consider formulation for children early in development, however remarked that cost-wise, it is not always realistic to develop it in parallel with adult versions.
A different design
Listing more hurdles, Tummavuori went on to talk about Clinigene’s experience in paediatric trials saying more often than not they are extremely lengthy.
She stressed: “You must leave plenty of time for the recruitment process. It’s very easy to underestimate the time needed, especially rarer inclusions. And you must be aware that you are pumping money into a trial that may recruit just one patient, or worse still, none at all.
“Be flexible with time because you have to be aware the subject could be missing school or the parent may have to take time off work.”
More than in adult trials, paediatrics is about building relationships she added. “Parent consent is important, so building a good relationship with the parent is vital.”
But despite the list of potential issues, Tummavuori said that for companies willing to try and run the obstacle course, an unsaturated industry lies ahead.
