Keep the kids in mind when conducting clinical trials, say Clinigene

By Natalie Morrison

- Last updated on GMT

Related tags Clinical trials Recruitment Informed consent

Keep the kids in mind when conducting clinical trials, say Clinigene
Clinigene has called for more companies to consider paediatric applications of drugs from the beginning of their clinical trials.

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.

Related news

Show more

Related products

show more

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Related suppliers

Follow us


View more