Children must be included in more trials to drive paediatric development: experts

30-Sep-2012 - Last updated on 01-Oct-2012 at 12:21 GMT

Children are left out of clinical trials too often, say experts

Children are not included in enough clinical trials in the US, according to an FDA committee.

A report by Clinical Trials Transformation Initiative (CTTI) – a public-private partnership founded by the US Food and Drug Administration (FDA) and Duke University – looked at more than 60,000 research trials between 2005 and 2010 on the ClinicalTrials.gov registry.

And though children make up more than one quarter of the population in the US, the team found that just 5,000 of those trials enrolled patients under 18.

Lead researcher Sara Pasquali said by leaving younger populations out of trials, sponsors and vendors are stunting the development of better therapies, and warned that doctors are being left in the dark on how to treat using adult-tested medications.

Ethical issues when treating children – for instance the fact that the child is not a volunteer, and trials in younger children, who cannot accurately express their pain level – were flagged as key reasons companies give paediatric trials a wide birth.

Pasquali also said lack of practice standards are behind the problem, but added that standards will never be established if more trials in the young are not carried out.

"Many pediatric diseases are relatively rare, as opposed to something like adult coronary artery disease. As a result, it can take much more time to build a research infrastructure, often involving multiple hospitals, to enroll enough patients in a study," she said.

"But with fewer studies to guide therapeutic decisions, treatments and outcomes for young patients often vary widely from center to center."

Time for change

Pasquali added that with a lack of child-realted data for the “vast majority” of therapies used on under 18s, doctors lack the information to support their decisions about dosage and which medicines are appropriate in the right situations. She said: "Without that information, it really puts physicians and the children we're treating at a significant disadvantage."

However Pasquali and co are not the first in recent times to call for better representation for a “difficult” age group.

Clinigene’s director of regulatory intelligence and police Ana Tummavuori said there is a “huge gap” in the market with over 70 per cent of drugs never tested on children. She urged firms to consider more child-focused formulations as a priority.

There was also a call for more trials for the elderly when last month experts told Outsourcin-Pharma.com they are often left out for similar reasons such as ethics, and dosage difficulties.