Responding to a US Food and Drug Administration (FDA) committee’s recent call for more paediatric trials, the home visit services provider told us children could experience lasting “harm” from the distress of research.
The UK-based firm agreed that more studies for the age group must be carried out if medicine for children is to advance, however said the “vulnerability” of the age group is off-putting for companies.
Speaking to Outsourcing-Pharma.com, Debbie Easlea ResearchNurse.co team manager and specialist in paediatrics said: “Many children are vulnerable, easily bewildered and distressed and unable to express their needs or defend their interests. Potentially with many decades of life ahead of them they are likely to experience in growth and developments the most lasting benefits or harm from research.
“It is this very vulnerability that often discourages pharmaceutical companies and research institutions from undertaking research projects in children.”
Time for change
However, though Easlea said while firms should be wary, they are often overly cautious.
“At times this may amount to overprotection leaving considerable gaps in our knowledge of pharmacokinetics and pharmacodynamics in the paediatric age group and it prevents us from achieving optimal drug treatments in infants and children,” she said.
She added that traditional views on treating children in terms of dosage and formulation – in which they are medicated as “small adults” – must change if the industry is to run more tests specifically for kids.
"We still continue to dose paediatrics using body weight as a guide as in many circumstances we have no data to analyse the absorption, distribution, metabolism and excretion (ADME) that a drug undergoes when given to babies and children,” she said.
“It may be under or over treating the child whose absorption and excretion rate may be higher or lower, due to their metabolic rate or other factors.”
Easlea also told us public perception of clinical trials need to change, especially for paediatric trials where parents are unwilling to allow their child to be a “guinea pig”.
She said: “There is a need to provide an adequate explanation, as would be done during the informed consent process, when discussing clinical trial involvement with potential subjects or in this instance their parents or guardians.”
Including home visit nurses in trials, she said, is one solution to the problem.
“Siblings and other family members can interact with study staff and be involved in the process,” she told us.