Module232025

07/05/2025

Origin(s) of the age barrier

• Desire to protect the “vulnerable” • The National Institutes of Health defines “vulnerable” as:

children, pregnant women, prisoners, the decisionally-impaired, racial or ethnic minorities, those who are very sick or terminally ill, institutionalized, handicapped, mentally disabled, economically disadvantaged, traumatized/comatose, educationally disadvantaged, those who will not benefit from the research, those for whom research is combined with care, unemployed, students/ employees, nomads, people in emergency rooms, displaced persons, members of the military, elderly and healthy volunteers http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3601707

• Uncertainty regarding the assent/consent/dissent requirements • Potential adverse publicity should AEs occur • Rigid regulatory classification regarding drugs approved for pediatric use

The Organisation for Professionals in Regulatory Affairs

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Criticisms of the age barrier

• Nothing “magical” happens between 17 years, 364 days and 18 years, 1 day which materially changes the ADME characteristics, response to or safety profile of any drug (so far) • We include adults aged 18-80 in clinical trials, but data indicate that ADME, responses and safety profile differ more between 18- and 80 year-olds that between 18- and 16-year-olds – so is the issue really around consent or regulatory approval? • In a number of countries, the age at which individuals may consent in their own right is <18 years (UK, Austria, Ireland, Finland, some Sha’ria law countries) • So, the consent issue can be managed – but what is the “right” age? • Especially ex-US, the adult/pediatric demarcation is often blurred • Physicians treat both adult and pediatric patients, esp. rare diseases • Adolescents are commonly moved to adult wards out of children’s wards

The Organisation for Professionals in Regulatory Affairs

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