Module232025

12/05/2025

Analysis of Inclusion of Adolescents in Adult Trials – ICON’s Experience

9 Studies across Atopic Dermatitis and Haematology indications and various phases were polled to gain insight on impact of inclusion of adolescents

1 Study reported a delay in enrolling adolescence compared to adult participants while 8 studies did not report any delays in adolescent enrollment compared to adult All 9 studies reported no issues in development of study materials or adolescent site start up 8/9 trials included adolescent population in original protocol; 1 trial included adolescents during protocol amendment and opened additional adolescent sites after FPI 2 Study teams raised concern with adolescent patient retention which required additional efforts from study teams and sites to keep participants engaged

Multiple studies had consistent adolescent enrollment which contributed positively to overall study enrollment metrics

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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Outcome under BPCA and/or PREA (2012–2018) - Simultaneous drug approvals for both populations

Drug products

Biological products

46 trials were conducted on 23 products under BPCA and/or PREA for drug products

There were 4 biological products approved under BPCA and/or PREA in the combined trials.

The most commonly studied therapeutic area under BPCA and/or PREA for drug products was pulmonology, which consisted of 33% (15/46) of the total studies and 22% (5/23) of the total drug products

Pulmonology (75%) and allergy (25%) were the only two therapeutic areas for these combined trials

All products received simultaneous FDA-approval in adults and for the paediatric population included in the combined trial for the indication studied

The paediatric population included in the combined trial was approved concurrently with the adult population in all cases

Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018 I. Tanaudommongkon et al., Clin Pharmacol Ther. 2020 November ; 108(5): 1018–1025

The Organisation for Professionals in Regulatory Affairs

54

M Dehlinger-Kremer, 14 May 2025

54