Module232025

12/05/2025

“We encourage sponsors, regulators, ethics committees, and investigators to challenge research orthodoxy related to adolescent inclusion in adult research and seek trial solutions grounded in science that address more timely regulatory approval of medicines for adolescent use.”

C. Bucci-Rechtweg et al., Strategies to facilitate adolescent access to medicines: Improving regulatory guidance, Clinical Trials 2023, Vol. 20(1) 13–21

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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The Voice of the Adolescent Patient - An iCAN Survey

What is the opinion of adolescents on this subject? – The international Children's Advisory Network iCAN conducted a short online survey in March 2023 to gain some insights into the inclusion of adolescents into adult trials. Members of iCAN aged 12 to 17 years were consulted for their opinion on being included in an adult trial prior approval in adults.

Responses from 25 adolescents: – Positive step for adolescents to be included in earlier adult trials, safety of the treatment is their main concern. – Willing considering joiningan adult trial , butneedclear and age-appropriate study education material, tailored for the parents and the patient. – Important to involve the adolescent in assenting – Request for additional time , extra support for adolescents, full transparency from the study sponsor and investigators, comfort aids and safe spaces to support them in trials

ICAN = International Children Advisory Network Source: Fortrea/iCAN survey March 2023

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

44