Module232025

07/05/2025

ETHICS CHALLENGES IN PAEDIATRIC CLINICAL TRIALS My personal top 10 (based on ~600 protocols reviewed 2017-2023)

4 Intrusive Assessments (Tanner staging) 5 Endpoints (adult, not child, medical review for SAEs)

6 Pregnancy (child privacy, post-trial follow-up, pregnant partner) 7. Post-Trial Access to IMP (protocol ambiguous or silent, toxicology) 8. Communication of Trial Results (onus on participants, child to adult) 9. “Aging Out” (no process, incorrect process) 10. Paediatric Assent and Information Sheets (length, complexity)

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Intrusive assessments (Tanner Staging)

• Commonly used to gauge age or developmental stage at which pregnancy tests and contraception are “necessary” – not applicable to all adolescents 12 • If participant denies sexual activity, it may be ethically questionable to impose such procedures. 13 • Most clinicians consider pubertal staging an intimate examination, but documentation of consent and use of formal chaperones is not standard practice. The use of a parent as a chaperone is common but not recommended. 14 • Direct examination of hairiness, the breast and the external genitals can be experienced as an intrusive procedure. 15 • An adolescent abstinent at the inclusion in a clinical trial may become sexually active over time, a situation that needs to be regularly monitored. • Competent minor adolescents have the right to privacy and confidentiality. • Meaning of sexuality and of adolescent sexual behaviour differs widely from one culture or religion to another. 16 Are all paediatricians competent to conduct such examinations? Involve paediatric endocrinologists?

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