Context
The PATHWAYS puberty blocker trial has undergone a thorough independent review and received all regulatory approvals. However, Rosie Duffield raises concerns based on the US Department of Health and Human Services’ report that highlights significant long-term harm from pediatric medical transition.
Question
What discussions has he had with King’s College London on the compliance of the PATHWAYS puberty blocker trial with the Medicines for Human Use (Clinical Trials) Regulations 2004?
Answer from The Minister for Secondary Care (Karin Smyth)
The PATHWAYS trial has undergone a thorough independent review and has received all the regulatory and ethical approvals. The sponsors of the study, King’s College London and South London and Maudsley NHS foundation trust, are working to ensure that it is conducted in compliance with the relevant regulations.
Not addressed: Did not directly address the rationale or evidence supporting the medicalization approach beyond referencing Dr Hilary Cass's report.
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