From the article:
The legal papers calling for the trial to be scrapped show that in late summer 2025 the MHRA set out 19 grounds for not accepting the KCL team’s research. Another public body, which advises ministers on the safety, efficacy and quality of drugs, the Commission on Human Medicines, agreed with the MHRA. The KCL trial team responded to the regulator’s grounds for non-acceptance on 9 October; their letter, which has been made public, includes the MHRA’s objections.
Among these were concerns that some of the language in the proposed criteria for subjects’ inclusion in the trial was “open to subjective interpretation”; that more clarity was needed on the dosing of drugs; that additional exclusion criteria were required; and that more safety monitoring was needed. Most significantly, the MHRA argued that the study’s follow-up period for the children taking part was “inadequate to assess the long-term benefits and risks” of suppressing puberty in this group of children and young people.
“Identified risks include but [are] not limited to, effect on fertility preservation, bone mineral accrual, fracture risk, cognitive development and sexual function which requires monitoring,” the MHRA said. It pointed out that “many of these outcomes will only become measurable in adulthood” and therefore necessitated “a follow-up for a period of up to 20 years or until the participant reaches the end of physical maturation (whichever is shorter)”.
Ultimately, the trial’s follow-up period was not extended. The regulator accepted KCL’s response that follow-up into adulthood would occur through the NHS Register, which children would be encouraged to join. This, the trial team said, would “provide passively collected long-term data into adult life that includes long-term safety surveillance”.
Encouraged to join???