The MHRA twice rejected my full FOIR but has now supplied a copy of the 7th Nov 2025 letter to Kings Health Partners about the Pathways Puberty Blockers Trial.
https://www.whatdotheyknow.com/request/mhraandkingscollegelondonpa/response/3407657/attach/html/4/2.03%20CTA%20Acceptance%20of%20Amended%20Request%2014%20redacted.pdf.html
07/11/2025
Dear [REDACTED],
THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004 S.I. 2004/1031
Our Reference: СТА 14523/0296/001-0001
IRAS ID: 1011645
PRODUCT: Decapeptyl, Decapeptyl, Prostap, Gonapeptyl, Zoladex
Protocol number: 3646-PATHWAYS
NOTICE OF ACCEPTANCE OF AMENDED REQUEST
I am writing to inform you that the Licensing Authority, having reviewed your application in collaboration with the Research Ethics Committee, accepts your amended request for a clinical trial authorisation (CTA), with effective received date of 25/08/2025.
COMBINED REVIEW MEDICAL - Remarks: *REMARKS
Clinical Remarks:
The following comments are for future consideration / information only and do not affect the approval status of your study. No response is required.
- The sponsor is reminded that at the end of the trial, all trial activities (e.g., IMP dosing or access to the IMP, follow- up visits, or data collection) must be completed. Therefore. IMP treatment or access to the IMP cannot continue as part of this trial once the protoco-defined end of the trial is reached.
For post-trial access, the sponsor should note that under UK legislation the provision of unlicensed medicines is only possible either within an approved and active clinical trial or, for an individual patent i.e., not as part of a study. under the remit of Guidance Note 14: The Supply of Unlicensed Medicinal Products ('Specials').
- While the proposed safety monitoring is considered acceptable for the monitoring of the individual participants included in this clinical trial, the sponsor should be aware that different monitoring requirements may be necessary to support any change in the terms of the marketing authorisation for the licensed products used in this CTA.
Statistical Remarks:
The following comments are for future consideration information only and do not affect the approval status of your study. No response is required.
i. The sponsor is advised that in study design use of too many stratification factors may be less successful at achieving balance.
ii. The sponsor is advised to consider the burden to participants when assessing a large number of outcomes, balancing the need for information versus completeness of data. Considerations should be given to ranking the various outcomes in terms of their importance to patients as well as to support regulatory decision making.
iii. Regarding analysis method, the sponsor is advised that use of a treatment policy strategy for handling death is not acceptable since data after death do not exist.
iv. The sponsor is reminded that intervals following Bayesian principles have a fundamentally different interpretation compared to the intervals described which follow a frequentist statistical approach. Results based on frequentist approach will be required for regulatory decision making. Furthermore, Bayesian methods should be "calibrated" to have good frequentist properties in particular with regards to type I error control. Therefore. it is important to assess the operating characteristics of the Bayesian design (e.g. power and type I error rate).
The authorisation is effective from the date of this letter although your trial may be suspended or terminated at any time by the Licensing Authority in accordance with regulation 31. You must notify the Licensing Authority within 90 days of the trial ending.
You are reminded that a favourable opinion from the Ethics Committee is also required before this trial can proceed, changes made as part of your amended request may need to be notified to the Ethics Committee. If not already provided, please follow the guidance on our website on informing us of the registration status of your trial (where applicable).
You are reminded that from 1 January 2022 you will need to comply with the requirements specified in the following guidance, where applicable:
Import of IMPs from listed countries to GB: https://www.gov.uk/government/publicatons/importing-investigational-medicinal-products-into-great-britain-from-approved-coumtries
Supply of IMPs to Northern Ireland:
https://www.gov.uk/guidance/supplying-investigational-medicinal-products-to-northern-ireland
Substantial amendments to clinical trials:
https://www.gov.uk/guidance/guidance-on-substantial-amendments-to-a-clinical-trial
Any required substantial amendment to your Clinical Trial Authorisation should be submitted and approved as soon as possible and before 1 January 2022.
Yours sincerely.
Clinical Trials Unit MHRA
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That is the letter referred to in this letter from the MHRA to Kings College London:
https://assets.publishing.service.gov.uk/media/6998b06d047739fe61889efb/Sponsor-letter110226.pdf
Which is linked on this page:
News story
MHRA statement on the PATHWAYS puberty blocker trial
20 Feb 2026
https://www.gov.uk/government/news/mhra-statement-on-the-pathways-puberty-blocker-trial
I am not sure if the 7 Nov 2025 MHRA letter tells us much more - I am a bit distracted by this coming in the same day as the local elections. I am standing for Party of Women and I am dashing off out again now.