Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will take steps to ensure that the PATHWAYS trial does not adversely affect a participant’s future access to NHS care.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.
One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530.
This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.
The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.
The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment has been made of the compatibility of the PATHWAYS trial with the Cass Review recommendations on clinical caution and evidence thresholds.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.
One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530.
This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.
The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.
The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether children previously discharged from NHS gender services will be eligible for the PATHWAYS trial.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.
One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530.
This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.
The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.
The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he plans to review national protocols that require the automatic cessation of Clozapine following a single red blood result, in the context of cases where such results have subsequently been found to be spurious.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Clozapine is used to treat people with schizophrenia in whom other medicines have not worked and it is also used to treat severe disturbances in the thoughts, emotions, and behaviour of people with Parkinson’s disease in whom other medicines have not worked.
Clozapine is associated with potentially life threatening side effects including the risk of agranulocytosis. Patients must have regular blood tests to ensure their white blood cell count doesn’t drop too low which is classified as a red result. Clozapine may only be taken if the patient has a normal blood count.
As with all medicines, the safety of clozapine is kept under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA) using a number of data sources including reports of suspected side effects through the Yellow Card Scheme, data from marketing authorisation holders, and research published in the scientific literature.
The MHRA is currently reviewing the blood monitoring requirements associated with clozapine, to ensure these continue to minimise the risk of agranulocytosis whilst allowing patients to access clozapine when needed. Currently, the product information for clozapine, including the summary of product characteristics states that patients must stop clozapine if a red result is obtained and that they should not be re-exposed to clozapine.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of completing the Data Linkage Study to help inform safe PATHWAYS trial design.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence.
The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data.
Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530
It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones.
The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial.
After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what criteria will be used to decide whether PATHWAYS trial participants are offered cross sex hormones at the end of the study.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence.
The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data.
Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530
It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones.
The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial.
After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether (a) detransitioners and (b) whistleblowers were consulted in the design of the PATHWAYS trial.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence.
The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data.
Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530
It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones.
The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial.
After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what safeguarding measures are in place to ensure that families do not feel pressured into the PATHWAYS trial.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence.
The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data.
Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530
It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones.
The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial.
After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he made of the potential merits of (a) a feasibility study and (b) external peer review of the PATHWAYS trial.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence.
The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data.
Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530
It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones.
The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial.
After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.
Asked by: Sarah Pochin (Reform UK - Runcorn and Helsby)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of including a control group of children who receive no puberty suppression in the PATHWAYS trial.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence.
The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data.
Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link:
https://fundingawards.nihr.ac.uk/award/NIHR167530
It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones.
The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial.
After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.