Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of progress toward the target set in the Life Sciences Sector Plan, published on 16 July 2025, to reduce clinical trial set-up time to 150 days by March 2026.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is committed to cutting the current time it takes to get a clinical trial set up, to under 150 days by March 2026, with the aim of making the United Kingdom a world leader in clinical trials.
Data published on 15 April 2026 on GOV.UK as part of the UK Clinical Research Delivery Programme’s key performance indicators report show that average set-up times for commercial interventional clinical trials have reduced from 169 days to 122 days, when comparing the same period this year to last. This is significant progress toward the Government’s target to cut clinical trials set-up times to within 150 days.
The target set in the Life Sciences Sector Plan is that by March 2026, 95% of commercial interventional trials in England deliver set up within 150 days. Data published on 15 April 2026 on GOV.UK as part of the UK Clinical Research Delivery key performance indicators report shows that 78% of commercial interventional studies starting set-up in September 2025 met the 150-day target.
Performance data against the target will be published monthly with the final view of all studies that commenced set-up by March 2026 published in October 2026.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to ensure that the United Kingdom remains internationally competitive in attracting cell and gene therapy trials, including CAR-T; and to ensure that patients can access innovative treatments without delay.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is committed to turbocharging clinical research and delivering better patient care, to make the United Kingdom a world-leading destination for clinical research including cell and gene therapies such as CAR-T. We are working to fast-track clinical trials to drive global investment into life sciences, improve health outcomes, and accelerate the development of medicines and therapies of the future, including gene therapy treatments.
The Department funded National Institute for Health and Care Research (NIHR) funds research and research infrastructure, which supports patients and the public to participate in high-quality research, across the development pathway.
The NIHR Industry Hub, launched in October 2025, provides a single front door for companies in England, coordinating research infrastructure into one coherent, streamlined offer.
NIHR infrastructure offers innovators access to world-leading expertise, facilities, and support for the delivery of clinical trials, strengthening the UK’s position as a partner of choice for cell and gene therapy studies. The NIHR’s Biomedical Research Centres and Experimental Cancer Medicine Centres support early translational and experimental medicine studies, offering world-leading scientific expertise and clinical capability for complex, early phase, and first-in-human trials, including CAR-T. This helps de-risk development and attract cutting-edge studies to the UK.
NIHR’s Clinical Research Facilities provide specialist environments and the skilled workforce required to deliver these complex therapies safely and efficiently. To improve delivery at scale, the NIHR’s Research Delivery Network and Commercial Research Delivery Centres are established to support rapid and efficient delivery of clinical trials and provide dedicated capacity and capability across the country. This will further enhance the UKs competitiveness by improving the speed and reliability of study setup and delivery.
In addition, the NIHR supported Advanced Therapy Treatment Centres (ATTCs) play a key role in the development of advanced therapy medicinal products clinical trials. By developing national infrastructure, standardising delivery pathways, and supporting centres across a range of geographies, ATTCs help ensure that advanced therapies can be delivered beyond a small number of highly specialised sites.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many clinical trials offering CAR-T therapy for low-grade lymphoma have closed in the last three years, and what the reasons were in each case.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
Answering this question would require Medicines and Healthcare products Regulatory Agency staff to go through a vast volume of protocol documents manually. This is because the information is not held in such a way to be able to filter electronically by the requested category.
The Guide to Parliamentary Work sets out that there is an advisory cost limit known as the disproportionate cost threshold which is the level above which departments can decide not to answer a written question. The current disproportionate cost threshold is £850.
The Guide to Parliamentary Work is published online and is available on the GOV.UK website.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government which specific CAR-T treatments are available for individuals with low grade lymphomas.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS England funds the use of licensed medicines that have been recommended by the National Institute for Health and Care Excellence (NICE), or the off-label use of licensed indications that have been approved via the NHS England clinical policy process.
NICE has evaluated and recommended several CAR-T therapies for both high-grade and low-grade lymphomas, some of which are recommended for a period of managed access, for instance:
To support implementation of NICE recommendations, NHS England sets clinical treatment criteria to ensure that treatments are made available to those intended by the NICE Guidance. Clinical input helps set the clinical and patient treatment criteria based on the NICE committee deliberations, how the treatment will be used within the treatment pathway, and the evidence base considered by NICE and the Medicines and Healthcare Products Regulatory Agency.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what support they are providing to NHS Trusts to restore or replace paused CAR-T clinical trials, to prevent patients being left without viable treatment pathways.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is committed to turbocharging clinical research and ensuring that all patients, including those with cancer, have access to cutting-edge clinical trials and innovative, lifesaving treatments.
Decisions about whether a specific clinical trial should be paused are the responsibility of the study sponsor and research team, who closely monitor any reported patient safety concerns and other data that could impact a decision for an individual trial to be halted.
To support National Health Service trusts to deliver clinical trials, the Department funds research and research infrastructure across England through the National Institute for Health and Care Research, which supports patients and the public to participate in high-quality research, including on CAR-T therapy.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they have carried out an impact assessment on the effect of halted CAR-T clinical trials, and whether they will publish that assessment.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is committed to turbocharging clinical research and ensuring that all patients, including those with cancer, have access to cutting-edge clinical trials and innovative, lifesaving treatments.
The Department has not carried out an impact assessment on the effect of halted CAR-T clinical trials. This is because decisions about whether a specific clinical trial should progress or not are the responsibility of the study sponsor and research team involved, who closely monitor any reported patient safety concerns and other data that could impact this decision.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what the current NHS eligibility criteria are for CAR-T therapy for both high-grade and low-grade lymphomas.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS England funds the use of licensed medicines that have been recommended by the National Institute for Health and Care Excellence (NICE), or the off-label use of licensed indications that have been approved via the NHS England clinical policy process.
NICE has evaluated and recommended several CAR-T therapies for both high-grade and low-grade lymphomas, some of which are recommended for a period of managed access, for instance:
To support implementation of NICE recommendations, NHS England sets clinical treatment criteria to ensure that treatments are made available to those intended by the NICE Guidance. Clinical input helps set the clinical and patient treatment criteria based on the NICE committee deliberations, how the treatment will be used within the treatment pathway, and the evidence base considered by NICE and the Medicines and Healthcare Products Regulatory Agency.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of infusion capacity within the NHS for blood cancer treatments.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
No assessment has been made of infusion capacity within the National Health Service for blood cancer treatments. However, it is a priority for the Government to support the NHS to diagnose and treat cancer, including blood cancer, as early and quickly as possible. The Department is committing to this by delivering an extra 40,000 operations, scans, and appointments each week, to support increased capacity.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to ensure haemato-oncology services have the capacity to plan and adopt new innovations in the treatment of blood cancer.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Disease Registration Service, through the National Cancer Registration and Analysis Services, collects information on how many people in England have blood cancer, labelled as haematological neoplasms. This data supports service provision and commissioning in the National Health Service, clinical audits, and public health and epidemiological research, all of which contributes to improved outcomes for cancer patients, including blood cancer patients.
The Department is committed to implementing the recommendations of Lord O'Shaughnessy’s review into commercial clinical trials, making sure that the United Kingdom leads the world in clinical trials, and ensuring that innovative, lifesaving treatments are accessible to NHS patients, including those with blood cancer.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking steps to prioritise the use of cost and clinically effective cancer medicines that result in fewer patient visits to hospital.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) makes recommendations on whether all new medicines, including cancer medicines, should be routinely funded by the National Health Service based on an assessment of their costs and benefits. The NHS in England is legally required to fund medicines recommended by the NICE, and cancer medicines are eligible for funding from the Cancer Drugs Fund from the point of positive draft NICE guidance.
In determining whether a medicine represents a clinically and cost effective use of NHS resources, the NICE takes into account the impact of new medicines on health outcomes and the health and care system, including where costs may be incurred and where savings may be realised.