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1672225

registered interest
date	22/11/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether she is taking steps to encourage NHS Trusts to offer clinical staff the opportunity to work on research trials.
tabling member constituency	Leeds North East
tabling member printed	Fabian Hamilton
uin	3104
answer	answer is ministerial correction date of answer 28/11/2023 answer text <p>The Vision for the Future of UK Clinical Research Delivery (2021) sets out our commitment to create a research positive culture across the National Health Service and to a develop a sustainable and supported research workforce, offering rewarding opportunities and exciting careers for all healthcare and research staff of all professional backgrounds.</p><p> </p><p>Funding provided through the National Institute for Health and Care Research (NIHR) infrastructure sustains a critical mass of people who are actively involved in conducting and delivering research in the NHS and other health and care settings. This enables clinicians and other health professionals working in the NHS to undertake research, by funding posts or reimbursing NHS trusts for the time their staff are engaged in research. In addition, via the NIHR Clinical Research Network, the NIHR funds front-line research delivery staff who work throughout the NHS and other health and care research settings.</p><p> </p><p>In August 2023, NIHR also announced £30 million additional funding to support health and care professionals (HCPs) to include research in their careers and help them develop as highly skilled researchers and research leaders. The additional funding will strengthen and expand existing opportunities and introduce new initiatives. This will include new NIHR Regional Research Leadership offices to promote and coordinate research opportunities for HCPs at a regional level.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 28/11/2023 12:44:37 answering member 4044 label Biography information for Andrew Stephenson
tabling member	415 label Biography information for Fabian Hamilton

1669432

registered interest
date	13/11/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps her Department is taking to help ensure that (a) new clinical trials have the support they need to recruit patients and (b) patients are made aware of clinical trials as a potential way to access new medicines.
tabling member constituency	Alyn and Deeside
tabling member printed	Mark Tami
uin	1458
answer	answer is ministerial correction date of answer 16/11/2023 answer text <p>The Department funds research through the National Institute for Health and Care Research (NIHR). NIHR invests in expertise, specialist facilities, a research delivery workforce and support services to support recruitment to clinical trials. The NIHR Clinical Research Facilities support the delivery of early phase trials and the NIHR Clinical Research Network (CRN) and Patient Recruitment Centres support delivery and participation in later phase clinical trials.</p><p>The NIHR also provides the online platform 'Be Part of Research' which allow users to search for and register interest in clinical trials, matching people to trials of relevance to them.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 16/11/2023 17:23:48 answering member 4044 label Biography information for Andrew Stephenson
tabling member	1383 label Biography information for Mark Tami

1668608

registered interest
date	08/11/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps he is taking to implement recommendation 27 of Commercial clinical trials in the UK: the Lord O’Shaughnessy review, published on 25 May 2023.
tabling member constituency	Hove
tabling member printed	Peter Kyle
uin	868
answer	answer is ministerial correction date of answer 17/11/2023 answer text <p>The Government will publish a full response to the Lord O’Shaughnessy independent review into commercial clinical trials in autumn 2023.</p><p>The response will include an update on progress and implementation of the initial five headline commitments and foundational actions that the Government made in May 2023 as well as all other recommendations in the review.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 17/11/2023 12:48:28 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4505 label Biography information for Peter Kyle

1663689

registered interest
date	13/10/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to recommendation 7 of the independent report entitled Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report, published in May 2023, what plans the Government has to (a) set and (b) meet annual targets for increasing commercial clinical trials in the UK.
tabling member constituency	West Suffolk
tabling member printed	Matt Hancock
uin	201542
answer	answer is ministerial correction date of answer 17/10/2023 answer text <p>The Government will publish a full response to the Lord O’Shaughnessy independent review into commercial clinical trials in autumn 2023.</p><p>The response will include an update on progress and implementation of the initial five headline commitments and foundational actions that the Government made in May 2023.</p> answering member constituency Colchester answering member printed Will Quince grouped question UIN 201541 201543 201544 201545 201546 question first answered 17/10/2023 11:52:33 answering member 4423 label Biography information for Will Quince
tabling member	4070 label Biography information for Matt Hancock

1663690

registered interest
date	13/10/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to recommendations 14 and 15 of the independent report entitled Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report, published in May 2023, what plans the Government has to promote research (a) opportunities and (b) campaigns among clinicians and the public.
tabling member constituency	West Suffolk
tabling member printed	Matt Hancock
uin	201543
answer	answer is ministerial correction date of answer 17/10/2023 answer text <p>The Government will publish a full response to the Lord O’Shaughnessy independent review into commercial clinical trials in autumn 2023.</p><p>The response will include an update on progress and implementation of the initial five headline commitments and foundational actions that the Government made in May 2023.</p> answering member constituency Colchester answering member printed Will Quince grouped question UIN 201541 201542 201544 201545 201546 question first answered 17/10/2023 11:52:33 answering member 4423 label Biography information for Will Quince
tabling member	4070 label Biography information for Matt Hancock

1663692

registered interest
date	13/10/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to recommendations 2 and 3 of the independent report entitled Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report, published in May 2023, whether the Government has taken steps to reduce the (a) regulatory burden of and (b) turnaround time for approving clinical trials.
tabling member constituency	West Suffolk
tabling member printed	Matt Hancock
uin	201545
answer	answer is ministerial correction date of answer 17/10/2023 answer text <p>The Government will publish a full response to the Lord O’Shaughnessy independent review into commercial clinical trials in autumn 2023.</p><p>The response will include an update on progress and implementation of the initial five headline commitments and foundational actions that the Government made in May 2023.</p> answering member constituency Colchester answering member printed Will Quince grouped question UIN 201541 201542 201543 201544 201546 question first answered 17/10/2023 11:52:33 answering member 4423 label Biography information for Will Quince
tabling member	4070 label Biography information for Matt Hancock

1662007

registered interest
date	19/09/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether it is his Department's policy to authorise novel pharmaceutical products, therapies or medical devices for first-time human clinical trials by the MHRA on a case-by-case basis without relying on a standardised complement of pre-clinical animal toxicity or efficacy data; and what steps he is taking to promote the use of non-animal pre-clinical data.
tabling member constituency	Clacton
tabling member printed	Giles Watling
uin	200502
answer	answer is ministerial correction date of answer 17/10/2023 answer text <p>There is no United Kingdom legislation that mandates animal testing. We do, however, work to a series of International Council of Harmonisation and Committee for Medicinal Products for Human Use guidelines that describe ways to evaluate different non-clinical aspects of medicines, many of which use animals. These aspects include safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenicity, reproductive toxicity, phototoxicity, and immunotoxicity.</p><p>The non-clinical assessors have always taken the approach that data from a suitably validated model that has been demonstrated to be predictive could be submitted in lieu of animal data. On a case-by-case basis, a non-clinical assessor will also accept appropriate justifications for not conducting animal tests, for example, no pharmacologically relevant species.</p><p>In terms of promoting use of non-animal methods, we do not consider this to be within the remit of non-clinical assessors. Rather, it is for those using these methods to tell the Medicines and Healthcare products Regulatory Agency (MHRA) how they have validated them, or at least why they rely on the results and an assessor will then judge whether the data is appropriate to support the trial. The MHRA supports the developers of products by its offer of scientific advice services, the Innovation Office and the Innovative Licensing and Access Pathway.</p><p>The MHRA fully supports the National Centre for the 3Rs (Replacement, Reduction and Refinement), and agency staff play an active role in projects to support adoption and adherence to the 3Rs principles in medicines regulation worldwide.</p> answering member constituency Colchester answering member printed Will Quince question first answered 17/10/2023 11:41:51 answering member 4423 label Biography information for Will Quince
tabling member	4677 label Biography information for Giles Watling

1652049

registered interest
date	11/07/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what progress his Department has made in implementing the recommendations of the Commercial clinical trials in the UK: the Lord O’Shaughnessy review, published 25 May 2023.
tabling member constituency	Newcastle upon Tyne Central
tabling member printed	Chi Onwurah
uin	193376
answer	answer is ministerial correction date of answer 14/07/2023 answer text <p>On 26 May the Government published its initial response to the Lord O’Shaughnessy review into commercial clinical trials in the United Kingdom. This welcomed all recommendations in principle and made five headline commitments. A fuller response on all the recommendations and an implementation update and longer-term plan will be published in the autumn.</p> answering member constituency Colchester answering member printed Will Quince question first answered 14/07/2023 13:45:05 answering member 4423 label Biography information for Will Quince
tabling member	4124 label Biography information for Chi Onwurah

1649373

registered interest
date	30/06/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps the Medicines and Healthcare products Regulatory Agency is taking to reduce the time it takes to assess human challenge clinical trials.
tabling member constituency	Bethnal Green and Bow
tabling member printed	Rushanara Ali
uin	191919
answer	answer is ministerial correction date of answer 05/07/2023 answer text <p>The Medicines Healthcare products Regulatory Agency (MHRA) is aware that customers who have submitted initial applications and amendments to our Clinical Investigations and Trials team have experienced extended timeframes in some cases and understands how this unpredictability is impacting companies. The MHRA has taken several significant steps to address the extended timeframes for clinical trial approvals. This includes, but is not limited to, prioritising recruitment and training of specialist staff, working with external stakeholders to streamline and improve its processes, and enhancing customer service support and communications. The MHRA regularly reviews and prioritises applications based on public health impact, patient safety and patient need. Unless a human challenge trial application is considered to meet those criteria it is not prioritised over other clinical trial applications.</p> answering member constituency Colchester answering member printed Will Quince question first answered 05/07/2023 15:19:28 answering member 4423 label Biography information for Will Quince
tabling member	4138 label Biography information for Rushanara Ali

1649374

registered interest
date	30/06/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare products Regulatory Agency expedites human challenge trial applications where a case has gone beyond its 60-day review deadline.
tabling member constituency	Bethnal Green and Bow
tabling member printed	Rushanara Ali
uin	191920
answer	answer is ministerial correction date of answer 05/07/2023 answer text <p>The Medicines and Healthcare product Regulatory Agency (MHRA) is dealing with queued applications sequentially. However, the MHRA is reallocating work and routinely evaluates applications for their complexity and prioritises applications based on public health impact, patient safety and patient need. This approach applies to all queued clinical trials including human challenge trial applications that have exceeded the 60-day review deadline.</p> answering member constituency Colchester answering member printed Will Quince question first answered 05/07/2023 15:20:54 answering member 4423 label Biography information for Will Quince
tabling member	4138 label Biography information for Rushanara Ali