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818990

	registered interest
	date	09/01/2018
	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, if he will consider the merits of introducing a national audit system for clinical trials; and if he will make a statement.
	tabling member constituency	Bristol West
	tabling member printed	Thangam Debbonaire
	uin	121667
	answer	answer is ministerial correction date of answer 17/01/2018 answer text <p><strong></strong>All clinical trials of investigational medicinal products in the European Union are registered and information on the trial and a summary of results is made public in the EU clinical trials register, except for adult phase 1 trials which are considered commercially confidential.</p><p> </p><p>Good clinical practice (GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people. To ensure compliance with GCP, the Medicines and Healthcare products Regulatory Agency carries out inspections in the United Kingdom of organisations that are involved in clinical trials.</p><p> </p><p>The Government’s National Institute for Health Research (NIHR) which is the country’s largest public funder of health research and trials, has implemented a number of initiatives on publication of research results. The NIHR is the world’s first health research funder to publish comprehensive accounts of its commissioned research within its own publicly and permanently available journal series. The NIHR Journals Library comprises a suite of five open access peer-reviewed journals reporting results from a range of health research areas. The reports provide a full account of the research project, including methods and a full description of the results, and complement shorter articles submitted for publication in other peer-review journals, which the NIHR actively encourages researchers to do as part of their dissemination strategy. In addition – contracts for NIHR funding include requirements on publication of the results from NIHR funded and supported research.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 17/01/2018 14:41:19 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	4433 label Biography information for Thangam Debbonaire

820904

	registered interest
	date	11/01/2018
	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 he has assessed the effect of the UK losing access to the EU portal and database through which all European clinical research is processed and stored after the UK leaves the EU.
	tabling member constituency	Liverpool, Wavertree
	tabling member printed	Luciana Berger
	uin	122322
	answer	answer is ministerial correction date of answer 16/01/2018 answer text <p>The Government values the strong collaborative partnerships that we have across the European Union in the areas of science, research and innovation, and as part of Exit negotiations is working to ensure that we have the best possible environment in which to support clinical trials and new medicines after we leave the EU.</p><p> </p><p>All clinical trials of investigational medicinal products in the EU are registered and information on the trial and a summary of results is made public in in the EU clinical trials register, except for adult phase one trials which are considered commercially confidential. This information is publicly available now and similar to information that will be publicly available in the new European Medicines Agency clinical trials IT system.</p><p> </p><p>In the United Kingdom, the Medicines and Healthcare products Regulatory Agency, Health Research Authority, ethics services, National Institute for Health Research and National Health Service have been working towards implementation of the new European Clinical Trials Regulation (CTR) since it was agreed in 2014. The application date of the CTR across the EU will be set by the European Commission. The current regulatory approval legislation, portals and databases will stay in place until such time as any changes are needed so there will be no interruption in UK clinical trials approvals.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 16/01/2018 12:24:38 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	4036 label Biography information for Luciana Berger

822994

	registered interest
	date	15/01/2018
	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 assessment the Government has made of the effect of the UK no longer having access to the EU portal and database through which all European clinical research is processed and stored after the UK leaves the EU.
	tabling member constituency	Liverpool, Wavertree
	tabling member printed	Luciana Berger
	uin	122677
	answer	answer is ministerial correction date of answer 18/01/2018 answer text <p>The Government values the strong collaborative partnerships that we have across the European Union in the areas of science, research and innovation, and as part of Exit negotiations is working to ensure that we have the best possible environment in which to support clinical trials and new medicines after we leave the EU.</p><p> </p><p>All clinical trials of investigational medicinal products in the EU are registered and information on the trial and a summary of results is made public in in the EU clinical trials register, except for adult phase one trials which are considered commercially confidential. This information is publicly available now and similar to information that will be publicly available in the new European Medicines Agency clinical trials IT system.</p><p> </p><p>In the United Kingdom, the Medicines and Healthcare products Regulatory Agency, Health Research Authority, ethics services, National Institute for Health Research and National Health Service have been working towards implementation of the new European Clinical Trials Regulation (CTR) since it was agreed in 2014. The application date of the CTR across the EU will be set by the European Commission. The current regulatory approval legislation, portals and databases will stay in place until such time as any changes are needed so there will be no interruption in UK clinical trials approvals.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 18/01/2018 15:30:53 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	4036 label Biography information for Luciana Berger

890118

	registered interest
	date	23/04/2018
	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 his Department is taking to maintain competition in clinical trials after the UK leaves the EU.
	tabling member constituency	Liverpool, Wavertree
	tabling member printed	Luciana Berger
	uin	137168
	answer	answer is ministerial correction date of answer 26/04/2018 answer text <p>The Government has made clear that a key priority through the negotiations will be to ensure that the United Kingdom remains one of the best places in the world for science and innovation, including clinical trials. Every Government department, including the Department of Health and Social Care, is planning to deliver a smooth exit under any scenario, which includes preparing the UK for the future economic partnership we hope to negotiate with the European Union, as well as the very unlikely scenario in which no mutually satisfactory agreement can be reached and the UK exits without a deal.</p><p> </p><p>If the clinical trials regulation comes into force during the implementation period, as it is currently expected to do in March 2020, it will apply to the UK. The withdrawal agreement and implementation Bill will give effect to the implementation period in domestic law and will allow regulations to continue to apply in the UK for this time-limited period. If this opportunity does not come to pass, we will give priority to taking the steps necessary to bring into UK law, without delay, all relevant parts of the EU regulation that are within the UK’s control, so that those planning clinical research can do so with certainty.</p><p> </p><p>The UK is already a preferred destination for EU and global clinical trials. The Government has been clear that it is in the interest of patients and the life sciences industry across Europe for the UK and EU to find a way to continue cooperation in the field of clinical trials, and for continued sharing of data and information, even if our precise relationship with the EU will by necessity change. As part of the Department’s Exiting the EU programme, officials are working to ensure appropriate coordination across a number of projects relating to research and clinical trials including workforce, regulations, funding and rare diseases.</p><p> </p><p>The National Institute for Health Research (NIHR) provides the support, expertise and facilities that the National Health Service needs to undertake world-leading clinical trials funded by the NIHR, and other public, charity and life sciences industry partners, by funding a range of infrastructure facilities and the Clinical Research Network. Through NIHR and its partners, and by close collaboration with the life sciences sector and industry, the Government will ensure that the UK remains one of the best places in the world for research, science and innovation.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 26/04/2018 11:21:29 answering member 4008 label Biography information for Dame Caroline Dinenage
	tabling member	4036 label Biography information for Luciana Berger

969206

	registered interest
	date	06/09/2018
	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, how many NHS patients participated in a clinical trial in each of the last five years.
	tabling member constituency	Leicester South
	tabling member printed	Jonathan Ashworth
	uin	171464
	answer	answer is ministerial correction date of answer 13/09/2018 answer text <p>The infrastructure provided by the National Institute for Health Research (NIHR) Clinical Research Network (CRN) supports the set-up and timely delivery of commercial and non-commercial studies in the National Health Service in England.</p><p> </p><p>The information is not held in the format requested. The following table shows the number of people participating in research studies, rather than NHS patients participating in clinical trials.</p><p> </p><p>NIHR CRN has recruited a total of 3,220,237 participants (which will include NHS patients and members of the general population) to portfolio studies over the last five years.</p><p> </p><table><tbody><tr><td><p>Financial Year (FY) 2013/14</p></td><td><p>FY 2014/15</p></td><td><p>FY 2015/16</p></td><td><p>FY 2016/17</p></td><td><p>FY 2017/18</p></td><td><p>Total</p></td></tr><tr><td><p>604,216</p></td><td><p>618,453</p></td><td><p>605,596</p></td><td><p>666,639</p></td><td><p>725,333</p></td><td><p>3,220,237</p></td></tr></tbody></table><p> </p><p>It should be noted that this is for all research and not just clinical trials and does not include clinical trials undertaken outside of the NIHR CRN.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 13/09/2018 11:00:06 answering member 4008 label Biography information for Dame Caroline Dinenage
	tabling member	4244 label Biography information for Jonathan Ashworth

1186536

	registered interest
	date	19/03/2020
	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 guidance he has provided to regulatory and health authorities on ensuring that the UK remains an attractive place to conduct clinical trials and supply human medicines.
	tabling member constituency	Reigate
	tabling member printed	Crispin Blunt
	uin	32040
	answer	answer is ministerial correction date of answer 29/05/2020 answer text <p>The Department is working directly with the Medicines and Healthcare products Regulatory Agency, Health Research Authority, NHS England and NHS Improvement, the National Institute for Health Research and other partners across the health and life sciences sectors to ensure that the United Kingdom remains an attractive place to conduct clinical trials and supply human medicines.</p><p>The Medicines and Medical Devices Bill provides the UK the means to remain a world-leading regulator and an important market for medicines and medical devices and supports the delivery of the Life Sciences Industrial Strategy to make the UK a leading global hub for life sciences. The Bill makes clear the importance of ensuring the UK is an attractive place to bring new products to market and conduct clinical trials, specifying that before making any regulations under the Bill, the Secretary of State must consider this point.</p><p>We are determined to maintain the UK’s position as one of the best locations globally to run clinical trials.</p><p><strong> </strong></p> answering member constituency Bury St Edmunds answering member printed Jo Churchill question first answered 29/05/2020 17:04:52 answering member 4380 label Biography information for Jo Churchill
	tabling member	104 label Biography information for Crispin Blunt

1242877

	registered interest
	date	13/10/2020
	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 his Department is taking to increase the speed at which clinical trials for medical research can be conducted.
	tabling member constituency	Newcastle upon Tyne Central
	tabling member printed	Chi Onwurah
	uin	102799
	answer	answer is ministerial correction date of answer 23/10/2020 answer text <p>This Government is committed to supporting a vibrant clinical research environment. We need to make clinical trials faster, more efficient and more innovative and we need to further develop digital tools and infrastructure to support clinical research. Crucially, we need to ensure that patients and the public are engaged and involved in clinical trials so that research meets their needs. The Department and the Office for Life Sciences are working to develop a vision which will realise these goals, liaising with a range of health and care stakeholders.</p><p>The Department, through the National Institute for Health Research Clinical Research Network supports the set-up and timely delivery of commercial and non-commercial studies across England. This includes advice and support for study feasibility, streamlined National Health Service permissions and effective patient recruitment.</p> answering member constituency Charnwood answering member printed Edward Argar question first answered 23/10/2020 09:49:14 answering member 4362 label Biography information for Edward Argar
	tabling member	4124 label Biography information for Chi Onwurah

1274321

	registered interest
	date	06/01/2021
	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, if he will support Trial Development Days run by (a) the National institute for health research (NIHR) and (b) Cancer Research UK to offer advice and understanding of the methods that are required for clinicians to meet the standards for acceptance for the NIHR grant.
	tabling member constituency	Leeds North West
	tabling member printed	Alex Sobel
	uin	134110
	answer	answer is ministerial correction date of answer 12/01/2021 answer text <p>The National Institute for Health Research (NIHR) Research Design Service (RDS) provides advice and support to research teams to develop and submit high quality applied health and care grant applications to the NIHR and other national peer-reviewed funding programmes offering specialist advice on all aspects of an application. There is online research support resources available at the following link:</p><p> </p><p><a href="https://www.nihr.ac.uk/researchers/apply-for-funding/how-to-apply-for-project-funding/" target="_blank">https://www.nihr.ac.uk/researchers/apply-for-funding/how-to-apply-for-project-funding/</a></p> answering member constituency Charnwood answering member printed Edward Argar question first answered 12/01/2021 16:45:56 answering member 4362 label Biography information for Edward Argar
	tabling member	4658 label Biography information for Alex Sobel

1328912

	registered interest
	date	27/05/2021
	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 ensure that clinical trials across all disease areas are resilient to disruption from future outbreaks of covid-19 and other pandemics.
	tabling member constituency	Newcastle upon Tyne Central
	tabling member printed	Chi Onwurah
	uin	8600
	answer	answer is ministerial correction date of answer 09/06/2021 answer text <p>On 23 March 2021 the Government published its vision for the future of clinical research delivery in the United Kingdom. This includes the aim to create a research system resilient to future public health emergencies through the use of innovative trial designs and with the support of digital solutions and systems. To support this vision, we have identified five key themes which underpin the improvements we will take forward in the coming years as follows:</p><p>- Clinical research embedded in the National Health Service;</p><p>- Patient-centred research;</p><p>- Streamlined, efficient and innovative research;</p><p>- Research enabled by data and digital tools; and</p><p>- A sustainable and supported research workforce.</p><p>An implementation plan and strategy setting out how the Government will begin to deliver the vision will be published later this year.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 09/06/2021 09:35:25 answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4124 label Biography information for Chi Onwurah

1328913

	registered interest
	date	27/05/2021
	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, how many patients were recruited to clinical trials in each NHS Trust in (a) 2018, (b) 2019 and (c) 2020.
	tabling member constituency	Newcastle upon Tyne Central
	tabling member printed	Chi Onwurah
	uin	8601
	answer	answer is ministerial correction date of answer 09/06/2021 answer text <p>The National Institute for Health Research (NIHR) Clinical Research Network (CRN) supports the set-up and timely delivery of commercial and non-commercial studies in England. The number of people participating in research studies on the NIHR’s CRN portfolio is shown in the following table:</p><table><tbody><tr><td><p>2018/19</p></td><td><p>2019/20</p></td><td><p>2020/21</p></td></tr><tr><td><p>970,840</p></td><td><p>813,860</p></td><td><p>1,549,185</p></td></tr></tbody></table> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 09/06/2021 09:32:43 answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4124 label Biography information for Chi Onwurah