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969206
registered interest false more like this
date less than 2018-09-06more like thismore than 2018-09-06
answering body
Department of Health and Social Care remove filter
answering dept id 17 more like this
answering dept short name Health and Social Care remove filter
answering dept sort name Health and Social Care more like this
hansard heading Clinical Trials remove filter
house id 1 more like this
legislature
25259
pref label House of Commons more like this
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. more like this
tabling member constituency Leicester South more like this
tabling member printed
Jonathan Ashworth more like this
uin 171464 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2018-09-13more like thismore than 2018-09-13
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 more like this
answering member printed Caroline Dinenage more like this
question first answered
less than 2018-09-13T11:00:06.01Zmore like thismore than 2018-09-13T11:00:06.01Z
answering member
4008
label Biography information for Dame Caroline Dinenage more like this
tabling member
4244
label Biography information for Jonathan Ashworth more like this
890118
registered interest false more like this
date less than 2018-04-23more like thismore than 2018-04-23
answering body
Department of Health and Social Care remove filter
answering dept id 17 more like this
answering dept short name Health and Social Care remove filter
answering dept sort name Health and Social Care more like this
hansard heading Clinical Trials remove filter
house id 1 more like this
legislature
25259
pref label House of Commons more like this
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. more like this
tabling member constituency Liverpool, Wavertree more like this
tabling member printed
Luciana Berger more like this
uin 137168 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2018-04-26more like thismore than 2018-04-26
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 more like this
answering member printed Caroline Dinenage more like this
question first answered
less than 2018-04-26T11:21:29.013Zmore like thismore than 2018-04-26T11:21:29.013Z
answering member
4008
label Biography information for Dame Caroline Dinenage more like this
tabling member
4036
label Biography information for Luciana Berger more like this
822994
registered interest false more like this
date less than 2018-01-15more like thismore than 2018-01-15
answering body
Department of Health and Social Care remove filter
answering dept id 17 more like this
answering dept short name Health and Social Care remove filter
answering dept sort name Health and Social Care more like this
hansard heading Clinical Trials remove filter
house id 1 more like this
legislature
25259
pref label House of Commons more like this
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. more like this
tabling member constituency Liverpool, Wavertree more like this
tabling member printed
Luciana Berger more like this
uin 122677 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2018-01-18more like thismore than 2018-01-18
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 more like this
answering member printed Jackie Doyle-Price more like this
question first answered
less than 2018-01-18T15:30:53.217Zmore like thismore than 2018-01-18T15:30:53.217Z
answering member
4065
label Biography information for Dame Jackie Doyle-Price more like this
tabling member
4036
label Biography information for Luciana Berger more like this
818990
registered interest false more like this
date less than 2018-01-09more like thismore than 2018-01-09
answering body
Department of Health and Social Care remove filter
answering dept id 17 more like this
answering dept short name Health and Social Care remove filter
answering dept sort name Health and Social Care more like this
hansard heading Clinical Trials remove filter
house id 1 more like this
legislature
25259
pref label House of Commons more like this
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. more like this
tabling member constituency Bristol West more like this
tabling member printed
Thangam Debbonaire more like this
uin 121667 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2018-01-17more like thismore than 2018-01-17
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 more like this
answering member printed Jackie Doyle-Price more like this
question first answered
less than 2018-01-17T14:41:19.227Zmore like thismore than 2018-01-17T14:41:19.227Z
answering member
4065
label Biography information for Dame Jackie Doyle-Price more like this
tabling member
4433
label Biography information for Thangam Debbonaire more like this