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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 more like this
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