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| '''Clinical trials units''' ('''CTU''') are specialised ] units which design, centrally coordinate and analyse ] and other studies. Some CTUs specialise in different methodologies, such as ], ], surgical trials, and health services research. Some specialise in one disease type, whereas others are generic units. Some CTUs focus on specific phases and types of clinical trials; others conduct all phases and types of trial. | |||
| {{csb-pageincluded|1=http://www.clinicaltrialsunit.com}} | |||
| ==United Kingdom== | |||
| ⚫ | |||
| ===What does a CTU do?=== | |||
| CTUs design, centrally coordinate and analyse clinical trials and other well-designed studies. For more detailed information, go to; | |||
| The UKCRC evaluates CTUs in the UK and they may be given either Full or Provisional CTU registration status. All Registered CTUs are required to provide evidence that their work is of high quality by demonstrating (1) experience of coordinating multi-centre randomised controlled trials or other well-designed studies, (2) a presence of a core team of expert staff to develop studies, (3) a presence of robust quality assurance systems and processes to meet appropriate regulations and legislation, and (4) evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio.<ref name="MHNCTU">{{cite web | url = http://www.clinicaltrialsunit.com/ | title = Mental Health and Neurosciences Clinical Trials Unit | work = clinicaltrialsunit.com | accessdate = 2010-04-15 | url-status = dead | archiveurl = https://web.archive.org/web/20110512110149/http://clinicaltrialsunit.com/ | archivedate = 2011-05-12 }}</ref> | |||
| ⚫ | Provisional CTUs tend to be newer and evolving CTUs and have not yet built a track record but have relevant expertise and experience that is worth building on. Evaluation criteria for Provisional Registration were developed for CTUs that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration in the future.<ref name="MHNCTU"/> | ||
| Medicinal clinical trials are only a subset of all trials undertaken by Registered Clinical Trials Units in the academic sector. Such Units may also specialise in surgical trials, therapy trials and other complex interventions such as educational interventions. | |||
| Some CTUs specialise in different methodologies (for example Randomised controlled Trials, cluster randomised trials, surgical trials, health services research) and some specialise in one disease type, whereas others are generic units. | |||
| In the ], clinical trials of medicines are approved by the ]. This it does through its Clinical Trials Unit, which enforces standards through the Good Clinical Practice Inspectorate. In 2007, a revised version of Phase I clinical trial regulations was issued following the heavily publicized ] in several volunteers for a study of ].<ref name="Clark2007">{{cite book|last=Clark|first=Todd D.|title=PharmaHandbook: a guide to the international pharmaceutical industry|url=https://books.google.com/books?id=E-qs6BtdIUAC&pg=PA414|accessdate=15 April 2010|year=2007|publisher=PharmaHandbook 5th Edition|isbn=978-0-9795443-0-9|page=414}}</ref> | |||
| Some CTUs have expertise in specific phases and types of clinical trials, others have expertise in all phases and types of trial.<br /> | |||
| ===UKCRC=== | |||
| <br /> | |||
| There was a general consensus, both amongst research funders and research leaders, on the need to involve Clinical Trials Units (CTUs) in clinical research projects to ensure quality see <br /> | |||
| ===What is the difference between Full and Provisionally Registered Units=== | |||
| <br /> | |||
| All Registered CTUs have provided evidence that their work is of high quality. In order to obtain Full Registration status, | |||
| CTUs were required to demonstrate: | |||
| * experience of coordinating multi-centre randomised controlled trials or other well-designed studies | |||
| * a presence of a core team of expert staff to develop studies | |||
| * a presence of robust quality assurance systems and processes to meet appropriate regulations and legislation | |||
| * evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio. | |||
| <br /> | |||
| ⚫ | Provisional CTUs tend to be newer and evolving CTUs and have not yet built a track record but have relevant expertise and experience that is worth building on. Evaluation criteria for Provisional Registration were developed for CTUs that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration in the future | ||
| ==See also== | |||
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| ==Notes== | ==Notes== | ||
| ⚫ | {{reflist}} | ||
| <!--<nowiki> | |||
| See http://en.wikipedia.org/Wikipedia:Footnotes for an explanation of how to generate footnotes using the <ref> and </ref> tags, and the template below. | |||
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| ⚫ | {{reflist |
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| ==References== | ==References== | ||
| {{CCBYSASource|source= www.ctu.co.uk|sourcepath=http://www.clinicaltrialsunit.com/|sourcearticle=Mental Health and Neurosciences Clinical Trials Unit |revision=355974030}} | |||
| <div class="references-small"> | |||
| *Rang HP, Dale MM, Ritter JM, Moore PK (2003). ''Pharmacology'' 5 ed. Edinburgh: Churchill Livingstone. ISBN 0-443-07145-4 | |||
| *Finn R, (1999). ''Cancer Clinical Trials: Experimental Treatments and How They Can Help You.'', Sebastopol: O'Reilly & Associates. ISBN 1-56592-566-1 | |||
| *Chow S-C and Liu JP (2004). ''Design and Analysis of Clinical Trials : Concepts and Methodologies'', ISBN 0-471-24985-8 | |||
| * Pocock SJ (2004), ''Clinical Trials: A Practical Approach'', John Wiley & Sons, ISBN 0-471-90155-5 | |||
| </div> | |||
| == External links == | == External links == | ||
| {{Medical research studies}} | |||
| *{{dmoz|Business/Biotechnology_and_Pharmaceuticals/Pharmaceuticals/Products_Evaluation/Clinical_Trials/|Clinical Trials}} | |||
| * | |||
| ⚫ | {{DEFAULTSORT:Clinical Trials Unit}} | ||
| * | |||
| ⚫ | ] | ||
| * to Find Ongoing & Completed Trials of New Medicines | |||
| ⚫ | ] | ||
| * | |||
| * | |||
| * for Parkinson's disease clinical trials | |||
| * Clinical Trials search | |||
| * | |||
Latest revision as of 06:58, 19 October 2024
Clinical trials units (CTU) are specialised biomedical research units which design, centrally coordinate and analyse clinical trials and other studies. Some CTUs specialise in different methodologies, such as randomised controlled trials, cluster randomised trials, surgical trials, and health services research. Some specialise in one disease type, whereas others are generic units. Some CTUs focus on specific phases and types of clinical trials; others conduct all phases and types of trial.
United Kingdom
The UKCRC evaluates CTUs in the UK and they may be given either Full or Provisional CTU registration status. All Registered CTUs are required to provide evidence that their work is of high quality by demonstrating (1) experience of coordinating multi-centre randomised controlled trials or other well-designed studies, (2) a presence of a core team of expert staff to develop studies, (3) a presence of robust quality assurance systems and processes to meet appropriate regulations and legislation, and (4) evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio.
Provisional CTUs tend to be newer and evolving CTUs and have not yet built a track record but have relevant expertise and experience that is worth building on. Evaluation criteria for Provisional Registration were developed for CTUs that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration in the future.
Medicinal clinical trials are only a subset of all trials undertaken by Registered Clinical Trials Units in the academic sector. Such Units may also specialise in surgical trials, therapy trials and other complex interventions such as educational interventions.
In the United Kingdom, clinical trials of medicines are approved by the Medicines and Healthcare products Regulatory Agency. This it does through its Clinical Trials Unit, which enforces standards through the Good Clinical Practice Inspectorate. In 2007, a revised version of Phase I clinical trial regulations was issued following the heavily publicized multiple organ failures in several volunteers for a study of TGN1412.
Notes
- ^ "Mental Health and Neurosciences Clinical Trials Unit". clinicaltrialsunit.com. Archived from the original on 2011-05-12. Retrieved 2010-04-15.
- Clark, Todd D. (2007). PharmaHandbook: a guide to the international pharmaceutical industry. PharmaHandbook 5th Edition. p. 414. ISBN 978-0-9795443-0-9. Retrieved 15 April 2010.
References
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