Clinical trials unit: Difference between revisions
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Clinical Trials Units design, centrally coordinate and analyse clinical trials and other well-designed studies. |
Clinical Trials Units design, centrally coordinate and analyse clinical trials and other well-designed studies. |
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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. |
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. |
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Revision as of 08:36, 15 April 2010
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Clinical Trials Units design, centrally coordinate and analyse clinical trials and other well-designed studies. 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.
Some CTUs have expertise in specific phases and types of clinical trials, others have expertise in all phases and types of trial.
Why do Clinical Trials Units exist?
Clinical Trials Units(CTUs)aim to provide expertise in the design, conduct and analysis of clinical trials, and to meet regulatory and governance requirements.
Clinical Trials Units can provide the full spectrum of expertise required to produce high quality research. Such high quality expertise is crucial to the development of research activity and in response to this, the UKCRC created a registration process which identifies CTUs capable of coordinating multi-centre clinical trials to the highest standards.
The UKCRC have developed a Registered Clinical Trials Units website in order to provide comprehensive information and direct contact details for the UKCRC Registered CTUs. The website can be used as a resource for researchers and funders wishing to identify Registered CTUs that have expertise in coordinating multicentre clinical trials, as well as in trial design, randomisation systems, trial managment, data management and analysis.
What is the difference between Full and Provisionally Registered Units
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.
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
Notes
References
As of this edit, this article uses content from "Mental Health and Neurosciences Clinical Trials Unit", which is licensed in a way that permits reuse under the Creative Commons Attribution-ShareAlike 3.0 Unported License, but not under the GFDL. All relevant terms must be followed.
- 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