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Clinical trials unit

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Clinical Trials Units

What does a CTU do?

CTUs design, centrally coordinate and analyse clinical trials and other well-designed studies. For more detailed information, go to; Clinical Trials Unit


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.


UKCRC


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 UKCRC


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


See also

Notes

References

  • 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

External links