Clinical trials unit: Difference between revisions

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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 RCTs, 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:

• a track record and experience of coordinating multi-centre randomised controlled trials or other well-designed studies
• presence of a core team of expert staff to develop studies
• 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

External links

• Clinical Trials at Curlie
• The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• The International Clinical Trials Registry Platform (ICTRP)
• IFPMA Clinical Trials Portal (IFPMA CTP) to Find Ongoing & Completed Trials of New Medicines
• LocalClinicalTrials.com - search engine for recruiting clinical trials in the US
• ClinicalTrials.gov
• PDtrials for Parkinson's disease clinical trials
• TrialWizard.org Clinical Trials search
• UKCRC