Newcastle Clinical Trials Unit (NCTU) was established in 2003 and achieved full registration status as a UKCRC registered clinical trials unit in 2007 (registration number 22). NCTU is also in receipt of NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) CTU ‘NIHR Clinical Trials Unit Support' funding.
We support the trials and studies we help to design through:
- conduct, management and monitoring
- analysis, interpretation and reporting
In respect of trial conduct and management, the focus of NCTU is on sponsor-level activities and overall project management. Conduct and management of site-level activities is the remit of other Newcastle Academic Health Partners.
Clinical trials support
NCTU provide support to a wide range of trial types including Phase III and IV pharmaceutical trials, device trials and surgical trials, as well as those of service organisation & delivery, and of complex interventions aimed at behaviour change amongst professionals, patients and members of the public. We support both single- and multi-centre trials. We work with investigators from across the UK and internationally.
In collaboration with colleagues in the other Newcastle Academic Health Partners, we are also developing capacity and expertise in early phase trials (in particular Phase II).
In addition to clinical trials, NCTU supports studies employing a range of quantitative and qualitative research methods in preparation for the design and conduct of a future trial (including systematic reviews, feasibility and pilot studies, and the development and validation of patient reported outcome measures), as well as methodological studies relating to trial design, conduct and data interpretation.
The National Institute for Health Research (NIHR) has produced an informative video highlighting the role that Clinical Trials Units (CTUs) play in developing an NIHR funding application, explaining both the role and benefits of working with CTUs.
Clinical trials staff
We have a core clinical trials team of senior trial managers, trial managers and clinical trial administrators, and database managers/programmers. We have a close relationship with the Institute of Health and Society including experts in biostatistics, health economics, qualitative methods and behavioural sciences.