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Clinical Trials

Clinical Trials

What are clinical trials?

Clinical trials are research studies that compare a new or different treatment (intervention) with the best treatment currently available, or compare two (or more) treatments, to see which one works best. Occasionally trials investigate just one treatment with no direct comparison. They test whether the new or different treatment works, and is safe and effective, assessing any risks and benefits. Results guide and optimise treatment for patients and members of the public.

Many clinical trials are conducted on drugs and on medical devices; if there is no standard treatment, the new treatment can be compared with no treatment or with a ‘dummy’ treatment (or placebo). Clinical trials can also compare different types of treatment, such as behavioural interventions, surgery, or other interventions such as rehabilitation.

Clinical Trials Unit

Clinical Trials Units (CTUs) are specialist units with a remit to design, develop, conduct, analyse and publish clinical trials and other well-designed studies.

They provide specialist expert statistical, and other methodological advice alongside management expertise; they can offer collaboration to enable rigorous and successful clinical trials. Many CTUs have expertise in clinical trials involving investigational medicinal products (CTIMPs) and devices; these must be conducted in compliance with The Medicines for Human Use (Clinical Trials) Regulations.

CTUs awarded UKCRC Registration provide evidence to an international panel of experts of their capability in the design and conduct of multi-centre clinical trials; these CTUs have overall responsibility for design, development, rigorous conduct, recruitment, data capture, management, and analysis of a portfolio of trials, and have robust systems to ensure conduct and delivery to the highest standards.

RDS NENC have close links to Newcastle Clinical Trials Unit (NCTU), a UKCRC Registered CTU. If you are considering developing a clinical trial for which you will seek national peer reviewed funding, staff from the RDS will liaise with the trials unit to organise this support for your application. Advice is provided as part of RDS capacity; any decision to collaborate is agreed, and brings full engagement of CTU staff, with time funded as part of the trial team, from design through to dissemination.

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, led by Professor Helen Hancock and Professor Dawn Teare, comprises a team of expert staff who work in collaboration with investigators in designing, developing, conducting and analysing clinical trials. This includes systems for randomisation, data capture, management, and analysis. We provide academic collaboration in design, and throughout the lifecycle of clinical trials and studies.

For more information please discuss your proposal with RDS colleagues and / or contact or by telephone 0191 208 2522.

Why you may want to have CTU support in developing your trial/study

  • NCTU work with investigators to design and develop grant applications for trials and studies seeking national, peer-reviewed funding; in the ongoing development, conduct (management, data management, and monitoring) of trials and studies; and in analysing and reporting findings to patients and clinical communities.
  • NCTU are highly experienced in designing and conducting trials including of investigational medicinal products, devices, surgery and other interventions, using a range of clinical trial designs, including innovative designs. They support both single- and multi-centre trials national and internationally.
  • NCTU offers expertise throughout the trial lifecycle, from the design, set-up, conduct, analysis, and close-down of a trial and have quality assurance systems in place to ensure compliance with ethical, regulatory and research governance guidance and legislation.
  • NCTU works with trial sponsors, locally, nationally and internationally and from two main hubs in Newcastle and South Tees;

What to do before meeting a CTU adviser

Send the team:

The initial research question, the background to the project, ideas for the trial/study design, and the initial project plan in PICO terms (Patient group, Intervention under study, comparator (if applicable), outcomes of interest)

Any supporting information that may be helpful (previous papers on trials conducted in the area of interest), previous successful or unsuccessful grant applications relating to the planned study, details of any patient and public involvement work undertaken to date, details of potential funders (and deadlines) that you are aiming to seek funding from.

Any other details that may have already been thought of (Sponsorship, collaborators, potential participating sites)

The CTU team will discuss all of these elements with you during initial and subsequent meetings.

It is helpful to understand whether you are seeking RDS advice on its own, or whether you are seeking collaboration with the CTU for the full project; understanding this early enables us to tailor our advice, and staff resources accordingly.

Useful Resources

SPIRIT guidance (Standard Protocol Items Recommendations for Interventional Studies)

IDEAL Recommendations (Idea, Development, Exploration, Assessment, Long-term Follow up, Improving the Quality of Research in Surgery)

PRECIS-2 Tool PRagmatic Explanatory Continuum Indicator Summary- assists trialists designing clinical trials to consider where they would like their trial to be on the pragmatic/explanatory continuum.

INCLUDE: guidance to improve inclusivity in research