Clinical Trials

Clinical Trials

What are clinical trials?

Clinical trials are experiments or observations in clinical research. Such studies are designed to answer specific questions about treatments or interventions. Clinical trials generate data on safety and efficacy and aim to ensure the scientific validity and reproducibility of results.

RDS NE have close links to the Clinical Trials Units in Newcastle and Durham. If you are seeking funding for a clinical trial, staff from the RDS will liaise with the appropriate trials unit to organise this support for your application. If you require input from the trials unit in the conduct of your study this should be costed into your application; they will advise on specific costs. Please see the role of CTUs in preparing your research application video on our resources page.

Newcastle Clinical Trials Unit

NCTU is a UK CRC fully registered Clinical Trials Unit (registration number 22) and was established in 2003. They have a core team of expert staff who can assist with the design, conduct and analysis of RCTs, and other high quality studies. With respect to conduct, NCTU’s focus is on sponsor-level activities, project and data management. To this end, they implement systems and procedures to ensure compliance with ethical, regulatory and research governance guidance and legislation. Mark Walker is the Acting Director of NCTU and the Unit is one of the Newcastle Biomedicine Clinical Research Platforms.

For more information please contact nctu-enquiries@ncl.ac.uk by email: or by telephone 0191 208 7623.

Durham Clinical Trials Unit

The Durham Clinical Trials Unit (DCTU) was established in 2009 and brings together a team of academics within Durham University who enjoy working with health and social care professionals to design and deliver clinical and social care trials. Our involvement may include leading the design, coordination and analysis of clinical studies, or assisting NHS organisations within the North of England. We help to develop clinical-academic partnerships that deliver patient-oriented research. We particularly welcome clinicians who want to develop their research portfolio and share our journey. Rebecca Maier and Helen Hancock are co-Directors of the DCTU, leading a team experienced in designing and delivering clinical trials and other research designs.

For more information please contact the unit by email: dctu@durham.ac.uk or by telephone 0191 334 0345.

Why you may want to include CTU support

  • both CTUs support investigators in study design and the preparation of trial grant applications to prestigious funding bodies, in the ongoing management of trials and in analysing and reporting study findings;
  • they also support studies preparing for definitive trials;
  • the CTUs are experienced in coordinating multi-centre randomised controlled trials and have quality assurance systems in place to ensure compliance with regulations and legislation.

What expertise can the CTU offer

  • the CTUs offer expertise at all stages in the set-up, conduct, completion, and close-down of a trial;
  • specific activities that can be carried out by the CTU include:
    • Trial set-up: contribution to protocol development, advice on trial design, advice on appropriate outcome measures, contributions to ethical and feasibility issues, randomisation strategy, trial resource requirements, advice on membership of Trial Steering and Data Monitoring Committees and applications to MHRA, HRA and R&D
    • Trial conduct: pharmacovigilance, initiation and monitoring, regulatory reports and reports to funders, data management, organisation of management meetings, submission of accrual data to NIHR portfolio
    • Trial completion and close-down: preparation of final reports, preparation of papers for journals and conferences, close-down reports and data archiving.

What to think about before meeting a CTU advisor

  • the CTUs will work with you to turn your knowledge and expertise into a fully developed trial proposal and subsequently to produce the essential trial documents that are required by the MHRA, HRA and R&D;
  • prior to meeting with a CTU you should think about your potential collaborators and participating sites prior to meeting;
  • the CTUs will be able to advise on working across Trusts, the devolved nations, Europe and North America and Canada.

Useful Resources

SPIRIT guidance (Standard Protocol Items Recommendations for Interventional Studies)

http://www.spirit-statement.org/publications-downloads/

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

http://www.ideal-collaboration.net/recommendations/

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.

https://www.precis-2.org/

Kirsty Loudon, Shaun Treweek, Frank Sullivan, Peter Donnan, Kevin E Thorpe,  Merrick Zwarenstein. The PRECIS-2 tool: designing trials that are fit for purpose BMJ 2015;350:h2147. doi: 10.1136/bmj.h2147