How to work with Clinical Trials Units: a guide for clinicians and academics

Engaged early, a Clinical Trials Unit (CTU) can be a strategic partner throughout the entire research lifecycle, helping teams make better decisions about study design, feasibility, statistical approach, and regulatory strategy. But how does it all work?

Contents:

1. What is a Clinical Trials Unit?
2. Are all CTUs the same?
3. How can a CTU support your trial?
4. When should a team engage with a CTU?
5. How to start collaborating with NCTU
6. What happens during the clinical trial?
7. Tips for successful collaboration
8. Get in touch
   
   

What is a Clinical Trials Unit?

A Clinical Trials Unit is a specialist centre that designs, conducts, analyses and reports on clinical trials and other well-designed studies. They vary in size and specialism, but all have expertise in supporting high-quality, regulatory-compliant and impactful trials.

For clinical trials in the UK, look for CTUs registered with the UK Clinical Trials Unit Network. This means they’ve been assessed by the independent International Registration Review Committee for rigorous processes and ongoing capability. It means they have proven their ability to coordinate the full trial lifecycle to the highest standards.

Are all CTUs the same?

Whilst there is common practice shared across CTUs and all have the capability to deliver a wide range of trials, there are strengths that are particular to each Unit.

A partner like Newcastle Clinical Trials Unit (NCTU) can support the whole trial lifecycle, and has experience across a wide range of trials, such as:

• regulated trials, including CTIMPs (Clinical Trials of Investigational Medicinal Products), ATIMPs (Advanced Therapy Investigational Medicinal Products) and medical devices
• interventional trials including surgical and complex interventions
• observational longitudinal studies
• pilot and feasibility studies
• statistical expertise in trial design, analysis and reporting
• randomised and non-randomised designs
• sample collection studies
• studies within trials (SWATS)

NCTU currently manages over 25 active trials, and has a team of trial managers, data managers, and quality assurance managers. Recent work ranges from reducing antibiotic use in sepsis, to evaluating a novel cell therapy designed to support immune recovery after stem cell transplantation in children with rare immune conditions.

Particular strengths of NCTU include an excellent track record in rare disease research, a portfolio of rare disease trials in a variety of therapeutic areas, innovative statistical approaches that support complex trial designs, and novel approaches to delivery that make trials more streamlined, efficient and participant-friendly.

NCTU also works with commercial partners to design, set up, and deliver clinical trials and other research studies. We can also connect commercial partners with academic experts from across Newcastle University, bringing together the clinical, methodological and subject-specific expertise needed to develop and evaluate new treatments, technologies and interventions. 

Members of the multidisciplinary NCTU team, bringing together expertise from across trial management, data management, quality assurance, and methodology.

How can a CTU support your trial?

A UK CTU Network unit has proven expertise in:

• methodological input into design
• grant applications
• trial protocols
• sponsorship applications
• HRA and regulatory submissions
• feasibility assessment and site set-up
• data collection and management
• project management
• safety, pharmacovigilance and risk assessment
• statistical analysis plans and analysis
• monitoring, recruitment and retention
• reports and publications

CTUs enrich and support across the whole research cycle:

Trial design

Is there a question or challenge to solve? NCTU can help establish the most effective and efficient way to approach this, advising on everything from sample sizes to ethical issues.

Support could include:

• identifying funding streams and presenting the application to funders
• refining the research questions
• choosing the most appropriate trial design, including economic evaluation and qualitative components
  participant selection, strategies and sampling
• choosing outcome measures and evidence synthesis/systematic review
• feasibility issues, ethical issues and regulatory and governance requirements
• investigational medicinal product procurement
• resource requirements including costing the proposal and scheduling trial timelines and milestones
• advice on oversight committees, including a trial steering committee and an independent data monitoring and ethics committee

Governance

Clinical trials regulations are essential but can feel complex to navigate. Meeting national and international requirements – such asMHRA guidance in the UK or the ICH E6 Good Clinical Practice standards – is specialised work. NCTU has the experience to help you build good governance and guide you through legislation.

Recruitment

A trial will not be able to answer a research question or test a hypothesis if participant recruitment isn’t successful. NCTU has strong relationships across healthcare settings and established NIHR infrastructure that supports recruitment across a broad geography. The team can help design recruitment and retention strategies as well as informed consent procedures.

Delivery and monitoring

Clinical trials typically involve multiple work streams, including data management and cleaning, safety monitoring, site management, protocol deviation reporting, sponsor oversight and more. Delivery and management of trials requires specialist skills which NCTU has in abundance, while clinicians and researchers are free to focus on the scientific aspects of the trial.

Analysis and reporting

Statistical expertise is vital to robust trial design.

A key advantage of working with NCTU and Biostatistics Research Group colleagues is the improved efficiency of clinical trials through better innovative design and analysis approaches. NCTU also works with colleagues from across the wider University, including experts in health economics, qualitative methods, and behavioural sciences.

When should a team engage with a CTU?

Even if a research idea is only beginning to take form, it’s never too early to connect with a CTU.

There might only be an initial research question, a potential funding route in mind, or a rough sense of the trial type you are considering. Early engagement with a CTU can offer a real strategic advantage.

If involved before the trial begins, the CTU can offer expertise to:

• identify funding options and strengthen grant applications through the CTU’s experience, insights and long-established relationships with funders
• many funders require a UK Clinical Trials Unit Network CTU to be named in funding applications
• identify potential feasibility risks before they become problems, for example by analysing recruitment strategies and making sure the participant pool matches the trial’s goals
• ensure the statistical plan is appropriate and transparent to funders and reviewers, drawing on specialist statistical expertise to ensure transparency and accuracy
• advise on regulations so the trial meets compliance requirements from the outset, including the 2026 updates to the MHRA guidelines
• ensure the necessary data is captured to answer research questions, and that this data is accurate and withholds the integrity of trial results

Involving a CTU team early maximises the chances of attracting funding, running a high-quality trial, and generating robust results, meaningful evidence, changes in clinical practice, and papers or publications that will aid future funding applications.

How to start collaborating with NCTU

What should you bring to the initial conversation? How formal does your approach need to be? 

Less than you might think. 

A first conversation with the CTU could simply cover a short summary of the research question, some initial ideas about trial type, timeframes, and funding intentions.

From there, the CTU can advise on how they can support the development of trial design and applications for funding. This includes feasibility of delivery, resources, timescales, and what the next steps might look like. 

Simply send the team an email to start the process.

What happens during the clinical trial?

During the trial: working effectively together

A productive working relationship with a CTU is built on clarity and communication. When working with a CTU, it helps to:

• follow clear governance structures, including who holds overall sponsor responsibilities, who leads on regulatory submissions, and how and when decisions will be escalated
• hold regular progress reviews with investigators, trial managers, and site staff to report on recruitment, protocol deviations, and safety signals
• treat the CTU team as collaborators with shared ownership of the trial's objectives and success - this helps to keep everyone motivated
• be responsive to questions about data, safety, and protocol to keep the trial moving
• plan for the unexpected and seek CTU advice if there are recruitment challenges, protocol amendments, or external pressures

After the trial: analysis, reporting, and impact

A CTU team can support with post-trial activities including statistical analysis, safety reporting, final regulatory submissions, manuscript preparation, and publication support.

The CTU can also offer advice about impact beyond the primary publication, helping to answer questions such as:

• how could the evidence be presented to support changes in clinical practice or policy?
• is there a communications strategy? How will you communicate findings to the public and to stakeholders?
• will there be follow-on research?

It’s important to plan for data management and archiving at the end of a trial, particularly for regulated trials where data must be retained for specified periods. The CTU team can advise on your responsibilities. 

Tips for successful collaboration

Newcastle Clinical Trials Unit has more than twenty years of experience across hundreds of trials.

These principles support effective partnerships:

Make contact early

Working with a CTU early means they can add greater value, smooth the path to funding, approval, and delivery, and learn from previous trials to improve trial design and conduct.

Prioritise feasibility

Trial plans should be realistic and deliverable. Recruitment targets, timelines, budgets, outcome measures and data collection plans should be developed collaboratively to ensure feasibility.

Plan your dissemination from the beginning

Research impact is easier to demonstrate when the foundations — participant recruitment and involvement, outcome selection, and follow-on plans — are built into the design.

Invest in the relationship

Budget pressures, funding requirements and stakeholder timelines all affect the trial. Sharing these with the CTU means navigating such challenges together.

Clinical trials are significant undertakings, often over a long period of time. Building trust and mutual understanding through close working with the CTU team pays dividends across the life of the trial. The CTU’s expertise and experience will boost the trial's successes and help to manage problems that arise.

Get in touch

A Clinical Trials Unit is a specialist, professional, expert team that works alongside clinical and academic researchers. If you’re only considering CTU support for trial compliance, you could be missing a huge opportunity.

Think of the CTU as a strategic partner and as part of the team. They will help design better studies, secure essential funding, navigate regulatory complexity, and ultimately deliver findings that make a difference in people’s lives.

After decades of conducting high-quality research, the Newcastle Clinical Trials Unit has developed the infrastructure, expertise, and relationships to benefit a wide range of trials. If you’re thinking about a clinical trial, it’s never too early to get in touch.

You might also like…

• read the blog: Can innovative statistical analysis support rare disease clinical trials?
• discover the work of Newcastle Clinical Trials Unit