Earth Day 2025

Earth Day 2025

The UKCRC Registered CTU Network is pleased to celebrate Earth Day 2025, a day dedicated to environmental protection and sustainability. Earth Day, which began in the United States in 1970, became a global event in 1990, uniting people worldwide in the fight for a healthier planet.

Our Commitment to Sustainability

Over a number of years, the Network has supported work to identify and minimise the carbon footprint of clinical trials and promote a more sustainable approach both centrally and amongst our members.

In June 2024, we proudly became a supporter of the Concordat for the Environmental Sustainability of Research and Innovation Practice.

Sustainable Initiatives

As a network we have reduced the number of face-to-face national meetings we hold and transitioned to providing online meeting materials for all our events. 

We have increased the number of webinars, roundtables, and discipline-specific ‘clinics’ we host online, allowing more CTU staff to benefit from shared learning and peer-to-peer support without the need for travel. This shift not only reduces our environmental impact, but also significantly enhances accessibility.

Our Operations Groups work collectively to identify issues in their areas and find ways to mitigate against them. In August 2024, our Monitoring Group released a new resource aimed at helping Clinical Trials Units (CTUs) minimize the carbon footprint of their monitoring activities. Travel for on-site monitoring is a major contributor to the carbon footprint of clinical trials, for example, accounting for an estimated 10-15% of the total environmental impact. This work was highlighted in a debate in the House of Lords in March 2025, underscoring the importance of sustainability in clinical research.

A number of our member CTUs have taken part an initiative across the sector supported at various times by the NIHR and the TMRP to first quantify the carbon footprint of clinical trials, utilising the breadth and depth of leading trials expertise within CTUs to do so, complementing the knowledge brought by industry partners. More recently, they have developed tools to help researchers understand the impact of their intended trial protocol and make evidence-based decisions to minimise that impact.  These tools will be piloted across the Network.

Future Plans

We are also excited to announce the imminent release of our strategy for 2025-2030, which will embed environmental sustainability as a core value in all our activities.

As a Network, we foster collaboration among Clinical Trials Units (CTUs) to refine approaches, streamline processes, and share best practices. Our commitment to innovation and learning ensures that trials are designed and delivered with excellence, maximising impact while minimising waste.

Together, we can make a difference. Happy Earth Day 2025!

Generic trial animations available for use across the Network

At the end of 2022, three CTUs from the network (Oxford Clinical Trials Research Unit (OCTRU), Nottingham CTU, and Cardiff Centre for Trials Research received funding from the NIHR Efficient Clinical Trials Call for the EXPLAIN initiative (https://explain.octru.ox.ac.uk/). The EXPLAIN initiative was funded around the topic of Animated Explainer Videos (AEVs) – short videos/animations (up to 2 minutes) which can be used to help individuals understand more about taking part in a trial. 

The team surveyed the network about their use of AEVs and of the 35 CTUs that replied found that they had already been used by 24 CTUs.  AEVs were being used both for generic trial topics and also for the specifics of an individual trial to either explain the rationale for the trial or the interventions. For the 11 CTUs not using the technology at the time of the survey the most common reasons cited were a lack of expertise and lack of resources including the costs to produce them.

The EXPLAIN initiative funded the production of 3 AEVs on generic clinical trial topics in multiple languages to be made available free of charge to all CTUs across the network.  Through a modified Delphi survey, the EXPLAIN team also asked key trial stakeholders (including patients, site staff, and CTU staff trial) to rate generic trial topics which they thought would be useful to be produced into AEVs. 

The Delphi resulted in the creation of 3 AEVs, co-produced with patient partners who participated in the survey: What is informed consent? What is randomisation? and Safety in clinical studies.  All 3 AEVs are available in English, Welsh, Romanian, Polish, Panjabi, and what we think might be the first-time usage for such AEVs, in British Sign Language.  All are also available with subtitles in each of the languages.

To view the English versions of the animations please visit https://explain.octru.ox.ac.uk/animations.html and to request copies for any of your trials or CTU websites please complete the request form on that page.

The team will be looking at the usage of the animations – collecting metrics of their access and will also use a short questionnaire 12 months after creating individual links to each AEV to assess the usage and trial teams comments on the value of each AEV on their trial.

The EXPLAIN team wish to express their thanks to every CTU that responded to the survey, those that participated in the Delphi, and most important the PPI partners who co-produced the AEVs.  

Professor Otavio Berwanger Appointed Chair of UKCRC Registered CTU Network’s International Registration Review Committee

The UKCRC Registered CTU Network is pleased to announce the appointment of Professor Otavio Berwanger as the new Chair of its International Registration Review Committee (IRRC).

Professor Berwanger will oversee the Network’s registration process, working with the Network’s leadership to ensure maintenance of appropriate quality standards and helping to shape the strategic direction of the registration process and membership.

Commenting on his appointment, Professor Berwanger said:

“I am honoured to be appointed Chair of the UKCRC Clinical Trials Unit Network Registration Committee. The UK is a global leader in clinical trials and evidence generation, driven by a commitment to innovation, excellence, and efficiency. The UKCRC registration process plays a vital role in maintaining the highest standards for Clinical Trials Units, ensuring they are well-equipped to design and deliver high-quality research that improves patient-important outcomes. I look forward to working with colleagues and partners across the Network to support and strengthen this essential foundation for clinical trial excellence.”

Prof Otavio Berwanger

Professor Berwanger is cardiologist and clinical trialist with a strong background in leading large-scale, pragmatic, international randomised clinical trials.  He is the Executive Director of The George Institute for Global Health UK and  Chair in Clinical Trials at Imperial College London.

Reflecting on the importance of the IRRC’s work, Simon Denegri, Chair of the Network’s Executive Group, welcomed Professor Berwanger’s appointment, stating:

“I am delighted that Otavio will be chairing our International Registration Review Committee (IRRC) and look forward to working with him on behalf of the UKCRC CTU Network Executive Group. Clinical trials units (CTUs) are at the forefront of excellence and innovation in trials across all four nations of the UK and the Network is internationally unique in bringing together the collective expertise of CTUs to ensure continuous improvement in the way the UK conducts trials  The Network’s shared commitment to excellence is underpinned by the  work of IRRC which is crucial in ensuring all members of our network are operating to the highest standards and for patient benefit. Otavio brings with him a wealth of expertise and experience which will ensure the registration process for CTUs is rigorous, fair and forward-looking.”

The IRRC undertakes and has oversight of the Network’s registration process.  This assesses the capability of a Clinical Trials Unit to design, conduct and analyse clinical trials. Registration acts as a hallmark of quality, excellence and integrity and provides assurance to the standard of studies undertaken by Registered units. 

Joyce Fox, a public contributor with extensive experience in public involvement in clinical research and member of the IRRC since 2022, noted:

“It is a great pleasure to welcome Otavio as the new chair of our International Registration Review Committee (IRRC). He has extensive experience in clinical trials and demonstrates a highly inclusive and forward-looking approach, including a strong commitment to supporting and further developing Patient and Public Involvement (PPI). I am excited to work with Otavio on the IRRC and to continue supporting the development of the Clinical Trials Network and strong PPI within it.”

Professor Berwanger joins a notable line of past chairs, including Dr Ian Hudson, former Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA). His leadership is expected to further strengthen the integrity and excellence of the UKCRC Registered CTU Network’s registration process.

Monitoring Group’s ‘Greener Monitoring’ work raised in Parliament

The importance of sustainability in clinical research was highlighted during a recent debate in the House of Lords.

Green Party Peer, Natalie Bennett, referenced the work of the Network’s Network Monitoring Group on Greener Clinical Trial Monitoring, as well as the Greener Trials Toolkit developed by the ICR-CTSU and colleagues during the House of Lords Committee debate on the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024.

Ms Bennett noted that, whilst bodies like the UKCRC CTU Network and the NIHR were publishing guidance and promoting sustainable practices, these were voluntary schemes.  She queried whether the Government was considering providing a statutory basis for such activities.

With growing awareness of the environmental impact of clinical trials, the integration of sustainable practices into core trial activities is becoming a key priority and by taking a considered approach, we can reduce environmental impact whilst maintaining the highest levels of quality and oversight.

A big thank you to everyone involved in driving these important conversations forward!  We look forward to seeing further progress in this area.

Find out more about the Network’s Guidance for Greener Clinical Trial Monitoring here.

How to be a Great Chief Investigator for Clinical Trials

In 2024, the Network ran three How to be a Good CI workshops in association with Leeds CTRU, Nottingham CTU, and the Centre for Trials Research in Cardiff. Over 100 delegates took part across the three sessions.

The response was overwhelmingly positive and we are pleased to say that more sessions are being planned for 2025 and 2026, under the name How to be a GREAT CI for clinical trials.

These workshops are designed for current and aspiring Chief Investigators of clinical trials, with a clear objective: to equip you to excel in conducting clinical trials through effective collaboration with a clinical trials unit. Each event provides expert guidance and interactive activities within a collaborative learning environment.

Join us for this developmental experience, where you will gain valuable insights, forge essential connections, and expand your capabilities as a Chief Investigator.

Information on the 2024 workshops, including speaker information and previous agendas, can be found here.

Dates for the 2025 programme will be published shortly.

Monitoring triggers and metrics tool released

The Monitoring Group has published an Excel-based tool to help trial teams design trial specific monitoring metrics, triggers and associated actions, to be included in a trial monitoring plan.

The tool includes a number of worked examples to provide additional context.

All metrics listed in the tool are generic prompts, which are routinely used by many Clinical Trials Units (CTUs). However, it is expected that these are selected and tailored to the individual trial and inline with CTU processes.

Download your copy of the guidance here.

International Clinical Trials Methodology Conference 2024

We had a wonderful time at the International Clinical Trials Methodology Conference (ICTMC) in Edinburgh in October 2024.  It could have lasted two weeks, and we still wouldn’t have had time to attend all the sessions we wanted to! It’s wonderful to see how much methodology work is going on in CTUs.

We were very pleased to see that there was an exceptionally strong Network presence, with member CTUs involved in 10 pre- or post-conference workshops, 70 presentations, 2 symposia, and 2 spotlight sessions – not to mention countless posters!

On the first day of the main conference, the Network held a showcase session introduced by Kerry Hood around ‘Putting innovative trial designs into practice’.  Many thanks to Sharon Love (MRC CTU at UCL), Carrol Gamble (Liverpool Clinical Trials Centre), Faye Wolstenhulme (Newcastle CTU), Sarah Dunn (Newcastle CTU), and Andrew Farmer (HTA) for their contributions to such a fascinating and well attended session.

Later that day, we hosted an informal networking event for CTU Directors, Group Chairs, and other colleagues.

The Network had a dedicated stand in the exhibition hall which proved to be a popular meeting point for CTU delegates during the 4-day meeting – as well as a place to cast votes and contribute to the ongoing development of the Network’s strategy for 2025-2030.  We also fielded a lot of questions from overseas delegates who were interested in the work of the Network and understanding how the model could be replicated in their own countries.

Once again, we asked Directors to identify the session that they felt was likely to have the biggest future impact.  There was stiff competition, but ultimately the award was won by the FACTS (Flourishing As Clinical Trial Staff) study.  The FACTS study team are working with clinical trial staff and other academics to develop guidance for CTUs in order to help them improve employee workplace wellbeing (flourishing). Congratulations to Sophie Hall & Evgenia Riga (Nottingham CTU). You can read more about this important study here.

Once again, we asked Directors to identify the session that they felt was likely to have the biggest future impact.  There was stiff competition, but ultimately the award was won by the FACTS (Flourishing As Clinical Trial Staff) study.  The FACTS study team are working with clinical trial staff and other academics to develop guidance for CTUs in order to help them improve employee workplace wellbeing (flourishing). Congratulations to Sophie Hall & Evgenia Riga (Nottingham CTU). You can read more about this important study here.

As part of our ongoing support for the conference, and in recognition of the critical role that public contributors play in delivering successful trials, we contributed to the Patient Research Partners Bursary Scheme.  This provided the four successful applicants with funding of up to £1,000 to cover travel, accommodation, meals, and conference registration.

It’s great to see this conference going from strength to strength and we look forward to seeing you in Birmingham in September 2026!

Transforming Clinical Research: New Regulations Laid Before Parliament

Today, the UK Government introduced a landmark framework for clinical trials to Parliament, paving the way for improved patient care, greater innovation in the NHS, and a thriving life sciences sector.

The new regulations aim to streamline trial processes, enhance safety and transparency, and accelerate the delivery of groundbreaking treatments. By modernizing the UK’s clinical trials landscape, this framework reaffirms the nation’s position as a global leader in cutting-edge medical research, ensuring patients benefit from the latest advances in healthcare.

The UKCRC Registered Clinical Trials Unit Network, which represents over 50 UKCRC-accredited CTUs nationwide, welcomes this transformative initiative and looks forward to contributing to the development of the underpinning guidance.

The full government announcement can be read here.

Update from the PeRSEVERE Project

2024 has been a busy and important year for the PeRSEVERE (PRincipleS for handling end-of-participation EVEnts in clinical trials REsearch) Project.

Read on to find out more.

What is PeRSEVERE?

PeRSEVERE at the ICTMC 2024

PeRSEVERE Resources

Publications

CRF review & guidance


What is PeRSEVERE?

The PeRSEVERE project was started within the Registered CTU Network in 2019 to address the lack of detailed guidance for managing ‘withdrawal’ of consent and other participation changes in our trials. Participation changes can be complex, and it can be unhelpful to view them as binary – i.e. to view the only possible participation statuses as ‘taking part’ or ‘withdrawn’.

Motivated by what they thought shouldn’t be happening in their trials, a multi-disciplinary group came together to try to agree how participation changes should be managed. This eventually led to development of the PeRSEVERE guiding principles. The principles and all accompanying guidance and resources are available at https://persevereprinciples.org/.


PeRSEVERE at the 2024 International Clinical Trials Methodology Conference (ICTMC)

PeRSEVERE had several outputs at the ICTMC.

– They held another educational workshop to explore the PeRSEVERE principles and how they can be implemented in real-life scenarios.

– They presented a poster on how we have disseminated the broad range of guidance included in PeRSEVERE.

– A trial team at the Leeds CTRU presented a poster on implementing PeRSEVERE within their trial, with a specific focus on providing participants with the information they might want or need at the time they stop taking part.

The two posters can be viewed on the Leeds CTRU ICTMC page: https://lictrxictmc.my.canva.site/.


PeRSEVERE Resources

There are now 10 pages of resources available via the PeRSEVERE website: https://persevereprinciples.org/resources/.

These help CTUs implement the PeRSEVERE principles, and can be used either as they are in their downloadable form, or to inform development of local CTU templates or trial-specific documents.

The latest resources added are:

– Template study protocol content with suggestions for how the content about managing participation changes could be organised, and suggested wording.

– Two additional scenarios showing how the PeRSEVERE principles can help manage (or avoid) the sorts of complex participation change scenarios that can arise in trials. These scenarios were included in the ICTMC educational workshop mentioned above.


Publications

Two publications have so far come from the PeRSEVERE-related work on end-of-participation communications:

– A paper about their guidance and how it was developed with a group of public contributors

– A paper reporting the results of a survey of REC members for their views on the communications guidance

They are also working on a publication about the PeRSEVERE principles themselves and the public consultation they ran to inform their development.


CRF review & guidance

In another spin-off project from PeRSEVERE, members of the PeRSEVERE team and the Trial Methodology Research Partnership’s retention working group conducted a scoping review to see what data trial teams collect about participation changes. The initial results of this work were also presented at ICTMC. They will be used to generate some guidance for good practice in collecting data about participation changes, which will be shared with all CTUs in due course.


Red4Research 2024

The Red4Research campaign, launched in 2020, was initially created to honour the remarkable contributions of the clinical research community during the early stages of the pandemic. However, clinical research plays a vital role beyond times of crisis. The Department of Health and Social Care (DHSC) has emphasized that research is the most powerful tool for advancing healthcare by identifying new ways to prevent, diagnose, and treat disease.

We are encouraged by two government reports from the current and previous government that both highlight the importance of clinical research to the UK. In his 2023 review of clinical trials, Lord O’Shaughnessy highlighted the “success in early-stage and academic-led research [was] a strength to be celebrated”, recognizing initiatives like IMPACT and the Trials Acceleration Programme, that CTUs are involved in.

Similarly, Lord Darzi’s report on the NHS in England underscored the transformative power of research innovations to enhance treatment effectiveness and deliver solutions where they were previously unavailable. We welcome his focus on research and innovation as key drivers of improved patient care. His report also highlighted the critical role of clinical academics in bridging research and clinical practice, and stressed the need for a strong research workforce within the NHS, alongside a more prominent patient voice. A heartening recognition of the value of clinical research.

Today, Red4Research continues to serve as a platform to celebrate the work of everyone involved in clinical research, from participants to supporters and professionals. The contributions made by staff across the Network, who play a key role in world-class, practice-changing research that improves outcomes for patients and their families deserves to be loudly celebrated during this Red4Research.

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