Generic trial animations available for use across the Network

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.

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