Following a detailed review by a team of specialists from across the Network, the QA Operations Group has published updated guidance on QA oversight of laboratories.
This revised suite of materials provides guidance to CTUs assessing the suitability of laboratories processing and/or analysing samples used in clinical trials. It includes:
Guidance for CTUs assessing the suitability of Labs processing research samples
Guidance on training requirements for labs processing research samples
A flowchart for oversight of laboratories by CTUs
A Self-Assessment Questionnaire
We are very grateful for the assistance provided the MHRA in reviewing and updating this guidance, as well as the helpful feedback given by those who used the original versions.
Clinical trials units (CTUs) are involved in the running and oversight of clinical trials and other research studies. Documentation and data are produced for each study, and it is important to retain this for a period after the study ends to demonstrate good clinical practice. Wherever possible these documents and data should be stored in a format to facilitate more efficient reproduction of results.
This new guidance, published by the Data & IS Operations Group, outlines important points for CTUs to consider when creating an electronic archive for study-related data, metadata and associated documentation and may help units assess the ongoing suitability of their archiving policies and procedures.
What better way to mark World Environment Day 2024 than by becoming a supporter of the Concordat for the Environmental Sustainability of Research and Innovation Practice?
The UKCRC Registered CTU Network is pleased to announce that it has become an official supporter of the UK research and innovation (R&I) sector’s voluntary environmental sustainability concordat.
Aims of the Concordat
The Concordat is the result of a collaborative project between key members of the research and innovation sector including, but not limited to, universities, research institutes and funders.
It represents a “shared ambition for the UK to continue delivering cutting-edge research, but in a more environmentally responsible and sustainable way”.
Through a series of key themes, the Concordat aims to ensure that future research endeavours are environmentally stable. whilst maintaining the UK’s position as a leader in research and innovation.
Priority areas
The concordat has six key areas for delivery:
Leadership and system change
Sustainable Infrastructure
Sustainable procurement
Emissions from business and academic travel
Collaborations and partnerships
Environmental impact and reporting data
Ways to get involved
There are two ways to sign up to the Concordat – as a Signatory or as a Supporter. The Network has chosen to become a Supporter. This means we agree with the aims of the Concordat, but are unable to actively implement some of its priorities due to our role.
What does this mean for the Network?
In becoming a Supporter of the Concordat, we have stated our commitment to the following priority areas: Leadership, Emissions from Travel, and Collaborations & Partnership. We will report annually on our progress here on our website, as well as reporting to the UKCRC Board.
Whilst we do not have direct responsibility for issues such as procurement and estate policies, we will provide our members with tools to help support them when engaging in discussion with their host organisations on these matters.
We will also continue to continue to support the development of the Carbon Foot Printing tool for trials and champion it’s use.
Find out more
To learn more about the aims and ambitions of the Concordat click here.
To download the Network’s official letter of support please click here.
You can find out more about World Environment Day, and this year’s theme of restoration, desertification, and drought resilience, here.
The UKCRC Registered Clinical Trials Unit (CTU) Network is seeking a highly experienced person with expertise in clinical trials to Chair its International Registration Review Committee. The committee is responsible for reviewing all applications for new and ongoing membership and, as such, plays a pivotal role in ensuring that the Network continues to promote excellence and integrity in non-commercial research.
The successful candidate will have a wealth of experience, knowledge, and acumen within the field of non-commercial/academic clinical trials research, demonstrate an excellent understanding of best practice as well as current drivers for change.
As the collective voice of non-commercial and academic clinical trials units, the Network plays an important role in engaging with Government, funders, regulators, and patients to improve and strengthen clinical research in the UK. The Network is seen internationally as an exemplar for the development of national clinical trials support. It was established in 2007 and its members are committed to setting and sharing good practice and improving standards in clinical trials.
The UKCRC CTU Network is funded by its members, and major funders have representation on the Network’s Executive Group, this includes: Cancer Research UK, NIHR, Versus Arthritis, Chief Scientist Office Scotland and Health and Social Care Research Wales.
Nurses are the backbone of patient care around the world, and the importance of their role cannot be overstated.
In 1974, the International Council of Nurses (ICN) designated 12 May, the anniversary of Florence Nightingale’s birth, as International Nurses Day. The aim was to showcase the work undertaken by nurses in the interests of patient care as well as raise awareness of some of the issues within the nursing profession itself.
Over the years, these themes have included improving the resilience of health systems, better health through nursing research, and increasing access and equity. In 2024, they are focusing on how strategic investment in nursing can bring about both economic and societal benefits.
The involvement of nurses is vital for the success of clinical research in the UK and elsewhere and they form an integral part of an interdisciplinary trial team.
Whether supporting trial participants, developing their own research ideas, or educating colleagues & the public, research nurses play a pivotal role in delivering clinical research and, ultimately, improving patient care.
We are proud to work alongside them and to be able to uplift their voices.
Thank you to nurses everywhere for everything you do!
You can find out more about the ICN and this year’s campaign here: www.icn.ch/.
2023 was an exciting time for the UKCRC Registered CTU Network with changes in the research environment and opportunities to build on learning from the pandemic and transform the design and delivery of trials. There were also changes within the Network Secretariat.
In the spring, Prof Julia Brown announced that she had taken the difficult decision to stand down as Network Director. She was instrumental in the development of the Network and had led it from its inception. We are very grateful for her leadership over the previous 16 years.
Fortunately, we were able to recruit an excellent replacement in Prof Kerry Hood. Kerry is currently Dean of Research & Innovation for the College of Biomedical & Life Sciences at Cardiff University and has played a vital role with the Network since 2007, firstly as Director of the South East Wales Trials Unit and then the Centre for Trials Research.
Our various Operations and Task & Finish Groups met 60 times during the year to work on activities that are of benefit to CTUs and CTU staff across the Network. This included producing guidance, webinars, training events and, of course, the 8 national meetings we held for key staff groups including CTU Directors, statisticians, and trial monitors.
During the year, over 750 delegates from across the Network took part in face-to-face or online events. These included webinars on subjects as diverse as the Better Methods, Better Research funding programme and different approaches to data management. There were also quarterly ‘monitoring clinics’ which provided an opportunity for staff with a responsibility for trial monitoring to share experiences, solutions, and best practice.
There were more than 2000 views and downloads of our guidance and training materials. These include the training for staff undertaking clinical trial monitoring, as well as information to support units preparing to undergo MHRA inspection. All outputs can be viewed here.
The UKCRC Registered CTU Network’s PeRSEVERE Project team has launched a dedicated website bringing together all its guidance on managing participation changes in clinical trials.
PeRSEVERE focused on participants in clinical trials stopping, reducing or changing their level of involvement.
The project aimed to address the question: how should we design and carry out clinical trials and other research, given that we know some participants will stop participating early?
PeRSEVERE was a collaborative effort, involving representatives of many different clinical trials units and different areas of expertise from across the CTU Network, as well as a patient group.
The team developed high-level principles to guide management of early end of participation in clinical trials and other research studies. Between May and August 2021, they ran a public consultation on the draft principles. The responses to the consultation were used to agree the final principles and associated explanatory guidance.
Good Statistical Practice – Tailored GCP Training for Statisticians
This Good Statistical Practice training has been developed by the UKCRC CTU Statisticians Operations Group and was funded by the NIHR Clinical Trials Unit Efficient Trial Conduct Funding scheme.
It is a suite of 5 training modules which has been developed as stand-alone GCP training tailored to statisticians, incorporating relevant regulatory aspects in the first module. It is primarily intended as a resource for statistics teams to access for group training where discussion can pull in local practice, but has also been formatted to enable self-led training through the inclusion of additional notes.
An associated publication of the training overview and development process is under review and will be circulated across the Network once in press.
The modules are:
Module 1 – Core Good Clinical Practice training Module 2 – Record keeping and documentation Module 3 – Trial design, randomisation and blinding Module 4 – Data Management Module 5 – Statistical analysis and reporting
The project lead, Prof Deborah Stocken of the Leeds Clinical Trial Research Unit, said:
“I would like to thank my co-authors for their commitment in bringing these resources together, the statisticians from across the Network and NIHR who took part in piloting and providing feedback on the individual modules, and specifically the Network’s Statistics Operations Group who instigated the project. We are also grateful to NIHR Learn and the MHRA for their engagement and support. We hope all statisticians involved in clinical trials and medical research will find these resources helpful”.
A webinar providing the background to the project, the process that was taken in developing and piloting the resources, and the training modules themselves can be accessed via NIHR Learn.
We are delighted to announce that Prof Kerenza (Kerry) Hood will take up the role of Director of the UKCRC Registered CTU Network on 1st October. Her appointment follows a competitive process that started in May this year and was overseen by the Chair of the Executive Group, Simon Denegri OBE
Kerry Hood is currently Dean of Research & Innovation for the College of Biomedical & Life Sciences at Cardiff University and has played a vital role with the UK network since its inception in 2007, firstly as Director of the South East Wales Trials Unit and then the Centre for Trials Research.
Kerry’s research has centred on the conduct of complex clinical trials, mainly focusing on primary care, infections and learning disabilities.
Her leadership has been critical to the development of clinical trials in Wales and she has also been co-leading the Trial Conduct Working Group of the Trial Methodology Research Partnership for the last five years.
On her new role Kerry said:
“I’m excited by the opportunity to work with all of our brilliant CTU’s to move the network forward. We are seeing major changes in the way in which trials are designed and run and this is being led by our members, building on a set of standards and values which focus on quality, impact and public and patient involvement. It is an honour and a privilege to take the baton from Julia and build on the incredible network she has developed.”
Commenting on her appointment, Simon Denegri OBE (Executive Group Chair) said:
“On behalf of the UKCRC CTU Network members I would like to warmly welcome Kerry Hood to the role of Director of the Network. Kerry has an outstanding track record and reputation in clinical trials and clinical research and is passionate about the important role of the Network in driving innovation in clinical trials while maintaining the highest standards of quality for which the UK has become known. It says everything about the standing of the Network that we have been able to attract someone of Kerry’s calibre. As Chair of the Network Executive Group, I look forward to working with Kerry and our members to put the work of Clinical Trials Units at the forefront of all that is good about UK clinical research.”
The Network would like to extend its thanks to the outgoing Director Julia Brown. Simon Denegri said:
“Julia’s leadership has been fundamental to the successful growth and influence of the Network over the last 15 years, and we would like to take this opportunity to thank her on behalf of the Network. Julia leaves a strong legacy for Kerry and the Network to build on.”
About Kerry Hood
Kerry is a Professor of Trials and Dean of Research & Innovation for the College of Biomedical & Life Sciences at Cardiff University. She is a Senior Research Leader and mentor for Health & Care Research Wales.
She has a degree and PhD in Statistics and spent the first part of her career focussed on research in primary care and then in 2006 established the South East Wales Trials Unit and started to develop a broader research portfolio. In 2015 she was appointed to lead the merger of three CTUs at Cardiff and created the Centre for Trial Research and was the Director until 2023.
She is a Fellow and Chartered Statistician of the Royal Statistical Society and the Higher Education Academy and a member of the Society for Academic Primary Care and the British Society for Antimicrobial Chemotherapy.
About the Network
The UKCRC Registered CTU Network is a network of 51 Clinical Trials Units that have been assessed against key criteria by an independent international panel of experts in clinical trials research. Registration acts as a hallmark of quality, excellence and integrity and provides assurance to the standard of studies undertaken by Registered units. Our vision is for Registered Clinical Trials Units to be recognised as world leaders in the design and delivery of high-quality, effective, efficient, and sustainable clinical trials research. Through the creation of working groups, forums, and learning opportunities for member CTUs and their staff, and by engaging with key stakeholders including regulators and funders, we aim to: Develop and share best practice across our members: Improve the promotion of Registered Clinical Trials Units and to be a strong voice for Registered Clinical Trials Units
Recent discussions amongst statisticians from Registered CTUs seem to indicate that there is a gap in training and development opportunities for statisticians looking to move into senior roles within academic clinical research. This piece explores some of the common practices across the Network and discusses what else could be done.
At the Spring 2023 Statistics National Meeting delegates heard about a project being undertaken by the ICR-CTSU to identify training opportunities for trial statisticians at all stages of their careers. As part of the session, Fay Cafferty (The ICR-CTSU) noted that although learning and development for early career statisticians was generally well provided for, finding options for those looking to move into more senior roles was more challenging.
Delegates at the meeting, who were drawn from units across the UK and who were at varying stages of their career, then had the opportunity to share their personal experiences and discuss the practices at their unit.
As expected, there was a range of approaches in the provision of learning and development opportunities. Some units had formal training in place for new starters, either individually or in teams, others provided more informal on-the-job training by experience. Generally, training was better developed for more junior staff.
Shadowing and mentoring
Documented shadowing or working in parallel with more senior colleagues as part of training was discussed, though this depended on there being sufficient time available for both parties. Given typical hybrid working arrangements, it was recommended that agreeing core or overlapping days could facilitate shadowing more effectively. Some commented that it was more difficult to seek help when working remotely. Others suggested that, in large units, it could be difficult for junior colleagues to know where various types of expertise sat. Mentoring from a senior statistician at another CTU could be beneficial, allowing more open discussion and guidance on career development.
Postgraduate study
Various units allowed day-release for junior staff to undertake an MSc (in person or at distance) or support fellowships e.g. at pre-doctoral level, some had a requirement for their staff to hold a PhD in order to progress; others allowed progression based on having accrued several years’ experience working in trials. A few units supported candidates working towards a PhD-by-publication. At least two Units recruited to ‘trainee statistician’ roles. Progression to a more senior role was often via a postdoctoral research fellowship. Many units liked to grow their own statisticians from postgraduate study all the way through to becoming experienced trial statisticians. Noting that it can often be very difficult to recruit more experienced statisticians externally.
Skills development
A good learning opportunity for junior colleagues could be to validate methods used e.g., a more junior statistician tries replicating a sample size calculation that was performed by a more senior colleague. Aside from learning methods and trial processes, it was regarded as important for staff to develop their soft skills, e.g. by attending generic courses provided by the host institution on writing, leadership, and communication skills. Teaching was highlighted as an excellent way to develop communication skills. Further, those working in applied research could benefit from reading up on relevant clinical areas to increase understanding and facilitate communication with investigators. Observing a funding panel meeting was suggested as a good development opportunity. The use of checklists for on-the-job training, or a handbook, was found to be useful by some.
Training resources
Several units had training presentations available or encouraged staff to attend free webinars. Training materials produced during the pandemic were cited as a good resource for staff. Others suggested that, as a Network, we could share such resources between us e.g. recording a training session and then making the recording available to Network colleagues. It was suggested that it would be worth exploring costing training activities into grant applications. In general, it was thought important that all statisticians in a Unit should have access to the same training opportunities. One person commented on potential inequality of training opportunity between jobbing statisticians and personnel on fellowships. Network resources for training include GCP for Statisticians (in development) and guidance on the validation of statistical programming.
Career progression
In one unit, career progression was contingent on being a co-applicant on at least one successful grant application. In terms of grant applications, a junior statistician might work with a more senior colleague on an application, with both going on as co-applicants. Setting up knowledge sharing or working groups was also suggested. It was agreed that it would be worthwhile to lobby funders for more money for methodological support. Concerns were voiced about the loss of core NIHR funding for CTUs, potentially reducing funds available for training and development.
What next?
The Statistics Operations Group are considering developing a forum for units to share internally created training and development materials and/or signpost to external options. They are particularly keen to identify resources for those looking to move on to a more senior role.
If you would be willing to share resources with colleagues at other Network CTUs please contact the Secretariat (regctus@leeds.ac.uk).
Get in touch
If you have any questions about the site, please feel free to contact us. We are always looking for ways to better serve our members - YOU are important to us!
