CRP Bulletin - October 2025
CRP Bulletin - October 2025
Highlights in this bulletin
Please select the links below to navigate to the content you want to see. Alternatively you can scroll down to read all the content included in this bulletin:
Autumn is well and truly here now. We hope you enjoyed the extra hour in bed as the clocks changed back to Greenwich Mean Time.
Scroll down to read all about the CRP updates from the last quarter, including the launch of a new CRP survey, events, CRP stories, CRP Publications, a celebration of CRP colleagues and an update about the new UK Clinical Trials Legislation.
We would love to hear more from you so if you have any stories or information you would like to share, please contact your local CRP Engagement Lead.
The editorial board for this quarter's bulletin are:
Ruth Johns (CRP, West Midlands RRDN )
Rachel Evans (Senior CRP, West Midlands RRDN)
Claire Hall (Communications Manager, West Midlands RRDN)
Maxine Berry (Project Support Manager, Leeds CRF)
Deirdre Brooking (Workforce & People Senior Manager, North London RRDN)
Jo Sawyer (Head of Research, Shrewsbury and Telford Hospital NHS Trust)
Sarah Essex (Cancer Research Team Lead, North East and North Cumbria RRDN)
Rhianne Bostock (CRP, Nottinghamshire Healthcare NHS Foundation Trust)
Emma Douglas (Genetics CRP at Birmingham Women’s and Children’s NHS Foundation Trust )
Steph Kings-Jones (RDN CC GCP National Lead / Learning & Development Facilitator, East Midlands RRDN)
We will send a link to the Clinical Research Practitioner (CRP) 2025 Survey in a separate bulletin soon. The survey has been developed to:
Scope identity within the current CRP occupational groups with respect to; academic background, level of research / clinical experience and areas of work
Support the development of a CRP community of practice, establish focused content for CRP newsletter/communications and professional development opportunities
Establish a benchmark and baseline of where this occupational group is currently so we can measure the impact of development over time, relating this to, significant system, organisational and societal changes linked to embedding of health and care research across the NHS and wider care settings.
Completing the survey is optional, but the more CRPs who do, the more representative and accurate our data will be. We would appreciate it if you could prioritise completion of the survey if you are willing to do so. You may also receive notification of this survey via additional distribution channels. Development and distribution of this survey is supported by the NIHR Research Delivery Network and the Academy for Healthcare Science as part of joint ongoing commitments to enabling development for CRPs.
Research & Development Forum Conference May 2025 Poster Presentation: Creating a diverse clinical research workforce: the role of the CRP (Jo Sawyer, Ruth Johns & Rachel Evans)
This poster sets out the expectations for developing CRPs as a recognised profession in the future. We feel passionately about CRPs being recognised as the highly trained and specialist group of professionals that we are. It was important to raise awareness on this national platform of not only the need for the CRP to come together to identify as a profession, but also to talk about next steps.
At the next R&D Forum conference our aspirations would be to host a workshop raising awareness and further developing the identity of the CRP profession within our changing research ecosystem.
It is vital that we continue the momentum of CRPs as a profession and continue to represent the voices of both active CRPs on the registry and CRPs who are now in leadership positions.
Outcome from the Clinical Research Practitioner Employers Engagement Event held on 14 March 2025
Deirdre Brooking, Workforce and People Senior Manager North London RRDN
The April 2025 edition of the Clinical Research Practitioner (CRP) bulletin featured a report on the inaugural CRP Employers Engagement Event. This collaborative initiative was undertaken by University College London Hospitals NHS Foundation Trust (UCLH) and Guy's and St Thomas' NHS Foundation Trust (GSTT), with support from the North London and South London RRDNs.
The primary objective of the event was to assist organisations in the investment, development, and retention of the vital Research Delivery Workforce. The CRP brochure was introduced on the day, serving as a comprehensive guide for CRPs and managers to facilitate recruitment and professional development. During the event, delegates submitted questions, to which a panel of experts from NHS Trusts and the National Institute for Health and Care Research (NIHR) formulated comprehensive responses. These responses have been compiled for your reference in this document.
It is anticipated that some of these answers will be refined as the UK research and workforce landscape and opportunities evolve.
CRPs in action: Breast Cancer Research!
By Risna Haq and Saba Kouser, Clinical Research Practitioners
In a bid to reach underserved populations in the West Midlands, our CRPs were recently tasked with running research on the breast screening vans in supermarket car parks. It was a nationwide study called PROSPECTS, a randomised controlled trial which compared the cost and effectiveness of 3D versus 2D (standard care) mammograms. The 3D technology is thought to be more accurate and able to detect breast cancer at a much earlier stage, meaning it is better for women’s health, reduces treatment costs, and leads to fewer call backs due to the improved accuracy.
The challenge was running this research within a 6-minute appointment window in a confined space alongside the radiographers. The study required that consent be received ahead of the scan, meaning patients would have to consent before they went in for their mammograms. To overcome this, we arranged with the screening service to send patient information sheets out with the appointment letters and then asked if the women wanted to hear more about the trial as soon as they came for their appointment.
There were many barriers to this study, including language, tight spaces and lone working time management. Whilst the radiographers were mostly accommodating, it was frustrating not being able to see all the patients in the time frame allocated. However, we worked around these barriers. Our CRP workforce includes speakers of Punjabi and Hindi, allowing us to reach that underserved community of Asian women. Our willingness to squeeze into the little kitchen next to the kettle gave us the privacy we needed to conduct the consent process. Our flexibility and communication with the radiographers allowed us to maximise the number of patients we could see in one day.
The results from this study will potentially shape breast cancer screening in the future and look to detect small breast cancer sooner. We collectively recruited over 9,000 patients across Birmingham (100,000 nationally). This was a massive achievement, and we are proud of problem solving and inclusive recruitment!
Names in order back row left to right
Zoe Pilsworth (Senior Research Nurse), Rebecca Grenfell (Clinical Research Practitioner), Amy Orme (Research Nurse) Libby Geeves (Research Nurse) Saba Kouser (Clinical Research Practitioner) Lavinia Henry (Research Midwife)
Sitting on the floor left to right
Risna Haq (Clinical Research Practitioner) Maya Tung Ande (Clinical Research Practitioner) Stories
Ensuring Success in Early-Phase Oncology Clinical Trials: Insights from a Clinical Research Practitioner
George Borley, Clinical Research Practitioner, Guy’s & St Thomas’ NHS Foundation Trust
Early-phase oncology clinical trials, often referred to as Phase I and Phase II trials, are critical for evaluating new cancer treatments. These trials aim to determine the safety, optimal dose, and initial efficacy of investigational therapies. As a clinical research practitioner, several factors contribute to the success of these trials, ensuring they are both scientifically sound and ethically responsible.
1. Clear Research Objectives and Endpoints
In early-phase trials, the primary goal is to assess safety and dosage, while secondary goals may include preliminary efficacy and biomarker identification. Defining these objectives early on helps structure the trial, ensuring that endpoints such as dose-limiting toxicities (DLTs) and initial signs of efficacy are clearly outlined. Well-designed objectives guide the research process and provide valuable information for future phases.
2. Rigorous Study Design
Study design in early-phase oncology trials is pivotal. A robust design includes clear inclusion and exclusion criteria, ensuring that participants have the characteristics needed to evaluate the investigational treatment effectively. For example, careful selection of patient populations based on cancer types and prior treatments is critical. The use of dose-escalation studies in Phase I, where different doses of a drug are tested to identify the maximum tolerated dose, ensures that safety is a priority, with interim analyses to make necessary adjustments.
3. Patient Recruitment and Retention
Patient recruitment is often one of the most challenging aspects of early-phase oncology trials. These trials typically involve patients with advanced cancer who may have limited treatment options. It’s essential to communicate the potential benefits and risks of participating in the trial clearly. Additionally, retention strategies, such as consistent follow-up care, managing side effects, and providing psychological support, help ensure that participants remain in the study, providing reliable data.
4. Effective Data Collection and Monitoring
Early-phase oncology trials generate complex data, including safety metrics and pharmacokinetic profiles. Timely and accurate data collection is critical for analysing the safety and efficacy of the investigational treatment. Real-time data capture systems and effective monitoring ensure that adverse events are quickly identified and managed, maintaining patient safety throughout the trial. Data safety monitoring boards (DSMBs) play a vital role in overseeing patient safety, ensuring that any unforeseen risks are swiftly addressed.
5. Collaborative Team Approach
Success in early-phase oncology trials requires a multidisciplinary approach. Oncologists, clinical research coordinators, pharmacists, data managers, and regulatory experts must work seamlessly together.
Each team member plays an essential role, from patient care and safety management to regulatory compliance and data analysis. A well co-ordinated team ensures that the trial progresses efficiently and that any challenges are addressed promptly.
6. Adherence to Ethical and Regulatory Standards
Ethical considerations are paramount, especially in early-phase trials where patients may be exposed to novel, unproven treatments. Obtaining informed consent and ensuring that participants fully understand the risks and potential benefits are fundamental. Additionally, compliance with regulatory guidelines such as Good Clinical Practice (GCP) ensures that the trial is conducted ethically, legally, and safely.
7. Real-time Adaptation
Early-phase oncology trials are inherently uncertain, with unexpected outcomes or side effects often emerging. The ability to adapt in real-time is crucial. For example, adjusting the dose-escalation plan or modifying inclusion criteria based on interim results can optimise the trial and ensure that patients are not exposed to unnecessary risks.
Conclusion
The success of early-phase oncology clinical trials hinges on careful planning, collaboration, and a commitment to patient safety. By focusing on clear objectives, a rigorous study design, effective recruitment, and real-time data monitoring, clinical research practitioners can help ensure that these trials not only meet their endpoints but also contribute valuable insights into the development of innovative cancer treatments. Each successful trial paves the way for future research, ultimately improving outcomes for cancer patients worldwide.
Clinician Researcher Credentials Framework Bursaries
Deirdre Brooking, Workforce & People Senior Manager, North London Regional Research Delivery Network
Congratulations to the successful candidates from the recent round of applications for the Clinician Researcher Credentials Framework. Indicated here are the number of applicants from each profession awarded a bursary, and in the smaller table to right, the percentage of successful applications from each profession.
It is great to see that 11 of our AHCS-registered CRP peers who have been successful in their applications.
The Clinician Researcher Credentials Framework is a national framework of masters level qualifications. These courses aim to give students the skills and confidence to lead and support clinical research studies. Further information about this are available here.
Multicentre audit reviewing reporting and management of patients with incidentally identified structural aberrations involving high actionability cancer susceptibility genes
Emma Douglas, Genetics Clinical Research Practitioner at Birmingham Women’s and Children’s NHS Foundation Trust, would like to share a recent publication that came from her involvement in the Genetics Research and Audit Collaborative (GRAC). GRAC is a group of early career researchers with representatives from Genomic Medicine Centres across the UK who conduct audits, service development and research projects.
The group’s cycle of activities includes inviting project proposals from members, reviewing and feedback on project proposals by an advisory board of clinical academics, presenting projects to the group, and voting on which projects to take forward. Once a project has been selected, the group aims to collect data from across the UK, and results are then shared through posters, publications or presentations.
Aim: A structural aberration with secondary implications (SASIs) involving a cancer susceptibility gene is identified on chromosome microarray in approximately 0.6% tests performed on index cases. Identifying a SASI involving a high actionability cancer susceptibility gene (HA-CSG), has important genetic counselling and management implications for the individual and families.
A UK working group has published recommendations for laboratories reporting SASIs involving HA-CSG. This study aims to evaluate whether these recommendations are reflected in current UK practice.
Congratulations to Charlie Piercy, Lead Clinical Research Practitioner at Royal
Surrey NHS Foundation Trust, who recently published a systematic review in the European Journal of Vascular Medicine. The paper summarises all the current literature on techniques, methodology, and safety of endothelial cell biopsy, a growing area of interest in translational vascular research.
The findings have played a key role in shaping the design of JEDI-1 and JEDI-
2, two clinical studies currently running at Royal Surrey that explore vascular
dysfunction in patients with sepsis.
Charlie was also invited to speak at Pint of Science 2025 - the international science festival that brings cutting-edge research into local pubs and cafes, aiming to make science accessible and engaging for everyone.
Pint of Science was founded to bridge the gap between researchers and the public, offering an informal space for people to hear about the latest scientific developments directly from the experts. Events take place across the UK and around the world, creating opportunities for meaningful dialogue between scientists and society.
Charlie’s talk, titled “The Mystery of Sepsis,” explored the complex biology of sepsis and highlighted the pioneering research being carried out at Royal Surrey NHS Foundation Trust. Charlie’s research, a joint effort between the hospital and the University of Surrey, showcased the power of collaboration in driving clinical research forward. The session was well attended by over 50 members of the public, who engaged with enthusiasm and curiosity. The talk sparked lively discussion and helped raise awareness about the realities of sepsis and the importance of ongoing research. A brilliant example of how we can make science accessible, relevant, and impactful for the community we serve.
by Stephanie Kings-Jones RDN GCP National Lead, Learning & Development Facilitator, East Midlands Regional Research Delivery Network
New regulations for running clinical trials in the UK will take full effect from 28th April 2026. This is the most significant update to UK clinical trials regulation in 2 decades – with the aim of strengthening patient safety, accelerating approvals, enabling innovation and helping more people benefit from taking part in vital research.
Please watch this Overview of changes in UK Clinical Trials legislation 6 minute video from Stephanie Kings-Jones for an overview of the changes.
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