Trials Methodology Research
Over the last 5 years, methodologists in the Centre have been responsible for disseminating a substantial number of methodological publications with an average of over 20 methodological papers published per year.
This body of work encompasses the breadth and depth of methodological work across both quantitative and qualitative fields as well as from professional teams within the centre covering themed areas of novel methods, trial conduct and efficiency. The development and sharing of knowledge is core to our mission and every team within the centre has been part of this combined effort from trial and data management, through to quality assurance and information services.
We pride ourselves in being an academic trial unit and recent methodological publications from across our teams demonstrate our commitment to this purpose in everything we do. Alongside our methodological success, sits clear evidence of professional development. Our methodological expertise has grown significantly over time and several members of our methods teams have achieved academic promotion and/or doctorates, as well as career development via doctoral and advanced fellowships.
Adaptive designs
Over the past five years, the Centre for Trials Research has established itself as a UK leader in the design, delivery, and methodological advancement of adaptive clinical trials. These innovative designs introduce planned flexibility into clinical trial protocols, allowing key elements such as sample size or treatment allocation - to be modified in response to interim findings without compromising scientific integrity.
Adaptive trials can be more efficient than conventional designs, accelerating access to effective treatments, reducing unnecessary patient exposure, and improving value for public funders. Their complexity, however, requires dedicated expertise and infrastructure - both of which the Centre has actively cultivated.
Notably, Dr Philip Pallmann, Principal Research Fellow in Statistics at the Centre, has played a pivotal role in shaping national and international guidance on adaptive methodology. He co-led the development of PANDA, a UK-wide self-learning platform for adaptive trial designs, and contributed to the ACE-CONSORT and SPIRIT-DEFINE reporting checklists. Through this work and his leadership of the MRC-NIHR Adaptive Designs Working Group he has directly influenced the uptake of adaptive methods across the UK, and enhanced the quality of adaptive trial design and reporting globally.
This methodological leadership is already translating into impact. The Centre is delivering several live adaptive trials across oncology, infectious disease, and digital health, applying Bayesian and frequentist approaches to real-world challenges. These studies illustrate how Welsh Government investment is not only delivering high-quality research but is creating a national environment where methodological excellence thrives.
By embedding adaptive trial design within its operations, the Centre is positioning Wales as a preferred destination for Chief Investigators and industry collaborators seeking efficient, flexible, and world-leading clinical trials.
Capacity Building: Internships and Student Placements
Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts.
Our Centre has significantly expanded its qualitative research capacity and expertise over the last five years, enhancing the depth, impact, and relevance of its trials and broader research portfolio. Qualitative methods have increasingly been integrated into trial designs, ensuring patient voices and lived experiences meaningfully shape research outcomes.
One key area of growth has been the embedding of qualitative researchers within multidisciplinary trial teams from inception through to dissemination. By collaborating directly with clinicians, statisticians, and patient representatives, our qualitative experts have enriched the research design and interpretation process. This integrated approach has informed the development of research questions, refined interventions, and ensured trial outcomes are genuinely aligned with patient and clinician priorities.
A standout example of this approach is our qualitative work within complex interventions, such as the DELIVER-MS and PRIMUS studies in multiple sclerosis. Here, patient and clinician perspectives were captured through qualitative interviews, enabling more patient-centred measurement strategies and enhancing the
applicability and transferability of findings. Similar integrated qualitative work has taken place across diverse clinical areas including mental health, oncology, and palliative care.
Our team have led in methodological innovation, for example, new methods for conducting remote qualitative interviews, developed rapidly in response to the COVID-19 pandemic, have enabled continued patient involvement and provided lasting lessons on conducting flexible, inclusive research. This has further cemented the Centre’s position as a leader in integrating contemporary qualitative research practice into trials.
Going forward, our investment in qualitative research continues to highlight the added value of listening deeply and systematically to patients, healthcare professionals, and wider stakeholders. This patient-centred ethos aligns closely with Welsh Government priorities, maximising the value and impact of investment in health and care research, and positioning the Centre as an attractive environment for current and future Chief Investigators keen to incorporate robust qualitative methods into their studies.
Building capacity in the methods of patient reported outcome measures
Funder: Health and Care Research Wales
The SOCRATES study involved the development of a patient reported outcome measure for Rheumatoid arthritis. Publications resulting from the study include a systematic review, with two further manuscripts in submission with Rheumatology. The results have been presented at national and international methodology and rheumatology conference, including oral presentation at the International Society of Quality of Life Research (ISOQOL) Conference in 2022 and a poster at the American College of Rheumatology Convergence in 2023. SOCRATES was completed as part of a Health and Care Research Wales Doctoral fellowship by Tim Pickles a research fellow in statistics in CTR. He successfully completed his viva in April 2024 and was awarded a Health and Care Research Wales Next Steps Award (PLAN-HERACLES). This has led to an application to MRC Career Development Award to further the research of SOCRATES and PLAN-HERACLES. Tim has been successful in obtaining funding for patient-reported outcome measure research in grief and dermatology and has also been a co-applicant on bids in vision, trauma, shared decision making and pre-Rheumatoid Arthritis.
Tim now supervises two PhD students in topics related to vision and physiotherapy. Through the Health and Care Research Wales Faculty, Tim attended leadership training with Leaderful Action and Methodological Innovation In Public Health Intervention Science: Development, Evaluation And Adaptation provided by DECIPHer. Tim attended multiple training courses with the funding available for the SOCRATES study and is now lecturing at the University of Copenhagen and the University of Aarhus on psychometrics and patient- reported outcome measure research. Tim has also engaged with the National Rheumatoid Arthritis Society (NRAS), Outcome Measures in Rheumatology (OMERACT) and NHS Wales Executive National Strategic Clinical Network for Musculoskeletal Conditions, and is now a statistical reviewer for Rheumatology.
CONSULT Training: Pioneering Inclusivity in Research
Funder: Health and Care Research Wales
The CONSULT Training Programme led by Dr Vicky Shepherd has emerged as a cornerstone in advancing inclusive research practices. This initiative is designed to equip researchers with the skills and knowledge they need to include adults lacking capacity to consent in clinical trials. The training aligns with our Centre’s commitment to diversity and inclusivity, addressing a critical gap in trial design and delivery. The project was supported by a Lay Advisory Group and a team of researchers with expertise in this area.
The CONSULT training was launched at a webinar which included researchers, health professionals, and ethics committee members, showcasing its broad appeal and impact. Supported by our Communications Team, the webinar provided a platform for sharing expertise and practical solutions to overcome barriers in inclusive research. As one participant noted, “I feel less daunted by the prospect of involving people with impaired capacity in research activities.” Another attendee pledged immediate action, stating, “I’m planning to distribute the training to my team to better inform future studies.”
The programme’s free, self-paced, series of e-learning modules has been widely praised for its accessibility and practical application, with participants emphasising its value in fostering more equitable research environments. The content is based on the CONSULT research programme, funded by Health and Care Research Wales, and was informed by a survey to identify researchers’ training needs. The e-learning modules cover the legal and ethical frameworks governing trials involving adults with impaired capacity to consent, as well as methodological considerations. It includes case studies, videos, and links to resources
help researchers understand how to design and conduct clinical trials involving this under- served group. The training complements the Centre’s overarching mission to generate robust evidence that improves public health and social care outcomes.
CONSULT exemplifies our dedication to producing high-quality research that is inclusive and impactful. By addressing underrepresentation in clinical trials, we ensure that the benefits of research extend to all members of society, aligning with our values of equity and innovation.
