Upcoming Events

Co-hosted with Irish Critical Care Clinical Trials Network

Location: Museum of Literature Ireland, Dublin

General admission: €200. To register, CLICK HERE

Contact us at hrb-tmrn@universityofgalway.ie to express interest in attending

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This webinar will introduce process evaluations. Process evaluations are often integrated with outcome evaluations (e.g. RCTs). They help to explain why an intervention was or was not effective by exploring: 1) If it activated the intended causal pathways; 2) If it was implemented as planned; 3) If it was acceptable to delivery agents and participants; and 4) If the wider delivery context was supportive or inhibitive. The webinar will describe key process evaluation concepts, frameworks and guidance, alongside common methods that are used to undertake them.

Speaker:

Professor Rhiannon Evans is based at DECIPHer, which is a public health research centre of excellence at Cardiff University. The centre is focused on the development, implementation, evaluation and adaptation of interventions. Professor Evans is the Deputy Director and lead for health inequalities research. She is Deputy Director of the NIHR Public Health Research Systematic Reviews Team, which undertakes evidence syntheses to inform NIHR funding priorities.  Rhiannon is Co-Investigator on the newly established Wales National Centre for Suicide Prevention and Self-harm and the NIHR Rhondda Cynon Taf Health Determinants Research Collaboration (HDRC). Her methodological expertise in in complex systems informed systematic reviews, intervention development and adaptation, and process evaluations. She was Principal Investigator on MRC-NIHR funded ADAPT guidance to support the adaptation of interventions for new contexts.

Interactive One-Day Workshop

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Participants can anticipate an informative and practical event that will equipping them with the tools to calculate sample size and assess study power, and an understanding that will help them navigate the intricacies of clinical trial planning and analysis.

A comprehensive overview of key steps in the process will be discussed, rationale explained, and several worked examples provided. Attendees will gain insights into techniques for obtaining or estimating effect size, a primary determinant of a required sample size. PI experience, common pitfalls and challenges will be discussed in a panel discussion.

Study day will end with a Statistics Clinic – you can bring your own problem to be discussed with a statistician (please email brief description in advance).

This Study Day is tailored for clinicians, students, researchers, and professionals involved in clinical trial design, conduct and analysis, with no or intermediate level of experience with statistical planning.

Contact us at hrb-tmrn@universityofgalway.ie for more information

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The Trialist Series is an in-person lunchtime lecture series designed to enhance the skillset of Principal Investigators and Industry stakeholders. This short session focuses on an essential component of trial development and study design. These events are led by experts in the field. Join us to advance your trial leadership skills and enhance the quality and impact of your research.

This series is hosted by the Institute for Clinical Trials and the HRB-TMRN. CPD points will be available for attendees.

The session will run from 12:30pm to 2:00pm in the Large Lecture Theatre, Clinical Science Institute, University of Galway

Contact us at hrb-tmrn@universityofgalway.ie for more information

Co-hosted with Irish Critical Care Clinical Trials Network

Location: Museum of Literature Ireland, Dublin

General admission: €200. To register, CLICK HERE

Contact us at hrb-tmrn@universityofgalway.ie if you have any questions

Click here to register

The adoption of complex innovative clinical trial designs has steadily increased in recent years. These trial designs incorporate one or more unconventional features intended to improve efficiency. The motivation for these designs may not be difficult to follow, but their set-up and implementation is usually more challenging. Statistical properties of these designs can also be difficult to compute. Clinical trial simulation (CTS) can be conducted to contribute to a better understanding of the value of unconventional features before implementing the design in an actual clinical trial. This talk introduces a new framework, called OCTAVE, for outlining the details of CTS. Key computational components, such as data generation strategies and code validation procedures will also be discussed. The target audience includes trial statisticians who are involved in designing and analysing clinical trials.

Speaker:

Dr Kim May Lee is a Research Fellow in the Department of Biostatistics and Health Informatics at King’s College London. Her work focuses on the design and analysis of clinical trials, with expertise in adaptive and innovative trial methodologies, including platform trials, adaptive randomization, and methods for handling heterogeneity and missing data. Dr Lee holds a PhD in Statistics from the University of Southampton and has previously worked at the MRC Biostatistics Unit at the University of Cambridge and the PCTU at Queen Mary University of London. She works closely with clinical researchers, providing methodological support for applied trials. Her research aims to improve the efficiency, rigour, and interpretability of modern clinical studies.

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In adaptive clinical trials, the conventional end-of-trial point estimate of a treatment effect is prone to bias, that is, a systematic tendency to deviate from its true value. While much of the methodological developments on adaptive designs have tended to focus on control of type I error rates and power considerations, in contrast the question of biased estimation has received relatively less attention. Recent regulatory guidance, such as ICH E20, has highlighted the need to use adjusted estimators for adaptive designs to address these issues. In this webinar, we will present an overview of methods for unbiased estimation for adaptive designs. Starting with a systematic review of the methodological literature, we will then focus on the two-stage trial setting, where a variety of minimum variance unbiased estimators have been proposed. We will conclude with some proposed guidelines for researchers around the choice of estimators and the reporting of estimates following an adaptive design.

Speaker:

David Robertson is an Assistant Research Professor at the MRC Biostatistics Unit, University of Cambridge, where he has been based since 2013. His research focuses on the development of novel methodology for the design and analysis of adaptive clinical trials. From 2018 – 2021, David held a Biometrika Trust Research Fellowship, which explored questions around error rate control for clinical trial designs that test multiple hypotheses simultaneously. His current main areas of research include estimation after adaptive designs, response-adaptive randomisation in clinical trials and multiple hypothesis testing.

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1. Optimising Recruitment and Retention in Clinical Trials, Dr Adwoa Parker, Associate Professor, University of York
2. Investigating strategies to optimise trial recruitment – an overview of Studies Within a Trial (SWATS) –  Catherine Arundel, Research Fellow, University of York

A full programme with speakers, talks and titles will be available shortly.

This research seminar was supported by an award made through the HRB CE Scheme 2025 (Award No. CES-2025-054) and hosted by UCD CRC and RDCTN in collaboration with HRB-TMRN, ICCCTN and ID-CTNI

Contact us at hrb-tmrn@universityofgalway.ie for more informatio

Please be aware that by attending this event you enter an area where photography, audio, and video recording may occur. By entering the event premises, you consent to photography, audio recording, video recording and its/their release, publication, exhibition, or reproduction to be used for news, web casts, promotional purposes, advertising, inclusion on websites, social media, or any other purpose.

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Recruitment and retention challenges remain a major threat to the success, efficiency, and value of clinical trials. While Studies Within A Trial (SWATs) offer a robust way to evaluate trial process interventions, their uptake has been limited by a lack of practical, ready-to-use resources.

This webinar will present the PRESS (Protocols and Resources for Priority Recruitment and Retention SWATs) project, which has co-developed with PPI partners, a comprehensive, openly accessible suite of protocols and supporting materials to enable trial teams to embed high-priority recruitment and retention SWATs with confidence. Attendees will be introduced to the PRESS Master SWAT Protocol Template, a set of randomised recruitment and retention SWAT protocols, co-produced PPI-focused SWATs, and accompanying guidance on ethics, statistical analysis, health economics, accessibility, and funding applications.

The webinar will focus on how these resources can be used in practice to reduce barriers to SWAT adoption, accelerate evidence generation, and enhance trial efficiency.

Speaker:

Professor Frances Shiely is Professor of Clinical Trials at University College Cork (UCC), Director of Education at the HRB Clinical Research Facility, UCC, and UCC lead for the HRB Trials Methodology Research Network. Her work focuses on clinical trials methodology, particularly communication and the use of Studies Within A Trial (SWATs) to improve recruitment, retention, and trial efficiency, alongside the development of training and education for trialists and patient and public partners. She has led or co-led over €20 million in competitive research funding and is Founder and Director of Ireland’s MSc in Clinical Trials.

Dr Adwoa Parker is a UK National Institute for Health and Care Research (NIHR) Advanced Fellow and Associate Professor at the University of York, UK. As a trialist and trial methodologist, she leads the Trial Forge Studies Within A Trial (SWATs) Centre at the University of York. SWATs are self-contained studies embedded within host randomised trials, designed to generate robust evidence that improves the efficiency, design, and delivery of future clinical research. Adwoa’s 10-year NIHR Advanced Fellowship, ‘IMPLEMENT SWATs’, focuses on the intersection of implementation science and methodology to enhance evidence-informed participant recruitment and retention. Beyond her primary focus on trial methodology, her research interests encompass mental health trials, Patient and Public Involvement (PPI), and the advancement of Equity, Diversity, and Inclusion (EDI) within clinical research. Adwoa is also the Fellowship Lead for the NIHR Research Support Service (RSS), delivered by University of York and Partners

To register, click here

Location: The ICC, Birmingham

Dates: 14th – 17th September 2026

ICTMC is the leading international platform for researchers and practitioners to present the very latest in trials methodology. The meeting also offers valuable networking and training opportunities, with over 1,200 delegates from 32 countries attending in 2024. The 2026 conference will take place in the vibrant and diverse city of Birmingham. As the UK’s dynamic second city, Birmingham is steeped in innovation and culture, particularly its legendary musical roots. Known worldwide for its manufacturing heritage, Birmingham is also one of the greenest cities in the UK, with its urban parks and canals loved by many for leisurely walks and scenic views.

To visit the website, click here