Upcoming Events

This course aims to provide an introduction to the challenges of recruiting people to randomised controlled trials (RCTs) and strategies to address these. The course draws on evidence generated by the QuinteT research programme, which specialises in optimising recruitment to RCTs based on research conducted in over 70 trials to date. Course content and examples will be drawn primarily from trials set in secondary care hospital settings that span a range of medical specialities. This course aims to equip attendees with insight into the common sources of recruitment difficulty in RCTs and ways of mitigating or overcoming these.

“Felt it was a very comfortable, friendly atmosphere within the group. Extremely informative and well organised into manageable sections.” – Course feedback, June 2025

Our online courses are delivered by topic specialists within the Bristol Medical School and provide continued access to online learning materials and recordings for a further 5 months after the course.

Visit our website for more information and to find out about available discounts: https://www.bristol.ac.uk/medical-school-short-courses/

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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This research seminar is 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 information.

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

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

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.

Advances in data science including a commitment to reproducible science through open standards, data and source code have resulted in different ways of working within research. Trusted Research Environments are in many cases now the default pathway to accessing data, representing a step change in how data is accessed for research and introducing new challenges. The tutors on this course have been at the forefront of these developing approaches, both through applied research and the development of infrastructure. The University of Bristol (with the University of Edinburgh) run the UK Longitudinal Linkage Collaboration (UK LLC), a trusted research environment bringing together information from the longitudinal study volunteers with their routine records.

“As well as understanding what a TRE is and some of the governance considerations around using them, I’ve now got a greater appreciation of the amount of work involved in “data handling” projects and the time/effort required to successfully complete this kind of work” – Course feedback, March 2025

Our online courses are delivered by topic specialists within the Bristol Medical School and provide continued access to online learning materials and recordings for a further 5 months after the course.

Visit our website for more information and to find out about available discounts: https://www.bristol.ac.uk/medical-school-short-courses/

Collection of data is an essential aspect of most projects in many areas of health research, observational studies, qualitative work, and Randomised Controlled Trials. Many staff are tasked with deciding what, when and how data should be collected for their study. Collecting the right data is essential to answer the research question. This course will cover the basics of data collection in research studies, why it is important and tips on how to ensure data integrity. This course aims to explain the basics of data collection in research studies, why it is important and tips on how to ensure data integrity.

“Slick teaching sessions, good mix of lectures and interaction sessions.” – Course feedback, June 2025

Our online courses are delivered by topic specialists within the Bristol Medical School and provide continued access to online learning materials and recordings for a further 5 months after the course.

Visit our website for more information and to find out about available discounts: https://www.bristol.ac.uk/medical-school-short-courses/

Click here to register

Early-stage biotech companies face intense pressure to move quickly into the clinic, yet safety remains the most common source of critical findings, delays, and regulatory scrutiny in early trials. This webinar draws on practical experience supporting emerging sponsors and expands on themes from our white paper, Safety That Scales: Clinical Safety Strategies for Biotech Startups in Early Clinical Trials. We will demystify how drug safety operates in early-phase development, including the distinct roles of pharmacovigilance, medical monitoring, and risk management. Attendees will gain clarity on sponsor responsibilities, SAE and SUSAR reporting, safety governance models suitable for small organizations, and how to maintain effective CRO oversight. Through real-world case studies including first-in-human signal escalation and pre-inspection remediation we will highlight common pitfalls faced by academic spin-outs and first-time sponsors. Participants will leave with a practical safety readiness checklist and key questions leadership teams should be asking to build scalable, inspection-ready safety frameworks from day one.

Speaker:

Dr Susan Fitzpatrick is a Clinical Pharmacovigilance Consultant at Signal Pharma Experts, where she supports early-stage biotech and pharmaceutical companies in building scalable, inspection-ready clinical safety frameworks. With over 10 years of experience in preclinical and clinical development, she specializes in patient safety across first-in-human and later-phase trials. Susan has guided clinical programs from study start-up through close-out and regulatory submission, with expertise in SAE and adverse event management, safety data review, signal detection, risk mitigation, and preparation of key safety documents including Investigator’s Brochures and safety management plans. She also supports inspection readiness and serves as a subject matter expert during audits and regulatory inspections. She holds a BSc (Honours) in Pharmacology and a PhD in Medical Science from University College Dublin.

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This 90-minute workshop explores the ethical and practical challenges of including adults who lack capacity to consent in clinical trials. The session will be delivered by Dr Victoria Shepherd, Principal Research Fellow and registered nurse based in the Centre for Trials Research, Cardiff University who leads methodological research aimed at improving the inclusion of under-served populations in research, particularly in settings where traditional informed consent processes may be difficult.

Drawing on extensive experience in clinical trials and methodological research, the workshop will present learning from CONSULT, a NIHR Advanced Fellowship project, funded by Health and Care Research Wales that developed and tested a decision-support tool to help family members or legal representatives decide whether adults who lack the capacity to consent should take part in research. The session will also highlight current guidance, tools and methodological approaches developed to support researchers working with populations who may have impaired capacity to consent.

The workshop is suitable for PhD and postgraduate students, research staff and clinical trial recruiters, study principal investigators, and anyone with a broader interest in improving inclusion in clinical trials.

Date & Time

30th June, 10:00 – 11:30

Location

The Pavilion, University of Limerick

Speaker

Dr Victoria Shepherd, Cardiff University

Pragmatic Randomised Controlled Trials (RCTs) are the ‘gold standard’ test for evaluating whether a new intervention is better than an existing one and are routinely used in both real-world healthcare and public health settings. Academics working in the Bristol Trials Centre (BTC) and the University of Bristol (including those who are tutors on this course) have all been at the forefront of designing and implementing high quality pragmatic RCTs for this purpose. This course aims to provide an understanding of the essentials of designing, conducting and analysing pragmatic randomised controlled trials (RCTs). The course examines RCTs evaluating health and public health interventions in primary, secondary and community settings with individual and cluster randomised designs.

“The course was packed full of information and delivered by a range of presenters with varying experiences and expertise. The course provided insight on pragmatic RCTs as a whole and was insightful for providing a broad view of all considerations for RCTs” – Course feedback, May 2025

Our online courses are delivered by topic specialists within the Bristol Medical School and provide continued access to online learning materials and recordings for a further 5 months after the course.

Visit our website for more information and to find out about available discounts: https://www.bristol.ac.uk/medical-school-short-courses/

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.

The HRB-TMRN are also delighted to announce the award of a competitive bursary supporting attendance at the ICTMC 2026 Conference, recognising outstanding contribution and commitment to trials methodology research. Further details and full guidance is available here.

To visit the website, click here

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Speaker:

Professor Nichol is the Chair of Critical Care Medicine in University College Dublin and the Director of the Irish Critical Care Clinical Trials Network and Consultant in St Vincent’s University Hospital, Dublin.
He has been an investigator on peer reviewed grants worth over 65 million euros from Ireland, Europe, Australia, New Zealand and Canada. He has completed the hat trick of first author publications- in NEJM, Lancet and JAMA. Currently he is completing trials in the critically ill which will randomize over 20,000 patients in the next 5 years. He has academic interests in Pandemic Preparedness, Cardiac Arrest, Trauma and Mechanical Ventilation. He also has four kids and therefore has no hobbies and plays no sports, but he lives in hope of this improving.

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Speaker:

Prof. Thomas Jaki holds the Chair of Computational Statistics at the University of Regensburg and is also Professor of Statistics at the MRC Biostatistics Unit, University of Cambridge. His research focuses on statistical methodology for clinical trials, with particular emphasis on adaptive and efficient study designs that play a crucial role in medical practice. During the COVID-19 pandemic, Prof. Jaki was a key contributor to the RECOVERY Trial, one of the largest clinical studies worldwide investigating treatments for COVID-19. He earned his Master’s degree in Statistics at Johannes Kepler University Linz and completed his PhD in 2006 at the University of South Carolina. From 2008 to 2022, he served as Professor of Statistics at Lancaster University in the United Kingdom. Since 2020, he has been Professor at the University of Cambridge, and since 2022, Professor at the University of Regensburg. Prof. Jaki combines academic excellence with practice-oriented research and serves as a bridge between statistics and medicine.

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Speaker:

Professor Sally Hopewell‘s key areas of research expertise are in the design, conduct and transparent reporting of randomized trials and systematic reviews. She has published a number of research studies in these areas including the development of key reporting guidelines such as the CONSORT Statement and PRISMA for Abstracts. She joined the Oxford Clinical Trials Unit (OCTRU), at the University of Oxford, in February 2015, to take up a new position as Senior Research Fellow in Clinical Trials where she is involved in the design and delivery of a number of trials within the OCTRU portfolio. Previously, she worked at the Centre for Statistics in Medicine (2007 – 2015) on a MRC funded programme of research related to CONSORT and the conduct and reporting of clinical trials. She also worked, and continues to collaborate with, the Centre d’Epidemiologie Clinique (2012 – present), University Paris Descartes, on research activities related to the methodology of systematic reviews and randomized trials. She is currently running a trial targeting medical journals and evaluating the impact of a web-based tool to improve trial reporting. Sally has a particular interest in clinical trial registration, data sharing, reporting of clinical trial protocols, pilot trials and trials of non-pharmacological and complex interventions. She is an academic editor for PLoS ONE, sit on the editorial board for the journal Systematic Reviews and is also a member of the advisory board for Current Controlled Trials and the IDEAL Collaboration steering group.