Upcoming Events

A HRB-Trials Methodology Research Network Symposium hosted by the ICC-CTN
Location: Smock Alley Theatre, Templebar, Dublin

Date: 8th June 2026

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CPD accredited: A total of  6.0 credits have been assigned to this event.

Join us at Smock Alley Theatre on Monday, 8 June 2026 for the 10th Annual HRB-TMRN Trials Methodology Symposium, exploring how globally designed clinical trials can deliver meaningful impact at a local level.

Under the theme “Making Global Care Local: Innovations & Collaboration in Clinical Trials,” this year’s symposium brings together international leaders, early career researchers, and PPI contributors to examine the future of platform trials, the operational realities of complex international study designs, and the partnerships that make global trials work on the ground.

Hosted by HRB-TMRN in collaboration with UCD and in association with ICC-CTN, the day features a keynote from Prof. John Marshall, four themed sessions, panel discussions, and a dedicated spotlight on early career researchers. Whether you’re a trialist, methodologist, clinician, PhD student, or PPI partner, this symposium offers a full day of insight, dialogue, and connection.

09:00–09:20 — Registration & Tea/Coffee

09:20-09:25 – Opening Address – Ms Oonagh Ward, Health Research Board

09:25–10:00 — KEYNOTE ADDRESS

The Future of Platform Trials: global trends, efficiencies, and emergent trial designs – Prof. John Marshall, University of Toronto

Session 1: Lessons From Global Clinical Trials (Chair: Prof. John Laffey, University of Galway)

10:00–10:20: Barriers and solutions to international platform trials – Dr. Danny McAuley, Queens University Belfast

10:20–10:40: Selected methodological considerations from platform trials – Dr. Neill Adhikari, University of Toronto

10:40–11:00: Health economics of international platform trials – Dr. Lisa Higgins, Monash University

Panel Discussion: Implementing Platform Trials Locally 

11:00–12:00: Integrating global protocols into national systems – overcoming logistical and regulatory barriers. Q&A

12:00–13:00: Lunch & Networking

Session 2: Spotlight on Early Career Researchers (ECR) (Chair: Dr Aisling McMahon, Mater Hospital)

13:00–13:15: The PANTHER trial early career researcher programme – Dr. Kiran Reddy, Queen’s University Belfast

13:15–13:30: STERO-CARE – Dr. Peter McGuigan, Royal Victoria Hospital, Belfast

13:30–14:10: HRB-TMRN PhD Students presentations

• Dr Simone Lepage, University of Galway – The Kids Trial: Children shaping trials and the future
• Dr Ellen Murphy, University College Cork – Retention strategies for clinical trials: exploring the costs, planning, and communication processes
• Dylan Keegan, University College Dublin – Sustainability in clinical trials

14:10–14:40: Panel Discussion

14:40–15:00: Refreshment Break

Session 3: Operationalising International / Complex Design Trials (Chair: Prof. Ger Curley, Royal College of Surgeons Ireland)

15:00–15:15: Rethinking informed consent for an ICU Platform Trial: Lessons learned from a SWAT – Dr. Heather O’Grady, McMaster University

15:15–15:30: Patient and Public Involvement in Platform Trials – Dr. Leanne Hays, University College Dublin

15:30–15:45: Data coordination, funding, regulation in platform trials – Mr. Paul Mouncey, UK Intensive Care National Audit & Research Centre

15:45–16:00: Panel Discussion 

Session 4: Collaboration With Global Partners (Chair: Dr Darren Dahly, University College Cork)

16:00–16:15: Research Collaborations across Asia and Africa – Dr. Madiha Hashmi, ISARIC

16:15–16:30: Built from the South: Infrastructure, Funding and Collaboration in Brazilian Critical Care Research – Dr. Israel Maia, Federal University of Santa Catarina

16:30–16:45: Curiosity, Humility & Democracy – Experiences of International Collaboration in Clinical Trials – Dr. Timo Tolppa, University of British Columbia

16:45–17:00: Panel Discussion

Closing Remarks & Next Steps

17:00–17:15: Symposium close – Prof. Declan Devane, University of Galway

Click here to download schedule

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.

To register, CLICK HERE

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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Pilot and feasibility studies for phase III trials are primarily designed to provide feasibility evidence for large trials intended to generate evidence on effects of benefit and harm of a drug or intervention. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. This presentation will cover some key aspects of pilot studies for phase III trials including past practice history; the general reasons for conducting a pilot study; the relationships between pilot studies, and proof-of-concept studies; the challenges of and misconceptions about pilot studies; the criteria for evaluating the success of a pilot study;  frequently asked questions about pilot studies; some ethical aspects related to pilot studies; and ongoing efforts to improve current and future practice

Speaker:

Dr. Lehana Thabane is a Vice President of Research at St Joseph’s Healthcare—Hamilton and St Joseph’s Health System; Scientific Director of the Research Institute at St Joseph’s Healthcare; Distinguished Professor University in the Department of Health Research Methods, Evidence, and Impact at McMaster University. He is a Fellow of the World Academy of Science, the Royal Society of Canada, the African Academy of Sciences, the American Statistical Association, the Society for Clinical Trials, the Canadian Academy of Health Sciences, and Honorary Foreign Associate Member of the Academy of Science of South Africa. He is the Past President of the Society for Clinical Trials 2022-2023. He is the recipient of the 2022 of the Statistical Society of Canada Award for Impact of Applied and Collaborative Work. He was a recipient of an honorary degree from Stellenbosch University in South Africa in December 2023 for his contribution to clinical trial methodology.

Dr Thabane is the Emeritus Founding Editor-in-Chief of the journal Pilot and Feasibility Studies; and he is a member of the editorial board for many journals including Trials, and BMJ Open. He has co-authored over 1300 peer-reviewed manuscripts leading to significant contributions and transformation of science, healthcare, and delivery of care in many clinical areas. Having mentored over 200 graduate students and junior faculty, Dr Thabane has won several teaching and mentorship awards for his commitment to building capacity in health research and nurturing the next generation of researchers

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The COVID-19 pandemic has create many challenges for clinical trials. On the one hand running studies have been severely affected while on the other hand many challenges arose for trial looking at treatments for COVID. Platform trials have become a particularly popular solution to evaluate treatment for COVID. In this talk, Prof. Jaki will discuss his experiences with early COVID trials in China and how they influenced the design of the adaptive platform trial RECOVERY. He will also discuss some of the statistical aspect of its design and reflect on some of the open questions to make platform trials even more broadly applicable.

Speaker:

Prof. Thomas Jaki is the Professor of Computational Statistics at the University of Regensburg and MRC Professor of Statistics and Programme Leader in the Efficient Study Design theme at the MRC Biostatistics Unit. My work focuses on developing and evaluating novel statistical methods for clinical studies. These methods are adapted for specific applications to ensure they can be used in the pharmaceutical industry and also in public sector research institutions. My current research focuses on model-based dose-finding trials as well as Master protocols.

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The SPIRIT and CONSORT Statements are widely adopted reporting guidelines for reporting of trial protocols and results of randomised trials. This webinar will present the updated SPIRIT 2025 and CONSORT 2025 guidelines (published simultaneously in the BMJ, JAMA, Lancet, Nature Med and PLoS Med) which have been extensively revised to reflect recent methodological advancements and feedback from end users. The updated guidelines followed established methodology involving evidence-based recommendations and expert consensus. Updating the SPRIT and CONSORT checklists together also allowed alignment of the content, providing consistent guidance on reporting a trial through its life-cycle, from design to results.

This webinar will highlight a number of substantive changes to SPIRIT 2025 and CONSORT 2025, including the rationale for the addition of new items and revising the content of existing items. Both checklists have also been restructured, with a new section on Open Science, which includes items conceptually linked, such as trial registration, where the trial protocol and statistical analysis plan can be accessed, sharing of de-identified participant level data, funding and conflicts of interest. The wording between CONSORT and SPIRIT checklist items has also been revised to clarify and simplify items. Together, SPIRIT 2025 and CONSORT 2025 provide updated, harmonised guidance for reporting randomised trial protocols and results, respectively. Their adherence has potential to enhance the transparency of trial reporting for the benefit of authors, editors, and others.

Speaker:

Professor Sally Hopewell is Professor of Clinical Trials and Evidence Synthesis based at the Oxford Clinical Trials Research Unit and Centre for Statistics in Medicine, University of Oxford. She is involved in leading the design and delivery of clinical trials within the OCRTU portfolio. Her key areas of research expertise are in the design, conduct and transparent reporting of randomised trials and systematic reviews. Prof Hopewell has published (h-index 86) more than 300 studies in these areas, and has been instrumental in leading the development of key reporting guidelines including the CONSORT 2025 and SPIRIT 2025 Statements which were published simultaneously in the BMJ, JAMA, Lancet, Nature Med and PLoS Med. She is also chief investigator on NIHR funded trials of in the areas of paediatric and adult rehabilitation and musculoskeletal sciences and co-investigator on a number of other NIHR funded trials and evidence synthesis. She has a particular research interest in data sharing, development of core outcome sets, pilot and feasibility studies, paediatric trials and trials of complex interventions.