Upcoming Events

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TMRP Methodology webinar – hosted by Elizabeth Allen, Kerry Hood, Amy Russell, Victoria Shepherd, Tanya Symons, Tsaone Tamuhla and Julia Wade on behalf of the Global Health Network

Adequate and ethical informed consent for trials and other types of clinical research remains problematic. How to offer enough information without overwhelming, provide options for potential re-use of retained data and samples, and handle particularly complex trial designs or where consent-based challenges contribute to the exclusion of certain populations? The Global Health and Trial Conduct Working Groups will co-host a webinar showcasing perspectives on these issues from the UK, South Africa and Australia, which may also foster future innovation and collaboration.

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Dates: 30th & 31st March 2023

Location: Durkin Theatre, Trinity Translational Medicine Institute, St James’s Hospital, Dublin 8

Level: Beginners

Places: 150

Cost: General €150, Student €75

CPD Points: 10.0 credits have been awarded to this event – Day 1: 5.0 CPD credits; Day 2: 5.0 CPD credits

Time, Speakers & Schedule:

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

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This course aims to provide an introduction to the challenges of recruiting patients to randomised controlled trials (RCTs) and strategies that could be employed to address these. Particular emphasis will be placed on how to introduce and explain RCTs to potential participants to optimise informed consent and reduce missed opportunities for recruitment. Examples will be drawn primarily from trials set in secondary care hospital settings that span a range of medical specialities.

Date: 19th April 2023

Location: Online

Pre-requisites: It would be advantageous if course attendees have some knowledge and understanding of randomised controlled trials (RCTs). The course does not go into detail about the design/conduct of RCTs, and therefore individuals unfamiliar with this study design may consider first attending the Designing and Conducting Pragmatic Randomised Controlled Trials short course. Experience of having worked on an RCT would be particularly beneficial, although not essential.

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This course aims to illustrate how qualitative research can be used to optimise the design and conduct of randomised trials, particularly pragmatic trials of complex interventions.

Date: 21st April 2023

Location: Online

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Informed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of populations and settings. These include people with communication or other disabilities, people whose capacity to consent fluctuates, adults who lack capacity to consent, and adults and children in emergency and urgent care settings. These challenges, and the subsequent complexity of conducting trials where alternative consent pathways are required, contribute to these populations being underserved in research. A UK-wide collaboration, a sub-group of the MRC-NIHR TMRP Trial Conduct Working Group, has been formed to collectively address these challenges. Members are drawn from disciplines including bioethics, qualitative research, trials methodology, healthcare professions, and social sciences. In this webinar, members of the collaboration will outline the methodological and ethical challenges issues arising in populations where consent is complex, summarise research that aims to address these challenges, and identify targets for future research.

The speakers are all from a sub-group of the MRC-NIHR TMRP Trial Conduct Working Group. The sub-group looks at complex & alternative consent pathways.

Dr Amy M. Russell is a Senior Research Fellow at the University of Leeds. Her research focuses on addressing health inequalities in research design and governance, and clinical practice for “under-served” populations. She coordinated the largest UK feasibility RCT with people with a learning disability and diabetes. Her current research, funded by Wellcome and NIHR and collaborating with the HRA and MRC-NIHR Trial Research Methodology Partnership, aims to improve inclusion in applied health research for under-served populations with a particular focus on people with a learning disability. She works closely the WHO Disability Team, collaborating on the Global Report on Health Equity for People with a Disability 2022 and is the PI on an AHRC interdisciplinary Network to explore the role of arts and humanities methods to improve sexual and reproductive health care for women with disabilities

Dr Victoria Shepherd is a Senior Research Fellow in the Centre for Trials Research at Cardiff University where she leads a research programme exploring the ethical and methodological challenges around trials involving adults with impaired capacity to consent. Her work has included the development of a novel decision support intervention for families acting as research proxies, and a core outcome set for the evaluation of interventions to enhance proxy consent decisions about research. Her current project (CONSULT) includes a qualitative study exploring the barriers and facilitators to conducting trials involving adults who lack capacity and a SWAT to evaluate the decision support intervention in a range of trials and settings. She also co-leads the development of the ‘NIHR INCLUDE Impaired Capacity to Consent Framework’, which aims to support researchers to consider the ethical, legal, and methodological issues surrounding trials involving adults with impaired capacity, and to design trials that are more inclusive of these populations

Dr Kerry Woolfall is a Reader in Health Research Methodology at University of Liverpool where she leads the Patient Centred Trials research group. She is methodologist with a mixed methods social science background. Her programme of work explores patient, family and clinician perspectives to inform the design and conduct of health research. With expertise on consent in emergency and critical care trials her work has included the creation of CONNECT and Perspectives study guidance, which helps to ensure recruitment and consent in time critical research is ethically appropriate and in line with the priorities of critically ill patients and their families. Her current work includes eight NIHR funded feasibility or studies within trials (SWATS) exploring aspects of clinical trials methodology, such as approaches to consent, recruitment, trial acceptability and trial design. This research spans neonatal, paediatric and adult populations in challenging research settings, including intensive care, obstetrics and emergency departments.

Dr Mark Jayes is Research Fellow in Communication Disability at Manchester Metropolitan University. His applied research explores how people with communication disabilities access information, how they participate in everyday decision-making, and how they can be involved and participate meaningfully in research. Mark has investigated policy-practice gaps in the implementation of mental capacity legislation within care and research processes for this underserved population, the social justice implications of these, and potential ways to address observed inequities. He is passionate about translating his research into high quality outputs that have real world impact. These outputs include book chapters in clinical textbooks and actionable tools to enable care practitioners and researchers to improve their practice, for example the Consent Support Tool and the Mental Capacity Assessment Support Toolkit (MCAST). Mark is also a qualified speech and language therapist with extensive clinical experience of working with adults with communication and swallowing disabilities in NHS settings.

Dr Julia Wade is a qualitative methodologist and Senior Lecturer in Qualitative Health Science applied to Randomised Controlled Trials. She is a member of the QuinteT team of researchers, which pioneers qualitative approaches to optimise recruitment and informed consent to randomised controlled trials (RCTs) at the University of Bristol. Current research interests include optimising recruiter communication and patient understanding for informed consent during trial recruitment; optimising screening and consent processes for groups that are traditionally underserved in trials and other research; and the communication of trial findings to patients, clinicians and policy makers

Dr Anna Volkmer is an NIHR funded Senior Research Fellow in Language and Cognition at University College London. She is particularly interested in dementia, and her research focuses on developing speech and language interventions for people with language led dementias and their families. Anna is also employed as a senior speech and language therapist at the National Hospital for Neurology and Neurosurgery, working with people with dementia. Decision-making and mental capacity is particularly relevant to this client group and Anna has been involved in developing policy, at a national level, and increasing awareness around the needs of people with communication difficulties. Anna has also edited two books including ‘Dealing with Capacity and Other Legal Issues with Adults with Acquired Neurological Conditions: A Resource for SLTs’ (J&R Press), and written several chapters, on this subject and is developing a programme of research exploring communication support needs in relation to decision-making and mental capacity.

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Date: 5th May 2023

Location: J. E. Cairnes Building, University of Galway

Places: 30

Time: 09:00 – 16:30

Cost: General – €100; Student – €50

Background:

Health economic evaluation methods are employed to provide evidence on the cost effectiveness of health technologies and health and social care interventions. This evidence forms part of the multidisciplinary health technology assessment (HTA) process in Ireland and internationally, which is central to informing resource allocation decision-making by policy makers and practitioners within and across health systems. To this end, there exists a need to educate relevant stakeholders on the conduct of health economic evaluation.

Aim:

This workshop aims to firstly, provide an introduction to the methods of health economic evaluation, and secondly, to provide guidance on the conduct of health economic evaluation alongside randomised controlled trials.

Objectives:

The objective of this workshop is to equip participants with the knowledge and tools to conduct a health economic evaluation alongside a randomised controlled trial

Learning outcomes:

In this course participants will be enabled to:

• Understand the principles and steps of the methods of health economic evaluation
• Understand the principles and steps in conducting a health economic evaluation alongside a randomised controlled trial

Topics to consider:

• Overview of Health Economic Evaluation Methods
• Costs for Health Economic Evaluation
• Health Outcomes for Health Economic Evaluation
• Statistical Analysis for Health Economic Evaluation
• Decision Analytic Modelling for Health Economic Evaluation
• Health Economic Evaluation Analysis Plans (HEAP)
• Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022) Statement: Reporting Guidance for Health Economic Evaluations
• Studies Within A Trial (SWATs) & Health Economic Evaluation
• Patient and Public Involvement (PPI) & Health Economic Evaluation
• Core Outcomes Sets & Health Economic Evaluation

Teaching strategies:

The workshop will consist of a mixture of presentations and participant feedback sessions.

Facilitator:

Professor Paddy Gillespie, Director of Health Economics & Policy Analysis Centre (HEPAC) University of Galway

Schedule:

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

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Decentralised clinical trials, which use technological and organisational methods to move clinical trial activities closer to their participants’ homes, have been suggested as a solution to recruitment, retention, and overall trial efficiency challenges. The Innovative Medicines Initiative-funded Trials@Home project is a public-private consortium aiming to promote good practice and adoption of decentralised clinical trial methods in Europe. As part of this project, researchers at the University of Dundee, Scotland, have identified and reviewed completed and in-progress clinical trials that have used decentralised methods to produce initial guidance on decentralised trial conduct. Additionally, interviews with staff, patient representatives, and other stakeholders involved in decentralised clinical trial case studies have supported qualitative research to produce actionable learning from their experiences. This webinar will give an overview of the Trials@Home project and present the systematic review and case study findings.

Dr Amy Rogers is a Clinical Lecturer with MEMO Research at the University of Dundee. Having previously worked as General Practitioner, Amy now researches pragmatic clinical trial methods, focusing on the implementation of decentralised and healthcare-embedded clinical trials. Recent projects have included the ALL-HEART, TIME, and EVIDENCE trials. She is also particularly interested in the role of public engagement and involvement in clinical trials.

Co-hosted with the MRC-NIHR Trials Methodology Research Partnership

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Date: 15th May 2023

Location: Online

Places: 60

Time: 10:00 – 16:00

Cost: General – €125; Student – €75

Schedule:

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

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Date: 21st – 24th May 2023

Location: Baltimore Marriott Waterfront, Baltimore,  Maryland, USA

Annual Meeting Theme: “Championing High-quality Evidence to Optimize Human Health”

The Annual Meeting of the Society for Clinical Trials is a multidisciplinary program with broad participation. The meeting brings together the clinical trials community from academia, the pharmaceutical and device industries, government agencies, medical groups and centers and clinical research entities.

Highlights include:

• Plenary sessions, topical sessions and contributed presentations on many clinical trial related topics.
• In-conference educational workshops, offering guidance on both classical and topical issues in clinical trials
• Annual Thomas C. Chalmers Student Scholarship and Sylvan Green Award competitions
• Discussion of timely issues and research experiences among colleagues in the field of clinical trials
• Presentation of the 2022 David Sackett Trial of the Year Award
• Presentation of the SCT Class of 2023 Fellows

The program is being developed by the SCT Program, Education, and Student Scholarship Committees, and promises to make the best of this unique opportunity for global collaboration.

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.

Date: 5th – 9th June 2023

Location: Online

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This talk investigates the statistical design features of a breast cancer risk reduction Bayesian adaptive trial. Most adaptive designs have interim analyses that allow for early stopping, typically utilizing only the primary endpoint. A drawback to this approach is that the study may not have enough data for adequate comparisons of a single, key secondary endpoint. In this talk, we investigate a trial design that stops early only if a criterion is met for primary and secondary endpoints. The approach focuses the final analysis on the primary endpoint but ensures adequate data for the secondary analysis. We present operating characteristics including power, trial duration, and type I error rate, and discuss the value and risks of modeling Bayesian adaptive designs with primary and secondary endpoints, comparing against alternative designs. Our approach balances trial speed and the need for information on the single, key secondary endpoint.

Prof. Byron Gajewski’s statistical methodological research interests center around Bayesian data analysis and its application to cancer prevention, emergency medicine, neurology, nursing, health professions, and other related fields. He is co-director of the Biostatistics & Informatics Shared Resource at the University of Kansas Cancer Center. He is an active faculty member in the Biostatistics Ph.D. program teaching and mentoring.

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Randomisation – the method by which participants are randomly allocated to treatment groups – is a fundamental feature of clinical trials. It allows valid estimation of standard errors, is vital to conceal allocations, and eliminates important sources of bias. There exist many different randomisation methods and each method may perform differently depending on the design of the trial. There is a lack of consensus on which methods are most appropriate in different situations. We conducted a review of papers published in five journals in 2019 to assess which randomisation methods are most commonly being used, as well as identifying which aspects of study design, if any, are associated with the choice of randomisation method. Randomisation methodology use was also compared with a similar review conducted in 2014. This webinar will summarise the methodology and findings of this review and discuss some of the next steps for this research.

Cydney Bruce is a Medical Statistician alongside being a part-time PhD student at the Nottingham Clinical Trials Unit, as part of the Trials Methodology Research Partnership’s cohort of PhD students. She has a BSc in Mathematics from Keele University and an MSc in Medical Statistics from the University of Leicester. Cydney’s main interest is in clinical trials methodology, and her PhD is focused on randomisation methodology, with the overarching aim of developing guidance for randomisation method selection in a clinical trial setting.

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Date: 20th October 2023

Location: Galway Bay Hotel

Cost: General – €100; Student – €50

Schedule TBC

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