Upcoming Events

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Overview: It is imperative that trial teams plan, design, conduct and report trials that are inclusive of individuals for whom the findings are relevant. The aim of this Winter School is to build knowledge, awareness, and capacity to inform, support and evaluate equality, diversity, and inclusion in trials through high quality qualitative research. Structured around interactive workshops and knowledge exchange activities, the day will focus on qualitative research across the life cycle of trials, identifying and exploring key areas of inclusive trial methodology.

Dates: 19th October 2023

Location: CA005, Cairns Building, University of Galway

Places: 28

Cost: General €50, Student €30

Structure of Day:

Session 1

• Introduction to qualitative research
• Introduction to qualitative research in trial methodology
• Introduction to core concepts of EDI within the context of qualitative research in trial methodology
• Case studies aligning qualitative research to key areas of inclusive trial methodology across the life cycle of trials (planning, design, conduct and reporting)

 Session 2

Breakout discussions focusing on EDI within

• Qualitative evidence in core outcome set development
• Qualitative evidence synthesis contributing to inclusive trial methodology
• Study withing a trial (SWAT) – qualitative evidence informing inclusive trial methodology

Summary session

Knowledge exchange activity

• Establish the state of the science in relation to qualitative research for inclusive trials methodology
• Collectively identify future actions and next steps

Facilitators:

Dr Laura Jones, Associate Professor of Qualitative and Mixed Methods Applied Health Research, University of Birmingham

Dr Linda Biesty, Senior Lecturer in Midwifery, University of Galway

Dr Catherine Houghton, Associate Professor, School of Nursing and Midwifery, University of Galway & Co-Chair of QUESTS

Dr Andrew Hunter, Lecturer in Mental Health and Qualitative Research in Trials, University of Galway & Co-Chair of QUESTS

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

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Date: 20th October 2023

Location: Galway Bay Hotel

Cost: General – €100; Student – €50

A total of 4.5 CPD credits have been assigned to this event

Download the Schedule here 

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

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Dementia Trials Ireland are delighted to announce this half day webinar, coordinated by Dementia Trials Ireland, a HRB Clinical Trial Network, and in partnership with the HRB-TMRN, comprised of 4 sessions. This event may be of interest to early career researchers (clinical, academic), clinical investigators, research nurses or allied health professionals with an interest in dementia clinical trials.

Sessions 1-3 (delivered by clinical research and trial coordination experts) will introduce participants to the concepts and considerations central to effective development and delivery of dementia clinical trials in an Irish context to include:

• Legal / Ethical and site feasibility
• Contracts, budgets and regulatory/quality considerations
• Green light and subsequent trial coordination requirements
• Event reporting, data management and audits
• Trial close out

In Session 4, attendees will ‘Meet the Experts’ who will speak to their experience of the day-to-day realities of successfully conducting and delivering a dementia clinical trial in Ireland.

Session 4 Panel:

Dr Rónan O’Caoimh

DTI Steering Committee member

Consultant Geriatrician, Mercy University Hospital, Cork

Prof. Seán Kennelly

Co-Lead DTI

Consultant Physician in Stroke and Geriatric medicine, Tallaght University Hospital Dublin

Clinical Associate Professor of Medical Gerontology, Trinity College Dublin

Director of the Institute for Memory and Cognition

Director of Cognitive Clinical Trials Unit, Tallaght University Hospital

Prof. Brian Lawlor

DTI Steering Committee member

Professor of old age psychiatry, Trinity College Dublin

Site Director of GBHI at Trinity College Dublin

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This webinar will explore the adaptation and application of implementation science to the design, evaluation, and implementation of clinical trials. In brief, we will discuss the consideration of clinical trials as evidence-based practices with substantial benefits to individuals and society, but suffering from poor implementation. We will consider the adaptation of implementation science frameworks to identify barriers and facilitators to trial conduct, including enrollment, the use of implementation outcomes in the clinical trials context, the targeting of tailored interventions to improve trial conduct, and early experiences in the pragmatic application of these frameworks and conceptual models.

Dr. Kristian Stensland is an Assistant Professor of Urology at the University of Michigan. His research interests are primarily in improving the conduct, efficiency, and equity of clinical trials through informatics, infrastructure, and implementation science. His clinical work as a urologic surgeon focuses on care for people with urologic cancers. Kristian completed a fellowship in urology oncology and health services research at the University of Michigan in 2023 after finishing his urologic surgical residency at Lahey Clinic in Boston, Massachusetts.  He completed a Master of Public Health at the Harvard TH Chan School of Public Health, and a Master of Science in Health Infrastructures and Learning Systems focused on implementation science at the University of Michigan. His work has been funded by the US National Institutes of Health. Aside from his research and clinical interests, Kristian is a proud dad, an avid runner, and enthusiastic (American) football fan.

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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.

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Clinical trials aim to draw conclusions about the effects of treatments, but different trials can address quite different questions. For example, does the treatment work when it is received as prescribed?, or does the treatment work even if not all treatment is received? Since different questions can lead to different conclusions on treatment benefit, it is important to have a clear understanding of precisely what treatment effect a trial aims to investigate – this is what we call the ‘estimand’. Using estimands helps to ensure trials are designed and analysed to answer the questions of interest to different stakeholders, including patients and public partners. Public partners are patients or members of the public who are part of the research team. In this webinar we explore public partner’s perspectives on the importance of discussing estimands when designing a trial and present a co-developed practical tool that helps explain what an estimand is and what impact it may have in trial results.

Suzie Cro is a Senior Lecturer in medical statistics and clinical trials, head of statistics and trial methodology at Imperial Clinical Trials Unit (ICTU), Imperial College London. She has over 13 years’ experience in the design and analysis of clinical trials and other interventional studies across clinical areas including ophthalmology, dermatology, musculoskeletal and opiate addiction. She holds a personal NIHR advanced research fellowship to translate the ICH-E9R1 addendum on estimands into best statistical practice and to develop accessible statistical methods to estimate treatment estimands in randomized controlled trials where clinical outcomes have been affected by intercurrent events. Her other statistical research interests include handling missing data and transparency in the statistical analysis of clinical trials. She obtained her PhD in medical statistical from the London School of Hygiene and Tropical Medicine.

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Co-hosted with the UCL Institute of Clinical Trials and Methodology and the Irish Critical Care Clinical Trials Network

Independent Data Monitoring Committees play a critical role for any clinical trial. They are usually the only body that sees accumulating, comparative data from the trial. There have been few opportunities for people, particularly clinicians, to gain experience or much hands-on knowledge before being asked to attend as a meeting. This course fills that gap and will answer the question: ‘What do people who serve on them, report to them or receive reports from them need to know?”

Running virtually, it will be a mix of 3 sessions comprised of discussion, exercises and Q&A, together with pre-recorded lectures to watch between sessions. There is an optional 4th session on the 20th March that will run for one hour for any delegates who wish to discuss remaining questions that have arisen in the time following the workshop.

Places on this course are being prioritised for those in academic / clinical settings who will need to join an IDMC as part of their trial governance commitments. To apply for a place on this course, please fill out this application form

Dates: 19th, 20th & 21st February 2024

Location: Online

Places: 30 (exclusive to residents on the island of Ireland)

Time: 10am – 1pm

Cost: Academic / Clinical – €250; Private Sector – €500

Schedule: TBC

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