Upcoming Events

Background & aim:

Independent data monitoring committees (IDMCs) are an important part of many clinical trials. This online series aims to give insight into how IDMCs work, who should sit on them, how to present to them and the decisions they make. We welcome those involved in any part of the IDMC process including clinicians, statisticians and trial coordinators/managers. The series will be led by Sharon Love and Elizabeth George who have extensive experience setting up, reporting to and sitting on multiple IDMCs.

Objectives:

Session 1 – Setting up an IDMC

Date & time: 10:00 – 12:00, 14th October 2026

Learn how to assess when independent oversight adds value to data monitoring committees and when this type of committee is needed along with understanding what independence means, and how to find the right IDMC members balancing clinical expertise, statistical insight and regulatory expectations.

Session 2 – The IDMC Meeting

Date & time: 10:00 – 12:00, 18th November 2026

Understand what key requirements are needed for a IDMC charter, as well as what should be included in IDMC reports to support robust and transparent discussions during the closed sessions. In addition learn when and how stopping guidelines are applied.

Session 3 – IDMC Decision making

Date & time: 10:00 – 12:00, 16th December 2026

Understand who is responsible for key decisions in a trial and how they interact with the IDMC, what would constitute a quorate meeting and how the IDMC’s recommendations influence the running of the trial. Examine real-world case studies to see how IDMC decisions reflect ethical considerations and shape trial impact.

Workshop 1 ONLY fee: General €40

Overall fee for 3 workshops: General €100

TO REGISTER, CLICK HERE

Facilitators:

Associate Professor Sharon Love, Innovative Clinical Trials Unit, University College London

Dr Elizabeth George, Innovate Clinical Trials Unit, University College London

Click here to register

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

Background & aim:

Trial Steering Committees (TSCs) provide the independent oversight at the heart of well-run clinical trials, yet practice varies and the role is often poorly understood. This online series offers a structured introduction to TSCs – their role, remit and responsibilities – and builds confidence to serve as a TSC member or chair. Through short expert talks and facilitated discussion of real-world scenarios, it clarifies how TSCs work alongside sponsors, funders, investigators, Clinical Trials Units/Clinical Research Facilities, Patient and Public Involvement (PPI) contributors and Data Monitoring Committees. It is aimed at anyone involved in trial oversight – including researchers, clinicians, statisticians and trial coordinators/managers – and supports capacity and networking across Ireland and the UK.

Objectives:

Workshop 1 – TSC roles, remit and responsibilities

Date & time: 10:00 – 12:00, 10th November 2026

Understand the core oversight role of the TSC and how it differs from those of the sponsor, funder, Principal Investigator, CTU/CRF and Data Monitoring Committee; the specific responsibilities of TSC members and the Chair; how funders (HRB, NIHR) and sponsors define a “successful TSC”; and the essential contribution of PPI to TSC deliberations.

Workshop 2 – TSCs in practice: real-world scenarios

Date & time: 10:00 – 12:00, 1st December 2026

Apply TSC guidance to challenging real-world situations through facilitated groupwork – for example, when the trial team proposes major sample size changes due to poor recruitment, and when the Data Monitoring Committee recommends early reporting of unblinded data for efficacy or safety – and reflect on your own readiness to serve as a TSC member or chair.

Fee for one workshop: General €40

Fee for both workshops: General €70

TO REGISTER, CLICK HERE

Facilitators:

Professor Athene Lane, Bristol Medical School, University of Bristol

Professor Carrol Gamble, Liverpool Clinical Trials Centre, University of Liverpool

Professor Gian Luca Di Tanna, University of Applied Sciences and Arts of Southern Switzerland (SUPSI)

Click here to register

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.

Background & aim:

Independent data monitoring committees (IDMCs) are an important part of many clinical trials. This online series aims to give insight into how IDMCs work, who should sit on them, how to present to them and the decisions they make. We welcome those involved in any part of the IDMC process including clinicians, statisticians and trial coordinators/managers. The series will be led by Sharon Love and Elizabeth George who have extensive experience setting up, reporting to and sitting on multiple IDMCs.

Objectives:

Session 1 – Setting up an IDMC

Date & time: 10:00 – 12:00, 14th October 2026

Learn how to assess when independent oversight adds value to data monitoring committees and when this type of committee is needed along with understanding what independence means, and how to find the right IDMC members balancing clinical expertise, statistical insight and regulatory expectations.

Session 2 – The IDMC Meeting

Date & time: 10:00 – 12:00, 18th November 2026

Understand what key requirements are needed for a IDMC charter, as well as what should be included in IDMC reports to support robust and transparent discussions during the closed sessions. In addition learn when and how stopping guidelines are applied.

Session 3 – IDMC Decision making

Date & time: 10:00 – 12:00, 16th December 2026

Understand who is responsible for key decisions in a trial and how they interact with the IDMC, what would constitute a quorate meeting and how the IDMC’s recommendations influence the running of the trial. Examine real-world case studies to see how IDMC decisions reflect ethical considerations and shape trial impact.

Workshop 2 ONLY fee: General €40

Overall fee for 3 workshops: General €100

TO REGISTER, CLICK HERE

Facilitators:

Associate Professor Sharon Love, Innovative Clinical Trials Unit, University College London

Dr Elizabeth George, Innovate Clinical Trials Unit, University College London

The National Institute for Health and Social Care Research (NIHR), as well as other funders, are increasingly requiring Knowledge Mobilisation approaches to be incorporated into research grant applications to strengthen pathways to impact. Knowledge mobilisation is used to share knowledge between different communities, to create new knowledge and catalyse change.

Academics at the Applied Research Collaboration South West have been exploring and developing these approaches for the past decade and have worked with colleagues at the NIHR. This course will introduce the key concepts and definitions in the field and the latest developments. It will also take attendees through the process of designing a Knowledge Mobilisation plan for a research project.

Date: 30th November 2026

Fee: £250

Location: Online

For more information and to register, click here

Please contact short-course@bristol.ac.uk with any questions.

Background & aim:

Trial Steering Committees (TSCs) provide the independent oversight at the heart of well-run clinical trials, yet practice varies and the role is often poorly understood. This online series offers a structured introduction to TSCs – their role, remit and responsibilities – and builds confidence to serve as a TSC member or chair. Through short expert talks and facilitated discussion of real-world scenarios, it clarifies how TSCs work alongside sponsors, funders, investigators, Clinical Trials Units/Clinical Research Facilities, Patient and Public Involvement (PPI) contributors and Data Monitoring Committees. It is aimed at anyone involved in trial oversight – including researchers, clinicians, statisticians and trial coordinators/managers – and supports capacity and networking across Ireland and the UK.

Objectives:

Workshop 1 – TSC roles, remit and responsibilities

Date & time: 10:00 – 12:00, 10th November 2026

Understand the core oversight role of the TSC and how it differs from those of the sponsor, funder, Principal Investigator, CTU/CRF and Data Monitoring Committee; the specific responsibilities of TSC members and the Chair; how funders (HRB, NIHR) and sponsors define a “successful TSC”; and the essential contribution of PPI to TSC deliberations.

Workshop 2 – TSCs in practice: real-world scenarios

Date & time: 10:00 – 12:00, 1st December 2026

Apply TSC guidance to challenging real-world situations through facilitated groupwork – for example, when the trial team proposes major sample size changes due to poor recruitment, and when the Data Monitoring Committee recommends early reporting of unblinded data for efficacy or safety – and reflect on your own readiness to serve as a TSC member or chair.

Fee for one workshop: General €40

Fee for both workshops: General €70

TO REGISTER, CLICK HERE

Facilitators:

Professor Athene Lane, Bristol Medical School, University of Bristol

Professor Carrol Gamble, Liverpool Clinical Trials Centre, University of Liverpool

Professor Gian Luca Di Tanna, University of Applied Sciences and Arts of Southern Switzerland (SUPSI)

Click here to register

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.

This course aims to provide an introduction to the importance of inclusivity in health research, key issues to consider while designing your study and tools to optimise inclusivity. We will draw from work led by academics at the University of Bristol and other institutions, the literature on developing inclusive methodology and strategies used to reduce inequities in health research. Course content will provide an overview covering multiple under-served groups (e.g., people with autism, those experiencing socio-economic disadvantage), with a focus on strategies that enable inclusivity of ethnic minority groups.

This course aims to provide a broad understanding of the why and how of considering inclusivity throughout the life cycle of a research project, with an added emphasis on ethnic minority group inclusion.

Date: 10th December 2026

Fee: £250

Location: Online

For more information and to register, click here

Please contact short-course@bristol.ac.uk with any questions.

Background & aim:

Independent data monitoring committees (IDMCs) are an important part of many clinical trials. This online series aims to give insight into how IDMCs work, who should sit on them, how to present to them and the decisions they make. We welcome those involved in any part of the IDMC process including clinicians, statisticians and trial coordinators/managers. The series will be led by Sharon Love and Elizabeth George who have extensive experience setting up, reporting to and sitting on multiple IDMCs.

Objectives:

Session 1 – Setting up an IDMC

Date & time: 10:00 – 12:00, 14th October 2026

Learn how to assess when independent oversight adds value to data monitoring committees and when this type of committee is needed along with understanding what independence means, and how to find the right IDMC members balancing clinical expertise, statistical insight and regulatory expectations.

Session 2 – The IDMC Meeting

Date & time: 10:00 – 12:00, 18th November 2026

Understand what key requirements are needed for a IDMC charter, as well as what should be included in IDMC reports to support robust and transparent discussions during the closed sessions. In addition learn when and how stopping guidelines are applied.

Session 3 – IDMC Decision making

Date & time: 10:00 – 12:00, 16th December 2026

Understand who is responsible for key decisions in a trial and how they interact with the IDMC, what would constitute a quorate meeting and how the IDMC’s recommendations influence the running of the trial. Examine real-world case studies to see how IDMC decisions reflect ethical considerations and shape trial impact.

Workshop 3 ONLY fee: General €40

Overall fee for 3 workshops: General €100

TO REGISTER, CLICK HERE

Facilitators:

Associate Professor Sharon Love, Innovative Clinical Trials Unit, University College London

Dr Elizabeth George, Innovate Clinical Trials Unit, University College London

Co-producing a research project is an approach in which researchers, practitioners and the public work together, sharing power and responsibility from the start to the end of the project (NIHR, 2021). This course focuses on involving members of the public, to ensure more democratic, relevant research/ services that make a difference in practice. This course will be particularly useful for researchers considering using co-production, co-design or participatory action research, people co-designing services/ interventions or anyone wanting to find out more.

This course will provide an introductory overview of approaches where researchers and practitioners work in partnership with members of the public to co-produce/ co-design research, services or interventions. Participants will learn about the theory of these approaches and apply principles into action through case studies and their own/ others work. We draw on the expertise within the University of Bristol and beyond, with course tutors who are researchers, public involvement specialists and community members, who all have extensive experience in this field.

Date: 11th January 2027

Fee: £250

Location: Online

For more information and to register, click here

Please contact short-course@bristol.ac.uk with any questions.

Health research, whether population based, epidemiological or randomised controlled trials, must comply with a host of standards and legislation. The course is led by staff who have many years’ experience in health research and have been involved in a wide range of high impact health research projects. Invited tutors provide specialist expertise for complex areas such as Data Protection.

This course is designed for researchers who are new to health research, providing an overview of all you need to consider, and signposting further information and support. You will leave the course knowing which standards and legislation apply to your work, where to go for further support and armed with practical tips on how to fulfil your obligations as a health researcher. Please note that this is an introductory course and not designed for those already experienced in this field who may have specific, complex queries.

Date: 12th – 13th January 2027

Fee: £500

Location: Online

For more information and to register, click here

Please contact short-course@bristol.ac.uk with any questions.

Click here to register

The ICH E9(R1) addendum on estimands is becoming more commonly used in randomised trials. However, there is still limited guidance on which estimands should be used, or how they should be estimated. In this talk I will provide an overview of current proposals for choosing estimands, discuss the trade-offs between clinical relevance and statistical reliability, and discuss ongoing work to help investigators choose between different methods. I will then discuss the implications this has for which estimands and statistical analysis methods should be used in randomised trials.

Speaker:

Dr Brennan Kahan is Principal Research Fellow at the UCL Innovative Clinical Trials Unit. His research program is focussed on developing methods to improve the design, analysis, and reporting of randomised trials. His major research interests include the use of estimands in randomised trials, estimation methods for different intercurrent event strategies, and methods for complex trial designs such as cluster, non-inferiority, and factorial. He has co-authored over 130 publications, including the CONSORT 2025 and SPIRIT 2025 statements, led the CONSORT extension for factorial trials, and is currently updating the CONSORT extension for non-inferiority trials.

Click here to register

The learning objectives of this webinar are:

• Recognize what cluster randomized and stepped wedge trials are
• Understand the concept of intracluster correlation and its implications for trial design and analysis
• Describe potential risks of bias and strategies for reducing these risks in cluster randomized and stepped wedge trials
• Identify key advantages and disadvantages of stepped wedge cluster randomized designs
• Know where to find additional tools and resources for designing cluster randomized and stepped wedge trials

Speaker:

Prof. Monica Taljaard is a Senior Scientist in the Clinical Epidemiology Program at the Ottawa Hospital Research Institute (OHRI) and Full Professor in the School of Epidemiology and Public Health at the University of Ottawa. Her main research interests are in the design, analysis and ethics of pragmatic and cluster randomized trials. As a methodologist with the Ottawa Methods Centre, she works with clinicians and researchers from a variety of backgrounds in the design and analysis of their studies including clinical trials and observational studies. She is Deputy Editor of Clinical Trials: Journal of the Society for Clinical Trials.

Questionnaires are widely used for data collection in health research and evaluation. Their design, use and analysis are key to accurate, comprehensive and complete data. This course is an introduction to questionnaire design, application and data interpretation delivered by researchers and healthcare professionals experienced in developing, conducting and analysing questionnaire-based research for use in health services research and healthcare.

This course provides an introduction to the theoretical and practical approaches to questionnaire design, application and data interpretation. It covers an overview of processes involved in questionnaire development, testing, administration and data management to provide a basic understanding of the key concepts and approaches when using questionnaires to collect healthcare data and measure outcomes.

Date: 13th – 15th April 2027

Fee: £750

Location: Online

For more information and to register, click here

Please contact short-course@bristol.ac.uk with any questions.

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.

Date: 10th May 2027

Fee: £250

Location: Online

For more information and to register, click here

Please contact short-course@bristol.ac.uk with any questions.

Pragmatic Randomised Controlled Trial (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. Please note this course does not go into lots of detail about regulatory approvals and research governance.

Date: 17th – 21st May 2027

Fee: £1,250

Location: Online

For more information and to register, click here

Please contact short-course@bristol.ac.uk with any questions.

Protocols are essential for many areas of health research and a quality protocol is key to the successful delivery of a study. Academics working in the Bristol Trials Centre (BTC) and the University of Bristol (including those who are tutors on this course) have many years of experience in writing and delivering a wide range of protocols for high impact health research projects.

This course is aimed at health researchers new to writing protocols, and will cover the essentials of writing a good quality protocol for a range of health research projects. Core knowledge will be supplemented by practical tips and illustrated by real life examples, with signposting of relevant guidance and support.

Date: 21st June 2027

Fee: £250

Location: Online

For more information and to register, click here

Please contact short-course@bristol.ac.uk with any questions.

This course will demonstrate how qualitative research can be used to address particular trial design and conduct issues, enhance understanding of how qualitative methods can be integrated at various stages of a trial, show how a range of qualitative methods can be used within trials, and facilitate greater confidence in including qualitative research in grant applications for randomised trials. It is not a course on how to do qualitative research but rather a course on how to appreciate its value within trials.

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: 5th July 2027

Fee: £250

Location: Online

For more information and to register, click here

Please contact short-course@bristol.ac.uk with any questions.