Events across the Network

Learning and Development Opportunities for Researchers and Trialists

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July 2024

Title: PIS Workshop – how to design clear and accessible Patient Information Sheets
Date: 1 July 2024
Timings: 10:00 – 12:30
Location: Online via Zoom
Course tutors: Linda Von Neree, Patient and Public Involvement and Engagement (PPIE) Lead, BRTU PPI Lead and Giulia Pellizzari, PhD, Lecturer/Education Lead, Cancer Research UK & UCL Cancer Trials Centre.

Patient Information Sheets (PIS) are a key document for potential participants to make an informed decision about whether to take part in a clinical study. While there is clear guidance from the Health Research Authority (HRA) on content and regulatory requirements, PIS are customised for each clinical trial and the specific patient population. Choosing the right language and format for patient facing materials for research studies and clinical trials still greatly varies and depends on the skills and experience of the team putting them together.

In this workshop, attendees will gain useful insights on how to work on the format, language and delivery of the PIS thanks to the participation of patient representatives with experience in clinical trials of different phases and with different clinical interventions. The session includes an initial overview of the HRA guidance on the PIS design, an introduction to writing in plain English and a patient’s perspective in providing consent to a clinical study, followed by group work where research staff will go into virtual breakout rooms with Patient and Public representatives to review together a PIS that will be provided to the attendees a week prior to the course. Most importantly, at the end of the course, participants will be provided with a “PIS Checklist”: a memorandum of the considerations to take into account when designing (or reviewing) a Patient Information Sheet.

For more information, and to register, click here.

The Medical Statistics Department (MSD) at the London School of Hygiene and Tropical Medicine (LSHTM) will be running a short course on the essentials of clinical trials. This popular course has been running since 1999, each year receiving very positive feedback from those attending. The course is taught by staff at LSHTM who have extensive experience in the design, conduct and analysis of clinical trials. The teaching consists of a blend of theory and application through a combination of lectures and practicals. The course will be delivered using a hybrid format with students able to attend either in person at LSHTM or online.

This course provides attendees with a clear understanding of the fundamental principles of Randomised Clinical Trials (RCTs). Lectures and practical sessions cover the key issues to be considered in design, conduct, analysis and reporting, with a focus on major clinical trials which directly influence clinical practice. Topics are addressed with perspectives from both public sector research and the pharmaceutical industry. The course is relevant to those who are keen to gain an understanding of the rigorous evaluation of interventions in health care, including clinical research professionals, research managers, and other scientists with an interest in clinical trials.

Please note that places on the course are limited and applying early is advised.

The course runs for 5 days from the 1^st  to 5^th  July 2024.

**The course is awaiting approval by the UK Royal College of Physicians for Continuing Professional Development (CPD) credits. Historically it has carried 30 credits**

For further information and an application form please visit: https://www.lshtm.ac.uk/study/courses/short-courses/clinical-trials

Title: GMP for IMP
Date: 3 July 2024
Timings: 10:00 – 15:00
Location: Online via Zoom
Course Facilitators: Jo Burmester

This training will provide participants with an understanding of the legislation and guidance covering manufacture and handling of investigational medicinal products in the EU. The main document we focus on is Annexe 13 of Eudralex Volume 4 which covers requirements for manufacture of medicinal products specifically for use in a clinical trial setting. We also consider key GMP changes coming with the new EU Clinical Trials Regulation and associated guidelines. We also cover the EU Guideline on IMPs and Non-IMPs – soon to be updated to Auxiliary Medicinal Products. We also include an interactive workshop session looking at Site Management of IMP: Personnel, Premises and Processes.

Intended audience
This course is suitable for anyone involved in manufacture and/or management of Investigational Medicinal Products in clinical trials, for example: Clinical Project Managers, CRAs, CTAs, Clinical Trial Pharmacists, Contract Manufacturers.

Objectives
To provide delegates with an understanding of:
– Legislation and guidance covering manufacture and handling of investigational medicinal products in the EU/UK
– Recent and forthcoming changes in regulatory requirements
– Practical implications for clinical trials

For further information, and to register, please visit www.ucl.ac.uk/clinical-trials-and-methodology/study/short-courses/gmp-imp.

Title: Trial outcomes: what are we trying to measure?
Date: 4 July 2024
Time: 10:00-13:00
Venue: 90 Tottenham Court Road, W1T 4TJ
Course lead: Will Wilson, Statistician, CR UK & UCL CTC

This session, aimed at non-statisticians, will cover the most common primary outcomes measures used in early and late phase cancer trials.

Participants will learn what makes a good outcome measure, how outcomes measures are defined and what data need to be collected to assess the outcome, especially for tumour response assessment and time to event measures such as survival and disease (or progression) free survival.

Register here.

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September 2024

Title: Contemporary Clinical Trials ONLINE course
Date: 11 September – 4 December 2024
Venue: On-line
Cost: £750
Course leaders: The tutors are experienced Imperial CTU staff working in Clinical Trial Statistics, Methodology, Operations and Clinical Data Systems.

The Imperial Clinical Trials Unit is pleased to announce that registration for the first annual ICTU Contemporary Clinical Trials ONLINE Course is open. The course will run from 11-Sep-2024 to 04-Dec-2024. The online tutorials will take place on Wednesdays 12:00 to 13:30 on MS Teams.

This is a bespoke online course which promotes networking and provides early career researchers with the opportunity to learn the essential skills needed to plan and conduct a clinical trial and to develop a research protocol with support from experienced ICTU staff working in Clinical Trial Statistics, Methodology, Operations and Clinical Data Systems. The cost is £750 per delegate.

You can register here: All enquiries should be sent to icctstats@imperial.ac.uk.

Title: Adaptive methods in clinical trials
Date: 17 – 19 September 2024
Venue: Cambridge
Cost: Delegates (commercial) £900; (non-commercial) £590; (external students) £499
Course tutors: Prof Thomas Jaki, Dr Sofia Villar, Dr David Robertson, Dr Pavel Mozgunov, and Dr Martin Law – MRC Biostatistics Unit, University of Cambridge

Many confirmatory clinical trials turn out to be negative and do not lead to the registration of a new drug or the introduction of a new treatment. Consequently, there is growing interest amongst clinical researchers in the use of efficient methods for conducting early and late phase trials to identify the most promising compounds, and in using interim analyses to allow trials to be stopped as soon as there is sufficient evidence to reach a convincing conclusion.

Adaptive designs allow mid-trial modifications to be made to the trial so that the accumulating data guides investigators to the most appropriate form of evaluation. While offering great flexibility during the trial, they require specialised approaches to be designed and analysed.

In this course, we are going to introduce the definition of adaptive designs and consider its several most common types that are delivered through a mixture of lectures, practical sessions, and discussions. Specifically, we are going to explore

1. Group Sequential Designs
2. Multi-Arm Multi-Stage Designs
3. Sample Size Re-estimation
4. Response Adaptive Randomisation
5. Master protocols

Throughout the course, the examples of implemented in practice designs that the MRC BSU has contributed to recently will be used to demonstrate the methodology. The workshop will involve practical sessions in R on these designs implementations and discussions on the practical aspects. By the end of the course, you will design your own adaptive trial.

For more details and to register click here.

Title: Introduction to cancer clinical trials
Date: 19 September 2024
Venue: 90 Tottenham Court Road, W1T 4TJ
Cost: For-profit organisations – £100; Non-profit organisation – £50
Course lead: Giulia Pellizzari, Lecturer, CRUK & UCL CTC

This session provides a general introduction to cancer clinical trials for staff new to academic cancer studies. It will run between 10:00 and 13:00.

Participants will get an overview on what clinical trials are and how they can have a preventative, curative or palliative aim. The session covers the practical and scientific reasons why we need clinical trials, what are the differences between Phase I, II, II and IV studies and the different methods of randomisation. The session also highlights how drug development trials in cancer differ from non-cancer studies and how the new era of targeted therapy and immunotherapy is changing the way cancer trials are designed.

For further details, and to register, click here.

Title: Foundations of Cluster Randomised Trials
Date: 23 – 25 September 2024 (3-day course) or 23 – 27 September 2024 (5-day course)
Venue: Online
Cost: £300 (3-day course) £450 (5-day course)

This short 3-day or 5-day on-line course will provide training in the design, conduct and analysis of cluster randomized trials (CRTs) and stepped-wedge cluster randomized trials (SW-CRTs). Delivered by faculty of the University of Birmingham including Karla Hemming, Sam Watson and James Martin and a guest speaker.

These trials are increasingly used to evaluate interventions that improve care delivery and study strategies for implementing efficacious interventions in routine clinical practice. They require specific methods of design and statistical analysis. This course will include the rationale for using these designs, specific design issues, the randomisation process, practical issues in managing these trials, and trial reporting and interpretation. Over an optional two days, students also have the opportunity to learn about  sample size calculations and analytical methods. Principals will be illustrated using case studies of stepped-wedge and cluster randomized trials.

Please contact k.hemming@bham.ac.uk for more information or visit https://shop.bham.ac.uk/conferences-and-events/cpd/cpd-courses/foundations-in-cluster-randomised-trials to register.

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October 2024

Title: Running a trial from concept to completion
Date: 3 October 2024
Venue: 90 Tottenham Court Road, W1T 4TJ
Cost: For-profit organisations – £100; Non-profit organisation – £50
Course lead: Rubina Begum, Senior Project Manager, CRUK & UCL CTC

This session gives an introductory overview of all the steps required to design, set up and complete an academic cancer trial conducted in the hospital setting. It will run from 10:00 to 13:00.

Participants will know what all the organisations and people involved in trials do and what permissions and documents need to be in place at different stages of a trial. The course is of most interest to those new to working in academic cancer clinical trials. Those currently working in the field who would like to gain an overview of what happens at other stages to the one familiar to them, may also benefit.

For further information, and to register, please click here.

A meeting for data management and IS staff working in one of the Network’s registered CTUs. This event will showcase some of the exciting work being undertaken around the Network, as well as offering opportunities to share experiences and expertise.

Themes for this meeting include the complexities of running a trial abroad, an agile approach to an eDC build and validation, and communicating functionality to trial teams. An informal networking event will also be held on the evening of 16 October 2024.

Registration will be managed via the Network Secretariat.

Title: Entering patients into cancer clinical trials
Date: 21 October 2024
Venue: 90 Tottenham Court Road, W1T 4TJ
Cost: For-profit organisations – £100; Non-profit organisation – £50
Course lead: Laura Hughes, Trial Manager, CRUK & UCL CTC

This session gives a comprehensive overview of the clinical pathways cancer patients can take to be eventually referred for trial entry. It will run from 10:00 to 13:00.

The first part of the session spans across the diagnostic methods and staging of cancer and gives a brief overview of the common tests carried out prior to trial treatment. In the second part of the session participants will learn about the importance of ensuring only eligible patients enter a trial and how eligibility criteria help to safeguard patients and differ amongst different phases of trials. They will also learn the importance of assessing treatment compliance and how every clinical intervention comes with a different set of challenges in collecting data about patient compliance.

For further information, and to register, please click here.

Title: Response-Adaptive Methods for Clinical Trials
Date: 23 – 24 October 2024
Venue: Cambridge
Cost: Delegates (commercial) £500; (non-commercial) £380; (external students) £200
Course tutors: Dr Sofia S. Villar, D. David Robertson, and PhD student Lukas Pin

Recent high-profile clinical trials have used a response-adaptive procedure as the way to implement an “adaptive” experiment. Such response-adaptive designs allow a variety of mid-trial modifications to be made to the trial so that the accumulating data guides investigators to the most appropriate form of evaluation (e.g. they can be used for arm selection, arm dropping, or simply to assign more patients on average to a superior treatment where possible). While offering great flexibility during the trial, they require specialised approaches for both the trial design and analysis.

Consequently, there is growing interest amongst clinical researchers and the clinical trials community in the use of these methods for conducting either early or late phase trials that more efficiently or more accurately balance competing goals, while gathering sufficient evidence to reach a convincing conclusion.

In this course, we will start from the definition of response-adaptive designs and consider several important aspects of their design and analysis. These concepts will be delivered through a mixture of lectures, practical sessions, and discussions.

Specifically, we are going to explore:

1. Types of response-adaptive allocation procedures
2. Design and analysis considerations
3. Implementing response-adaptive designs (targeting an unequal ratio)
4. Discussion of case studies

For further information and to register click here.

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November 2024

Title: An Introduction to Design and Analysis of Clinical Trials: Statistics for Non-Statisticians
Date: 4 – 7 November 2024
Venue: Online
Cost: £135 Low Middle Income Countries (LMIC); £259 Academic / attendees from not-for-profit organisations; £338 Attendees from for-profit organisations
Course Facilitators: Laura Murphy & Roisin Connon (MRC CTU at UCL)

This four day course will provide an introduction to the principles and application of statistics in the randomised controlled trial (RCT) environment. It will explain what’s important and why, and enable understanding of statistical methods and analyses in RCTs.

INTENDED AUDIENCE
Non-statisticians working in clinical trials who only have a basic level of statistical knowledge at present and wish to be more familiar with the meanings of common statistical terms used in clinical trials and the interpretation of results. Generally this course is aimed at people with less than 3 years’ experience in a Clinical Trials setting, although all applicants are welcome.

PROGRAMME CONTENTS

• Basic descriptive statistics (refresher)
• Estimation and hypothesis testing
• Outcomes measures used in clinical trials
• Study design and randomisation
• Sample size calculations
• Survival analysis

For more information and to register, please visit: https://www.ucl.ac.uk/clinical-trials-and-methodology/education/short-courses/statistics-for-non-statisticians

The course introduces the key considerations when designing and conducting a randomised clinical trial. The course is split into two Modules: Module 1 is Trial Design and Module 2 is Trial Conduct.  During Module 1, delegates will learn why clinical trials are necessary, how different kinds of trials are designed and how bias can be minimised.  Module 2 includes how trials are managed and then analysed, interpreted and reported.  Delegates can choose to attend just one Module or both.  Neither Module will consider non-randomised trials or other observational designs, or trials evaluating diagnostic tests.  We will primarily focus on large multi-centre clinical trials, considering both drug and complex intervention trials.

The course is offered solely online via Microsoft Teams over a 4-week period (2 weeks per Module). During this time, delegates will have access to all course materials, including pre-recorded slides and additional activities.  Course materials will be accessible prior to the start of the course date and can be accessed at any point enabling delegates to learn at a time that is convenient to them.  Each module comprises a variety of sessions each of which has an organised “live” session with a course tutor.  These are organised sessions that all delegates are encouraged to attend, though attendance is not mandatory.  You will be notified of live session dates in advance.  Live sessions offer delegates an opportunity to talk directly to the course tutor and other delegates, ask questions they may have about the content they’ve accessed and explore activity content. Although the course is spread over 4 weeks, a lot of content is included. You should therefore ensure you have sufficient time to be able to access pre-recorded materials and attend as many of the live sessions as possible.

For more details, and to register, visit www.nctu.ac.uk/short-courses/online-introduction-to-clinical-trials.aspx.

Who is this for?
All welcome. It would be of special interest to potential investigators who would be working with us in the next 12 months to put together a grant application, anyone who is new to research or wants to know how the Centre for Trials Research (CTR) works.

Delivered by
Nigel Kirby – Head of Data Management, Debbie Harris – Senior Data Manager for the Infection, Inflammation and Immunity Division, Ceri Frayne – Senior Data Manager for the Cancer Division, Helen Stanton – Senior Data Manager for the Population Health and Social Care Division, Mia Sydenham – Senior Data Manager for the Brain Health and Mental Wellbeing Division

Abstract:
High Quality Data Management is fundamental to the running of any research study. Research is all about good data. to be able to have confidence in your data then you need to have quality data management. This includes setting up validated systems to capture the data, ensuring all legal and ethical frameworks have been considered and considering how data will be captured, stored, preserved and archived. This webinar will provide insight on the importance of the Data Management function and give some examples of good practice from current CTR studies.

To register, please click here.

Title: Cancer treatments and their side-effects
Date: 7 November 2024
Venue: 90 Tottenham Court Road, W1T 4TJ
Cost: For-profit organisations – £100; Non-profit organisation – £50
Course lead: Giulia Pellizzari, Lecturer, CRUK & UCL CTC

This session is a basic introduction to cancer treatments and their most common side-effects and adverse reactions. It will run from 10:00 to 13:00.

The course provides an overview on cancer surgery, radiotherapy and chemotherapy we well as insights on the mechanisms of action of targeted therapies such as monoclonal antibodies, small inhibitory molecules, CAR-T cell therapy and immune checkpoint inhibitors.

In the second part of the session, participants will learn about the mechanisms of toxicity linked to the different categories of cancer therapy and how these are managed.

This course is not recommended for clinicians.

For further information, and to register, please click here.

Title: Introduction to Cancer Clinical Trials for Statisticians
Date: 12 – 13 November 2024
Venue: 90 Tottenham Court Road, W1T 4TJ
Cost: Non-commercial £350 (early bird rate only available until 16 September 2024)

A two-day course to introduce delegates to the biology, diagnosis, staging, and treatments of cancer and how these relate to the main outcome measures used in cancer clinical trials (adverse events, response, survival, quality of life and other time-to-event endpoints).

Target audience
This is an introductory course suitable for recent MSc graduates or more experienced statisticians new to the field of cancer treatment trials.

Delegates do not need to have prior knowledge of cancer.

Course lectures

• An introduction to cell and cancer biology and how these impacts on choice of treatment, tumour spread and outcome measures
• A detailed view of cancer diagnosis and staging and how these impact on pre-trial entry screening tests and eligibility criteria
• Commonly reported patients and tumour characteristics and issues in choosing appropriate stratification factors for cancer patients
• Outline of traditional and innovative cancer treatments
• A detailed overview of the mechanisms of toxicity expected with different cancer treatment categories
• Summary of adverse event reporting categories
• Outcome measures and response criteria in solid tumours and haematological malignancies
• Issues in survival and time to event analyses
• Challenges and opportunities of new generation of cancer trials

Opportunities

• Discussions and Q&A sessions – an opportunity for you to ask questions and for the lecturers to help you with your specific needs.
• Interactive quizzes for you to test your newly acquired knowledge
• Two workshops – an opportunity for you to turn theory into practice and for networking

For more information, and to register, click here.

Title: Bayesian Statistics Short Course
Date: 15 – 19 November 2024
Venue: On-line
Cost: Commercial £500; Academic £380; Students £200
Course tutors: Dr Anne Presanis, Dr Robert Goudie & Dr Christopher Jackson – MRC Biostatistics Unit

Course aims
This short course introduces students to Bayesian statistical methods in biomedical settings, and provides skills for designing, assessing and interpreting Bayesian analyses using the R and JAGS statistical software. The emphasis throughout will be on practical, applied modelling: code to carry out analyses will be provided.

Course outline
The course runs on the Moodle online learning platform, and involves 7 sessions:
1.    Quantifying uncertainty with probability
2.    Bayesian inference
3.    Bayesian regression models
4.    Critiquing and comparing Bayesian models
5.    Hierarchical models
6.    Modelling with missing and censored data
7.    Integrating multiple sources of data

Course delivery
The course will be delivered via the Moodle online learning platform. The course consists of 7 half-days worth of content, and will take place over 7 half-days across 3 weeks starting on Friday 15th November 2024. It will consist of some on-demand content and some timetabled (live) sessions.

For further details, and to register, visit https://onlinesales.admin.cam.ac.uk/conferences-and-events/mrc-biostatistics-unit/mrc-biostatistics-unit-short-courses/bayesian-statistics-online-short-course-november-2024.

Title: Design and analysis of precision medicine trials
Date: 18 – 19 November 2024
Venue: Newcastle University Main Campus, Newcastle upon Tyne
Cost: Student: £320; Academic/public sector/alumni of Newcastle University: £425; Private sector: £640
Course tutors: Dr Svetlana Cherlin & Prof James Wason (Newcastle University), Dr Haiyan Zheng (MRC Biostatistics Unit)

Course description
Precision medicine is about going beyond assessing whether a new treatment works on average to predicting which subgroups of patients receive benefit and to what extent.  When subgroups (often defined by biomarkers, genetic, phenotypic or psychosocial characteristics, etc.) are associated with a treatment’s efficacy or toxicity, precision medicine offers substantial advantages to patients, trial sponsors, and the wider healthcare system. However, a barrier to realising the promise of precision medicine is the inappropriate use of traditional clinical trial design and analysis, which rely on estimates of population-averaged effects.

In this course we introduce the concept of precision medicine and a range of innovative approaches. This includes novel statistical designs proposed for biomarker-guided, basket, umbrella, adaptive signature, adaptive enrichment designs and Sequential Multiple Assignment Randomized Trials, as well as the accompanying efficient analysis approaches building upon (i) Bayesian hierarchical modelling, and (ii) identifying patient subgroups using high-dimensional genetic data, to help estimate subgroup-specific treatment effects. These approaches have all been developed to improve the statistical power, quality of information, and patient benefit provided by clinical trials. Examples from a wide variety of therapeutic areas will be discussed, with implementation in R software. Perspectives will be given on the future development of design, conduct and analysis of clinical trials in the field.

More details at: https://www.newcastle-biostatistics.com/courses/precision_trials/

Intended Audience
Students and professionals with some knowledge of clinical trials and statistics are welcome.  Statisticians will benefit the most from this course. Clinicians and trialists with good knowledge of statistics and computing will follow much of the course and will be exposed to a range of potential new methods. With the practical sessions, participants will have a chance to implement the novel methods in concrete examples. Though for some of the course material a good knowledge of statistical theory or R software would be helpful, the curriculum would try to accommodate a wide range of statistical and programming knowledge.

Prerequisites
Some basic knowledge of R (although full support given), knowledge of clinical trials and basic statistics. For some parts of the course, preliminary knowledge of Bayesian statistics is required.

Computing Practicals
Each lecture will have a computer practical in R. Most of the practicals will be possible to do without advanced knowledge of R as guidance will be given.

Participants need to bring a laptop with R and JAGS installed. Basics of Markov chain Monte Carlo would be mentioned only very briefly during the course. Participants will gain most from the practicals if they already have a working knowledge of R.

To register, see: https://webstore.ncl.ac.uk/short-courses/faculty-of-medical-sciences/population-health-sciences-institute/design-and-analysis-of-precision-medicine-trials-2024

Title: How to design clear and accessible Patient Information Sheets
Date: 19 November 2024
Venue: On-line
Cost: Delegates (commercial) £100; (non-commercial) £50
Course tutors: Linda Von Neree, Patient and Public Involvement and Engagement (PPIE) Lead, BRTU PPI Lead and Giulia Pellizzari, PhD, Lecturer/Education Lead, CRUK & UCL Cancer Trials Centre.

Patient Information Sheets (PIS) are a key document for potential participants to make an informed decision about whether to take part in a clinical study. While there is clear guidance from the Health Research Authority (HRA) on content and regulatory requirements, PIS are customised for each clinical trial and the specific patient population. Choosing the right language and format for patient facing materials for research studies and clinical trials still greatly varies and depends on the skills and experience of the team putting them together.

In this workshop attendees will gain useful insights on how to work on the format, language and delivery of the PIS thanks to the participation of patient representatives with experience in clinical trials of different phases and with different clinical interventions. The session includes an initial overview of the HRA guidance on the PIS design, an introduction to writing in plain English and a patient’s perspective in providing consent to a clinical study, followed by group work where research staff will go into virtual breakout rooms with Patient and Public representatives to review together a PIS that will be provided to the attendees a week prior to the course. Most importantly, at the end of the course, participants will be provided with a “PIS Checklist”: a memorandum of the considerations to take into account when designing (or reviewing) a Patient Information Sheet.

Speakers:
• Clinical Trial Managers and Researchers
• Patient and Public Partners
• Linda von Nerée, PPIE Associate – CRUK & UCL CTC
• Giulia Pellizzari, UCL Lecturer & Education Lead – CRUK & UCL CTC
• Rubina Begum, Senior Project Manager – CRUK & UCL CTC

To register for this course, please click here.

Title: A practical introduction to running randomised clinical trials
Date: 19 – 22 November 2024
Venue: On-line
Cost: Delegates (commercial) £699; (non-commercial) £599; Students £499
Course leaders: Professor Ed Roddy, Professor Mel Holden, Professor Martyn Lewis

Keele School of Medicine and CTU is running a 4-day virtual short course in November to improve participants’ knowledge and skills in the design, practical conduct, management and analysis of randomised clinical trials (RCTs). Combining talks and workshop activities, you will be guided through the principles, methodology and practical implementation of RCTs. 

The course is aimed at individuals who are planning to undertake or are undertaking clinical trials. This includes people with no previous clinical trials experience, those embarking on clinical trial research for the first time, or those who have some experience of designing and running trials. We welcome attendees with clinical (including allied healthcare professionals) or non-clinical (including trial managers & R&D managers) backgrounds. The course is suitable for individuals interested in clinical trials in a variety of settings including primary care, the primary/secondary care interface and secondary care. 

For enquiries please email: Rachael Heath (r.a.heath@keele.ac.uk) 

To register for this course, please visit the following weblink:   www.keele.ac.uk/primary-care-short-courses/runningrandomisedclinicaltrials

Title: Statistical and practical aspects of the design and analysis of Multi-Arm Multi-Stage (MAMS) Platform Trials
Date: 20 November 2024
Venue: On-line (Zoom)
Course facilitators: Dr Babak Choodari-Oskooei, Professor Mahesh Parmar, Professor Matt Sydes

This ICTM workshop is aimed at trial statisticians, regulators and clinicians who want to understand more about the design and analysis of multi-arm multi-stage (MAMS) platform trials, or those who are new to the area.

There will be an opportunity for delegates to send questions in advance so that they can be addressed at the workshop.

The workshop aims to help participants:

• Understand the motivation behind these designs
• Learn how to choose the design parameters and stopping boundaries, both for lack-of-benefit and efficacy
• Learn how to deal with overwhelming efficacy
• Learn about stopping randomisation to research arm
• Learn how to add a new research arm, and how to control Type I and II error rates in both pre-planned and unplanned addition of a new research arm
• Learn about MAMS designs in which arms are ranked and selectively chosen to continue
• Learn how the programs written in Stata software can be used to design MAMS trials with time-to-event and binary outcomes

For further information, and to register, visit: www.ucl.ac.uk/clinical-trials-and-methodology/education/short-courses/gmp-for-imp.

This one-day online workshop led by the Centre for Trials Research at Cardiff University is intended for chief investigators working on, or planning, their first large-scale clinical trial with a CTU.

Delegates will hear from clinical trials unit staff about optimal trial delivery and gain insights and peer support from a wide range of experienced Chief Investigators. They will also learn about the wider clinical trials landscape including the funder perspective, mentoring, patient and public involvement, and equality diversity, and inclusion.

Find out more and secure your place here.

Title: Edinburgh Clinical Trial Management Course
Date: 21 & 22 November 2024
Venue: John McIntyre Conference Centre, Edinburgh
Cost: NHS/Academic rate = £550; Optional course dinner (21 Nov 2024) = £35; Industry rate (inc. dinner) = £985

This course has been running for more than two decades, in order to support the professional development of anyone involved or interested in clinical trial management, including Trial Co-ordinators, Trial Management Support Officers (TMSO), Assistant Trial Managers (ATMs), Trial Managers (TMs), Senior Trial Managers (STMs) and related roles.

The aims of the course are:

• To develop attendees’ knowledge and skills in clinical trial management.
• To improve attendees’ understanding of related disciplines including research governance, regulation, trial methodology, data management, monitoring, and project management, with a view to effective teamworking.
• In 2024, there will be a particular focus on patient and public involvement and engagement (PPIE) in trials, efficiency in trial conduct, trial manager career progression, participant diversity, and sustainability in trial conduct.

The course consists of a variety of workshops, practical tasks and lectures. Several interactive sessions cover key topics associated with setting up and delivering clinical trials. Sessions provide practical guidance and facilitate discussion, information exchange and provide plenty of networking opportunities adjacent to Arthur’s Seat, a mountain in the heart of Edinburgh.

The course is co-delivered by The Universities of Edinburgh and Aberdeen.

The three gold threads of the course in 2024 are:

1. Patient and Public Involvement and Engagement (PPIE)
2. Efficient trial design
3. Sustainability

For further information, and to register, visit: https://edin.ac/4c7WJ9N.

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Title: GMP for IMP
Date: 27 November 2024
Venue: Online
Cost: £193 Low Middle Income Countries (LMIC); £385 UCL staff, students & alumni; £462 External delegates
Course Facilitator: Jo Burmester

This training will provide participants with an understanding of the legislation and guidance covering manufacture and handling of investigational medicinal products in the EU.

The main document we focus on is Annexe 13 of Eudralex Volume 4 which covers requirements for manufacture of medicinal products specifically for use in a clinical trial setting. We also consider key GMP changes coming with the new EU Clinical Trials Regulation and associated guidelines and cover the EU Guideline on IMPs and Non-IMPs – soon to be updated to Auxiliary Medicinal Products. We include an interactive workshop session looking at Site Management of IMP: Personnel, Premises and Processes.

This course is suitable for anyone involved in manufacture and/or management of Investigational Medicinal Products in clinical trials, for example: Clinical Project Managers, CRAs, CTAs, Clinical Trial Pharmacists, Contract Manufacturers.

For more information and to register, please visit: https://www.ucl.ac.uk/clinical-trials-and-methodology/study/short-courses/gmp-imp

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December 2024

Title: Trial outcomes: What are we trying to measure?
Date: 2 December 2024
Venue: 90 Tottenham Court Road, W1T 4TJ
Cost: For-profit organisations – £100; Non-profit organisation – £50
Course lead: Will Wilson, Statistician, CRUK & UCL CTC

This session, aimed at non-statisticians, will cover the most common primary outcomes measures used in early and late phase cancer trials. It will run from 10:00 to 13:00.

Participants will learn what makes a good outcome measure, how outcomes measures are defined and what data need to be collected to assess the outcome, especially for tumour response assessment and time to event measures such as survival and disease (or progression) free survival.

For further information, and to register, please click here.

The course introduces the key considerations when using qualitative methods in clinical trials. Throughout the three-day course, delegates will learn about the theory, relevance and value of qualitative research in all stages of a clinical trial as well as gain an appreciation of different types of qualitative methodology used in clinical trials. We will primarily focus on clinical trials but will also consider qualitative research as part of feasibility studies that can be used to test interventions in preparation for a large clinical trial. 

By the end of the course, participants should:

• Understand how qualitative research can complement trial methodology at all stages of clinical trials
• Appreciate specific methodological issues such as ethical requirements and sampling challenges when designing qualitative research
• Appreciate how to generate, manage and analyse qualitative data in a clinical trial
• Understand reporting requirements for qualitative research conducted as part of a clinical trial

The course will incorporate a range of activities (individual, didactic, and small group) and discussion to allow students to practice and enact learning.

For further information, and to register, please click here.

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January 2025

Title: Independent Data Monitoring Committee
Date: 14 – 16 January 2025
Venue: Online
Cost: Academic/attendees from not-for-profit organisations £354; Attendees from for-profit organisations £425; Delegates resident in low middle income countries – £177

Do you or will you sit on IDMC or have a publicly funded trial that needs to be overseen by an IDMC?

If so, this popular course is for you, whether you are a clinician, statistician, or work in trial operations.  The multidisciplinary Faculty will lead participants through many of the challenges and complex issues associated with reviewing accumulating data from clinical trials and making recommendations.  The course covers the practical and statistical issues that you need to consider when setting up and running an IDMC.  Using lectures, group discussions, and real-life case studies the course covers: roles and responsibilities of an IDMC, best practice, membership, the need for independence, and decision-making, recommendations and relationships to other committees.

We are particularly keen on receiving applications from clinicians, but if you could circulate amongst your teams, that would be great. 

For more information and to register, please visit:  https://www.ucl.ac.uk/clinical-trials-and-methodology/education/short-courses/idmc

Title: Practical Use of Multiple Imputation to Handle Missing Data in Stata
Date: 28 – 29 January 2025
Venue: 90 High Holborn, 2nd Floor, London WC1V 6LJ
Cost: Low Middle Income Countries (LMIC) – £185; Academic, students & external not for profit organisations – £370; External for profit organisations – £444
Course facilitators: Ian White and Tim Morris (MRC Clinical Trials Unit, UCL), and Angela Wood (University of Cambridge)

Course Overview:
Our aim in this course is to provide participants with the ability to analyse their own data using multiple imputation, but also to be aware of the pitfalls and limitations of the technique. We will give plenty of practical examples from our own experience of analysing data in medical research. We welcome participants bringing their own data and problems, and one session is dedicated to discussion of some participants’ data.

Who Should Attend:
The target audience for this course is researchers needing to analyse incomplete data:
• Attendees are expected to be familiar with running Stata from the command line (i.e. not using menus) at least to the level of fitting a regression model to complete data and producing simple graph
• No prior knowledge of multiple imputation is assumed.
• Participants will need a computer with the facility to run Stata 12

Requirements:
• Laptop with Stata 12 or higher
• Download course datasets before the course

Structure:
Two mornings (09:00-13:00), featuring nine lectures and eight practical sessions.

For more information and to register, please visit: https://www.ucl.ac.uk/clinical-trials-and-methodology/education/short-courses/missing-data

Title: Masterclass in the Design & Conduct of Complex Intervention Evaluations
Date: 29 January, 5 February, and 12 February 2025
Venue: Online
Cost: Early bird rate of £475 until Friday 20th December 2024, £525 for registrations after this date.
Course leaders: Michelle Collinson, Alexandra Wright, Hughes, Florence Day, Bethan Copsey & Professor Amanda Farrin, Leeds CTRU

Overview

Many health and social care interventions are complex and require careful consideration of key methodological challenges to enable robust evaluation. This workshop will provide attendees with a clear understanding of how to design and conduct a complex intervention evaluation and will include:

What makes an intervention complex?
• An overview of existing frameworks
• The role of pilot and feasibility studies
• Trial design for complex intervention evaluation
• Intervention implementation and the role of a process evaluation
• Practical considerations in the set-up and delivery of complex intervention trials

Who will benefit from this masterclass?

Clinicians, Health Professionals, Researchers, and NIHR Academy Members interested in planning or leading the design and conduct of evaluations of complex interventions.

Attendees should already have a good working knowledge of clinical trials and be keen to understand the challenges which are specific to evaluating complex interventions.

The masterclass is not suitable for those seeking an introduction to clinical trial design

Book online: https://tinyurl.com/5657k6ae

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March 2025

Title: Introduction to Cancer Clinical Trials
Date: 24 March 2025 (10am – 1pm)
Venue: CRUK & UCL Cancer Trials Centre, 90 Tottenham Court Rd, London
Cost: Non-profit Organisations – £50; For Profit Organisations – £100
Course lead: Giulia Pellizzari, Lecturer, CR UK & UCL CTC

This session provides a general introduction to cancer clinical trials for staff new to academic cancer studies.

Participants will get an overview on what clinical trials are and how they can have a preventative, curative or palliative aim. The session covers the practical and scientific reasons why we need clinical trials, what are the differences between Phase I, II, II and IV studies and the different methods of randomization. The session also highlights how drug development trials in cancer differ from non-cancer studies and how the new era of targeted therapy and immunotherapy is changing the way cancer trials are designed.

For more information, and to register, please click here.

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April 2025

Title: Running a trial from concept to completion
Date: 28 April 2025 (10am – 1pm)
Venue: CRUK & UCL Cancer Trials Centre, 90 Tottenham Court Rd, London
Cost: Non-profit Organisations – £50; For Profit Organisations – £100
Course lead: Rubina Begum, Senior Project Manager, CR UK & UCL CTC

This session gives an introductory overview of all the steps required to design, set up and complete an academic cancer trial conducted in the hospital setting.

Participants will know what all the organisations and people involved in trials do and what permissions and documents need to be in place at different stages of a trial. The course is of most interest to those new to working in academic cancer clinical trials.  Those currently working in the field who would like to gain an overview of what happens at other stages to the one familiar to them, may also benefit.

For more information, and to register, please click here.

Title: Methods for Evaluating Models, Tests and Biomarkers (MEMTAB) international conference
Date: 29 April – 1 May 2025
Venue: University of Birmingham, UK
Cost: Student £300, Academic £500, Industry £750

Website: MEMTAB 2025: “Methodology That Stands the Test” 

MEMTAB is the leading international conference about methods to evaluate models, tests & biomarkers for healthcare. It allows debate & dissemination of best methods for developing, evaluating & identifying reliable models, tests & biomarkers for use in clinical practice.  

In 2025, for our 7th International conference, we return to the University of Birmingham and raise the conference theme: “Methodology That Stands the Test”. 

We want participants to push our understanding of what constitutes the research evidence needed for models, tests and biomarkers to be reliably endorsed, communicated and deployed in practice. 

Registration and abstract submission is now open. Deadline for abstracts is 12^th January 2025.  

For enquiries, email memtab@bham.ac.uk

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May 2025

Title: Entering patients into cancer clinical trials
Date: 15 May 2025 (10am – 1pm)
Venue: CRUK & UCL Cancer Trials Centre, 90 Tottenham Court Rd, London
Cost: Non-profit Organisations – £50; For Profit Organisations – £100
Course lead: Laura Hughes, Trial Manager, CR UK & UCL CTC

This session gives a comprehensive overview of the clinical pathways cancer patients can take to be eventually referred for trial entry.

The first part of the session spans across the diagnostic methods and staging of cancer and gives a brief overview of the common tests carried out prior to trial treatment. In the second part of the session participants will learn about the importance of ensuring only eligible patients enter a trial and how eligibility criteria help to safeguard patients and differ amongst different phases of trials. They will also learn the importance of assessing treatment compliance and how every clinical intervention comes with a different set of challenges in collecting data about patient compliance.

For more information, and to register, please click here.

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June 2025

Title: Cancer treatments and their side-effects – Compliance & Adverse Event Reporting
Date: 9 June 2025 (10am – 1pm)
Venue: CRUK & UCL Cancer Trials Centre, 90 Tottenham Court Rd, London
Cost: Non-profit Organisations – £50; For Profit Organisations – £100
Course lead: Giulia Pellizzari, Lecturer, CR UK & UCL CTC

This session is a basic introduction to cancer treatments and their most common side-effects and adverse reactions.

The course provides an overview on cancer surgery, radiotherapy and chemotherapy we well as insights on the mechanisms of action of targeted therapies such as monoclonal antibodies, small inhibitory molecules, CAR-T cell therapy and immune checkpoint inhibitors.

In the second part of the session, participants will learn about the mechanisms of toxicity linked to the different categories of cancer therapy and how these are managed. This course is not recommended for clinicians.

For more information, and to register, please click here.

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July 2025

Title: Trial outcomes: what are we trying to measure?
Date: 3 July 2025 (10am – 1pm)
Venue: CRUK & UCL Cancer Trials Centre, 90 Tottenham Court Rd, London
Cost: Non-profit Organisations – £50; For Profit Organisations – £100
Course lead: Amy Kirkwood, Principal Statistician – Cancer Trials (Associate Professor) / Will Wilson, Senior Research Fellow – Senior Medical Statistician

This session, aimed at non-statisticians, will cover the most common primary outcomes measures used in early and late phase cancer trials.

Participants will learn what makes a good outcome measure, how outcomes measures are defined and what data need to be collected to assess the outcome, especially for tumour response assessment and time to event measures such as survival and disease (or progression) free survival.

For more information, and to register, please click here.

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