We would like to invite you to the NIHR Statistics Group : Early-phase Trials Research Section Workshop, to be help on 16 February 2018, Rooms 2 & 3, Biomedical Research Centre, 16th Floor, Guy's Hospital Great Maze Pond London SE1 9RT.
Further information and registration page is here https://statistics-group.nihr.ac.uk/event/second-workshop-of-the-nihr-statistics-groups-early-phase-trials-research-section/
Programme Details below:
Morning Session
10:0-10:30 Registration and Coffee
10:30-11:30 Early Phase Trials Group Outputs to date
Sharon Love University of Oxford
Graham Wheeler University College London
Content: We aim to motivate wider use of model-based designs for dose-finding. We have identified perceived barriers and we suggest required changes. We will discuss the continual reassessment method, CRM, in detail giving suggestions on design parameters.
Objectives: During this session you will hear reasons for the lack of use of model based designs and learn some ways round them. With respect to the CRM, you should leave with an idea of one way to parameterise a trial.
11:30 - 13:00 Rare Diseases
Simon Skene University College London
Graham Wheeler University College London
Content: Trials of advanced therapies in rare diseases often have very small sample sizes. This presents several challenges, including how best to design the study. Attendees will be presented with a real trial, and discuss how best to design the study given various constraints.
Objectives: From this, we will develop new work on how best to design future trials that overcome key problems in this area."
13:00- 13:30 Lunch
Afternoon Session
13:30- 14:00 Practical application of dose-response models
Phillip Pullman University of Cardiff
Content: we will demonstrate the functionality of MoDEsT, a free and easy-to-use web tool for designing and evaluating dose-escalation studies, and illustrate the practical workflow when designing and conducting a phase I dose-escalation study with a previously published data example.
Objectives: Enabling clinicians to fully comprehend model-based designs and apply them with confidence, and to try out various design options and watch the changes become visible in real time. Thus tasks that currently discourage people from using model-based designs, like having to formalise prior beliefs, will appear much less daunting.
14:00-14:30 Time-to-toxicity-event trials
Jane Holmes University of Oxford
Content: We will give a brief introduction to the CRM modification TiTE-CRM and give an example of applying this design to a real trial. We will discuss some of the hurdles we faced and how we dealt with them.
Objectives: During this session we will introduce one of the modifications to the CRM design, the TiTE-CRM which is useful in situations where the toxicity period is long ( eg for radiotherapy). Via a real trial example, you will learn of some of the items to consider when using this design.
14:30 -15:30 Five thoughts on early phase trials, Q&A Session
Sharon Love University of Oxford
Simon Bond Addenbrookes Hospital, Cambridge University Hospitals
Content: Have you run model based designs and had to change the way you work on the fly? We give 5 ways in which early phase CRM design trials are different. Forewarned is forearmed!
Objectives: During this session you will find out about some practicalities of running early phase CRM and CRM modification design trials
15:30 - 16:00 Round-up of workshop outputs and action points
Graham Wheeler University College London
Victoria Cornelius Imperial College London
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Dr Simon Bond MA PhD CStat CSci
Senior Statistician
Tel: (+44) (0)1223 596475 | Ext 6475| [log in to unmask] www.cuh.org.uk/cctu
Cambridge Clinical Trials Unit
Cambridge University Hospitals NHS Foundation Trust | Addenbrooke's Hospital|
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The CCTU is part of the NIHR UKCRC Registered CTU Network: This unit receives National Institute for Health Research CTU Support Funding. This funding has been awarded to support the unit in developing and supporting NIHR trials.
The Trust is: part of the National Institute of Health Research - Cambridge Biomedical Research Centre and a member of Cambridge University Health Partners
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