Registration closes today (10th January 2019). Limited spaces left.

The next workshop of the NIHR Early Phase Clinical Trials group will be held on 28th February 2019 at University of Birmingham.


This meeting will bring together statisticians, clinicians, trial managers and regulator to discuss recent advances in the practical implementation of efficient model-based dose-finding designs in early phase trials. It will also cover exciting and innovative real-world multi-arm early phase I/II platform designs in action.

Data and Time
28th February 2019
9:30am - 4:00pm

Location
Edgbaston Park Hotel,
University of Birmingham,
53 Edgbaston Park Road,
Birmingham,
B15 2RS

Registration
The event is free with lunch and refreshments provided. It is expected to be popular and there are limited places available. Please see draft programme below.
Please register at https://www.birmingham.ac.uk/university/colleges/mds/events/2019/02/NIHR-early-phase-clinical-trials-meeting.aspx.

Draft Programme

09:30 - 09:45 Registration and coffee/tea/pastries



09:45 - 09:50 Introduction and welcome



09:50- 10:30 Life Journey of a Phase I Continual Reassessment Method Trial: Design, Conduct and Reporting

Speaker: Dr Christina Yap, Reader in Biostatistics and Clinical Trials, Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham

I will recount the challenges, heartaches, lessons learnt, and the joys of developing and implementing my first Continual Reassessment Method (CRM) trial, VIOLA, from initial conception to final publication (Yap et al 2017, Craddock et al, in press). Would I do it again?



10:30 - 11:00 CRMs from a clinician perspective: Continual Reassessment or Continual Stress

Speaker: Dr Graham Collins, Haematology consultant and lymphoma lead, Oxford University Hospitals

How statisticians and clinicians approach CRM models can be very different. This talk seeks to explain a clinician perspective - the benefits the model can give in enabling a swifter and more efficient design, but also the possible added stresses. I will mainly use the RomiCar trial as the basis for discussion. The aim is to foster understanding between clinicians and statisticians in order to enable better team working.



11:00 - 11:15 Refreshment Break



11:15 - 12:15 Examples of Early Phase Multi-arm (Platform) Designs in Action


(1) Precision Panc: Personalising Treatment for Pancreatic Cancer
Speaker: Dr David Chang, Reader and Honorary Consultant Pancreatic Surgeon, University of Glasgow


(2) Practical challenges of delivering a platform trial from a trial management perspective
Speaker: Ms Claire Snowdon, Deputy Director & Operations Director, ICR Clinical Trials & Statistics Unit, The Institute of Cancer Research



12:15 - 13:15 Regulatory perspective of early phase I/II designs, including basket, umbrella and platform designs

Speaker: Dr Khadija Rantell, Statistical Assessor, Medicines and Health Care Products Regulatory Agency (MHRA)



13:15 - 14:15 Lunch



14:15 - 14:45 Early Phase Statistical Analysis Plan project

Speakers: Mrs Aimee Jackson, Senior Biostatistician and

    Dr Christina Yap, Reader in Biostatistics and Clinical Trials,

    CRCTU, University of Birmingham

A UKCRC Operational Statistics Early Phase Working Group has been set up to develop statistical analysis plans for early phase trials. This will build on recent work for later phase randomised trials (Gamble et al 2017). This interactive session will report on progress so far and aim to capture perspective from delegates.



14:45 - 15:30 Update on past activities. Identify future training courses/projects.

Speaker: Dr Simon Bond, Senior Statistician, Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust



15:30 - 15:50 Closing remarks

Speakers: Drs Simon Bond and Christina Yap

For further information, please contact Dr Christina Yap (local meeting organiser, [log in to unmask]<mailto:[log in to unmask]>) or Dr Simon Bond (section head, [log in to unmask]<mailto:[log in to unmask]>).


This workshop is supported by NIHR Office for Clinical Research Infrastructure and Birmingham Biomedical Research Centre.


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