NIHR Statistics Group – Early Phase Clinical Trials Meeting

53 Edgbaston Park Road, B15 2RS, Birmingham, Edgbaston Park Hotel, Location Edgbaston Park Hotel, University of Birmingham
Thursday 28th February 2019 (09:30-16:00)
Download the date to your calendar (.ics file)

For further information, please contact Dr Christina Yap (local meeting organiser, or Dr Simon Bond (section head,

Register for this event

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.

The event is free with lunch and refreshments provided. It is expected to be very popular and there are limited places available.

Registration will close on 10th January 2019.

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 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 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)    TBC

(3)    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