Workshop: Statisticaland practical aspects of the design, analysis, and conduct of Multi-ArmMulti-Stage (MAMS) Platform Trials 
Organisers: MRC Clinical Trials Unit, UCL Institute of Clinical Trials andMethodology 
Venue: MRC CTU at UCL, 90 High Holborn, London, WC1V 6LJ
Workshop date: 11 December 2019  
Cost: Free (travel not included) 
Potential Attendees: 
This workshop is aimed at researchers who want to understand moreabout MAMS platform trials or those who are new to the area. This includesstatisticians looking to design MAMS platform trials, or clinicians and trialmanagers wanting to understand the statistical issues in designing such trialsin the phase III setting. There will be an opportunity for delegates to sendquestions in advance so that they can be addressed at the workshop. 
Aim of theworkshop:
This workshop will focus on the statistical and practical aspectsin the design, conduct and analysis of such trials. The workshop aims to helpparticipants:   
   - 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 arms
   - 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 arm 
   - learn about MAMS designs in which arms are ranked and selectively chosen to continue

MAMS platformtrials:
Typically, in these protocols, randomisation is stopped toinsufficiently active treatment arms at interim stages and new research armscan be added during the course of the trial. MRC Clinical Trials Unit at UCL isa leader not only in the design, but also in implementation and analysis ofsuch trials.  The MAMS approach is one ofthe few adaptive designs being deployed in a number of trials and across arange of disease in the phase III setting, including STAMPEDE (prostatecancer), CompARE (TB), TRUNCATE-TB (TB), RAMPART (renal cancer), and ROSSINI-II(wound surgery) . 
Structure of theworkshop:
This half-dayworkshop consists of two main sessions. The first session of the workshop provides anoverview of the design issues involved in MAMS platform protocols. The secondsession focuses on the implementation of the statisticalaspects of such trials and provides guidelines on the design andanalysis of such trials. It will also explore further design issues such asadding new research arms, and designs in which research arms are ranked andselectively chosen to continue. 

Software and examples:
In both sessions, the methods are explored using real platform trialexamples, and using programs written in Stata software - i.e. the nstage suite in Stata for trials withcontinuous, binary and time-to-event outcomes, which can be usefully partneredwith artpep for time-to-eventprojections. 
The workshop concludes with a discussion session when participantshave the opportunity to discuss specific design and analysis questions with thepanel. For this reason, we encourage those planning to attend the workshop tosubmit their questions to the above email in advance, any time afterregistration. 

Draft programme: 
   
   - 12:45-13:00 - Registration 
   - 13:00-13:10 - Introduction
   - 13:10-14:20 – Session 1: Multi-arm, multi-stage (MAMS) trials: introduction and design issues
   - 14:20-14:50 - Coffee break 
   - 14:50-16:15 - Session 2: Further design issues of MAMS platform trials 
   - 16:15-17:00 – Panel discussion and conclusion 
Faculty will include: 

|     
   - Mahesh Parmar
  |     
   - Matt Sydes
  |
|     
   - Babak Choodari-Oskooei
  |     
   - Alexandra Blenkinsop
  |


To register: please email Paul Crawley [log in to unmask] providing your name, job title, andname of your institution. The places will be offered on the first come, firstserved basis. 
 
 
Babak Choodari-Oskooei, PhD
Statistician
MRC Clinical Trials Unit at UCL
Institute of Clinical Trials andMethodology 90 High HolbornLondon, WC1V 6LJ
UK Directline:              +44 (0)20 7670-[4706]
Mainswitchboard:      +44 (0)20 7670-4700
Email:                     [log in to unmask]   Website:                  http://www.ctu.mrc.ac.uk/
Follow up on twitter:   https://twitter.com/MRCCTU
 

 


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