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Statistical & practical aspects of the design/analysis of Multi-Arm Multi-Stage Platform Trials

Next Course: 15th June 2022. Course will start from 12pm GST (GMT+1)

Course Facilitator: Dr Babak Choodari-Oskooei

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This 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.

This 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 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

  • Learn how the programs written in Stata software can be used to design MAMS trials with time-to-event and binary outcomes

MAMS platform trials:

Typically, in these protocols, randomisation is stopped to insufficiently active treatment arms at interim stages and new research arms can be added during the course of the trial. MRC Clinical Trials Unit at UCL is a leader not only in the design, but also in implementation and analysis of such trials.  The MAMS approach is one of the few adaptive designs being deployed in a number of trials and across a range of disease in the phase III setting, including STAMPEDE (prostate cancer), CompARE (TB), TRUNCATE-TB (TB), RAMPART (renal cancer), and ROSSINI-II (wound surgery) .

Structure of the workshop:

This half-day workshop consists of two main sessions. The first session of the workshop provides an overview of the design issues involved in MAMS platform protocols. The second session focuses on the implementation of the statistical aspects of such trials and provides guidelines on the design and analysis of such trials. It will also explore further design issues such as adding new research arms, and designs in which research arms are ranked and selectively chosen to continue.

Software and examples:

In both sessions, the methods are explored using real platform trial examples, and using programs written in Stata software - i.e. the nstage suite in Stata for trials with binary and time-to-event outcomes, which can be usefully partnered with artpep for time-to-event projections.

The workshop concludes with a discussion session when participants have the opportunity to discuss specific design and analysis questions with the panel. For this reason, we encourage those planning to attend the workshop to submit their questions to the above email in advance, any time after registration

The panel will consist of Dr Babak Choodari-Oskooei, Professor Max Parmar and Professor Matt Sydes.

Fees

This course is free for staff from Units within ICTM (CRUK-CTC, CCTU, MRC CTU at UCL and PRIMENT) although places are limited. Attendees from outside of the ICTM will be required to pay an attendance fee. Fees are based on the attendee's organisation as follows:

  • £60 for attendees from other UCL departments;
  • £60 for student attendees
  • £60 for attendees from Low Middle Income Countries (LMIC) (first five places free, please email ictm.education@ucl.ac.uk requesting exemption)
  • £120 for attendees from other not-for-profit organisations; and
  • £120 for attendees from for-profit organisations.

The ICTM CPD Administrator will advise successful applicants of the location and fee payment process.

If you have any queries about this course, please contact the ICTM CPD Administrator on ictm.education@ucl.ac.uk