Date: Wednesday 20th November 2024
Time: 12:00-17:00 GMT
Location: Online via Zoom
Course facilitators: Dr Babak Choodari-Oskooei, Professor Mahesh Parmar, Professor Matt Sydes
To register for this workshop, please click here.
• 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 arm
• 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 research 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 three 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 this workshop, 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.
