Organisers: MRC Clinical Trials Unit, UCL Institute of Clinical Trials and Methodology
Venue: MRC CTU at UCL, 90 High Holborn, London, WC1V 6LJ
Workshop date: 11 December 2019
Cost: Free (travel not included)
This workshop is aimed at researchers who want to understand more about MAMS platform trials or those who are new to the area. This includes statisticians looking to design MAMS platform trials, or clinicians and trial managers wanting to understand the statistical issues in designing such trials in the phase III setting. There will be an opportunity for delegates to send questions in advance so that they can be addressed at the workshop.
Aim of the workshop:
This workshop will focus on the statistical and practical aspects in the design, conduct and analysis of such trials. The 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
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 continuous, 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.
- 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:
To register: please email Paul Crawley email@example.com providing your name, job title, and name of your institution. The places will be offered on the first come, first served basis.