The Adaptive Designs Working Group (ADWG) of the MRC network of Hubs for Trials Methodology Research are visiting Oxford University on 12 June to conduct an Adaptive Designs Workshop to encourage and support the use of adaptive methods for clinical trials in practice. On the day, Professor Thomas Jaki, Dr Thomas Burnett and Dr Pavel Mozgunov (Lancaster University) shall begin by giving a broad introduction to adaptive designs for clinical trials, why you might consider them, what options are available and some examples of where they have been implemented in real studies. This will be followed by interactive discussions on the design and implementation of adaptive trials that may be of particular interest to you. We encourage participants to share details of any trials that may benefit from an adaptive design or particular methods they wish to discuss before the day, to assist in bringing the greatest benefit to you from this visit. Further to the planned activities members of the ADWG will be available after the main session should you wish to discuss any further collaboration with the group.
1:00pm – 2:00 pm Introduction to adaptive designs
We shall provide a broad introduction to adaptive designs for clinical trials, why you might consider them, what options are available and some examples of where they have been implemented in real studies. This will include designs for Phase I, Phase II and Phase III clinical trials.
2:00pm – 2:45pm Implementing adaptive designs
In this interactive session, we discuss the practical elements of implementing adaptive designs, members of the Adaptive Designs Working Group will offer their insight into this topic.
2:45pm – 3:00pm Coffee Break
3:00pm – Open discussion session for anyone that has specific trials in mind
This is an opportunity to discuss specific studies that may benefit from an adaptive design. If there are any
adaptive designs implemented (or wanted to implement but decided not to) in the past but had some challenges with (or just want to share your experience with them and get our feedback on this);
adaptive designs that you heard about but would like to learn more and to know how we can help with their implementation;
trials that you are currently planning (or conducting) and that you believe could (potentially) benefit from adaptive designs
Participants are encouraged to submit information on trials they wish to discuss or requests for particular designs in advance of the day to maximise benefit.
Thomas Jaki is Professor of Statistics at Lancaster University and director of the Medical and Pharmaceutical research unit (MPS, www.mps-research.com) which has a long lasting tradition in the design and analysis of clinical trials. He is an NIHR Senior Research Fellow, Coordinator of the EU funded IDEAS network (www.ideas-itn.eu) and a Co-Investigator of the MRC’s North-West Hub for Trials Methodology Research. His methodological research to date has focused on adaptive designs and multiplicity, Bayesian methods and estimation with sparse data. He has worked on estimators for pharmacokinetic parameters, developed adaptive designs – in particular for multi-arm studies – and investigated Bayesian methods for dose-escalation.
Pavel Mozgunov is a Lecturer in Medical Statistics at Lancaster University, UK. He was a Marie-Curie PhD Fellow and completed his PhD at Lancaster University where he was working on novel adaptive designs for complex dose-finding studies. Pavel’s research to date is primarily focused on more efficient designs for Phase I and Phase II clinical trials. Specifically, he is interested in bringing information-theoretic concepts into response-adaptive designs, which can make trial designs more ethical for patients.
Thomas Burnett is a researcher at Lancaster and the outreach officer of the Adaptive Designs Working group. His particular interest is in enrichment designs and designs with multiple treatment arms.