What is this event about?
The conference...
After the success of last year's conference, SAE Media Group is proud to present its 5th annual Adaptive Designs in Clinical Drug Development.
This conference is aimed at exploring the potential of adaptive trials now and in the future through looking at the process, from design through to implementation.
Taking place in central London, UK, you will hear presentations from the key players in the adaptive arena on the big questions adaptive design. Is an adaptive design suitable for my needs? What is the regulatory position on adaptive design? How do I build in adaption to my design? Will a seamless design prove any benefit? What are the logistical and practical implications of running an adaptive trial? Where is the future for adaptive designs?
Attend this event to learn what adaptive designs can add to your clinical drug development experience.
Why not attend the associated workshops as well?
Associated with the conference there will be two half-day workshops taking place on 1st February
- Morning - Design and Analysis of Adaptive Clinical Trials - Hosted by Les Huson, Senior Statistical Consultant in Clinical Trials, Statistical Advisory Service, Imperial College London
- Afternoon - Finding the Right Dose - Are Adaptive Designs Better? - Hosted by Cytel Inc
Led by leaders in their field, these workshops are an excellent opportunity to explore in a more intimate and interactive setting issues which will be discussed at the conference. Subjects covered include statistical and practical issues to be considered when planning an adaptive trial, strategies for successfully analyising the results of an adaptive trial, and a specific look at the use of adaptive designs for dose-finding studies. To see more information about the workshops, please see the adaptive designs workshops page.
Keen to see the detailed programme? Click here.
Want to download the brochure? Click here.
Register for the event here!
Group discounts available - click here
Fancy speaking at the conference? Do you know of anyone who may be interested in speaking? We are always on the look-out for new speakers for our upcoming conferences. Let us know - contact the Conference Producer.
For sponsorship and exhibitioning opportunities, contact our Sponsorship Department.
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Who is chairing this event?
Day One
Jennifer Dudinak
Global Head, Inflammation, Regulatory Affairs
Roche
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Day Two
Marc Vandemeulebroecke
Project Lead and Expert Statistician
Novartis
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Who is speaking at this event?
Our keynote speakers
Alun Bedding
Director, Biostatistics and Programming Development Partners, Drug Development Sciences
GlaxoSmithKline
Pavel Pisa
Translational Medicine Leader
Roche
Marc Vandemeulebroecke
Project Lead and Expert Statistician
Novartis
Jennifer Dudinak
Global Head, Inflammation, Regulatory Affairs
Roche
Chris Jennison
Professor of Statistics
University of Bath
Robert Cuffe
Statistician
GlaxoSmithKline
To see the full agenda for the event, click here.
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Our expert speakers
Melissa Mitchener, Global Study Manager, Roche
David Manner, Group Leader, Endocrine Exploratory and Program Medical Statistics, Eli Lilly
Pierre Gervais, President and Executive Director, Q&T Research
Catarina Mattsson, Project Lead, AstraZeneca
Jack Corman, President, IRB Services
Lisa Hampson, Research Associate, School of Social and Community Medicine, University of Bristol
Paul Jordan, Senior Statistician, Roche
Annette Sauter, Roche
Eric Derobert, Statistician, Sanofi-Aventis
Fanny Windenberger, Statistician, Sanofi-Aventis
James Bolognese, Senior Director for Clinical Trial Services, Cytel Inc
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Conference agenda
Welcome and introductions
Overview of the main types of adaptive clinical trial
Key statistical issues in adaptive trials
Regulatory and logistical considerations
Practical implementation - review of software and methods
Welcome and introductions
Workshop sessions continue
Chairman's opening remarks
Jennifer Dudinak, Global Head, Inflammation, Regulatory Affairs, Roche
Implementing an adaptive design: the investigative site perspective
Pierre Gervais, President and Executive Director, Q&T Research
Patient access with complex design studies and maintaining patient trust
Organisation and structures - study schedule, data entry, queries, volume of supplies
Taking advantage of the challenges
Adaptive design and operational impact
Melissa Mitchener, Global Study Manager, Roche
Need to understand the operational perspective of an adaptive design
Issues with operational aspects of adaptive clinical trials
Case study example
Co-ordination and trial planning: maximising the benefits of an adaptive design through effective management
Catarina Mattsson, Project Lead, AstraZeneca
Critical insight into the breakdown of people involved in an adaptive rather than a traditional trial: preparing for a more flexible operation
Co-ordinating more people under increased time pressure: maximising your efficiency in order to take best advantage of the potential benefits
Ensuring that your study managers are equipped to deal with adaptive trials: establishing the training implications
Adapting communication strategy to ensure that with increased numbers of investigators involved, protocol amendments can be made quickly in order to save time and resources
Jack Corman, President, IRB Services
Adaptive designs pose a difficult problem for ethics review boards
Ethical review during a trial - for each change?
Keeping lines of communication open
Developing internal regulatory guidance for adaptive trials
Jennifer Dudinak, Global Head, Inflammation, Regulatory Affairs, Roche
Current Health Authority guidance
Points to consider: Partnering with internal stakeholders; engaging with Health Authorities
Strategic internal planning
A perspective on the draft FDA adaptive designs guidance
Marc Vandemeulebroecke, Expert Statistician, Novartis
Emerging FDA position on the implementation of adaptive designs in adequate and well-controlled studies
In what situations can adaptive designs be considered; what features make an adaptive design more or less controversial; what requirements are to be fulfilled by an adaptive design
Comments and perspectives from the IBS German and AustroSwiss working group
Statistical inference after an adaptive trial
Chris Jennison, Professor of Statistics, University of Bath
Gaining a better and fuller analysis after an adaptive clinical trial
Confidence intervals
Point estimation
Detecting real treatment effects - an example from oncology
Pavel Pisa, Translational Medicine Leader, Roche
Traditional designs fail where patients can switch between treatments
Conventional intention-to-treat analysis vs. adaptive designs
Avoiding unnecessary termination of investigation of a promising candidate
Chairman’s closing remarks and close of day one
Re-registration and coffee
Chairman's opening remarks
Robert Cuffe, Statistician, Infectious Diseases, Medicine Development Centre, GlaxoSmithKline
New designs – merging phase IIb and III
Robert Cuffe, Statistician, Infectious Diseases, Medicine Development Centre, GlaxoSmithKline
Reducing the time required for clinical studies
When is merging the right choice?
Challenges of getting it right
Majesty and misery of interim dose selection
In inferential phase II/III seamless designs, an interim analysis allows selection of doses to be kept until the end of the trial
By sequentially using the information, this adaptive design is expected to be more efficient than ordinary fixed designs. This design can also be used for a full phase II study devoted to the choice of 1 or 2 doses in a future phase III study
After discretising and constraining the usual case of three doses candidates, the research articulates in two stages:
(1) Identifying the best multiple comparison procedures to be used in fixed design analyses
(2) Combining these chosen procedures for adaptive designs and comparing their performance with that obtained for fixed designs
There is a particular focus on the comparative effect of unbalancing treatment groups in fixed and adaptive designs - the problem of the latency period is also considered
Eric Derobert, Statistician, Sanofi-Aventis
Fanny Windenberger, Statistician, Sanofi-Aventis
Developing a simulation plan and simulation report
David Manner, Group Leader, Exploratory and Programme Medical Statistics, Eli Lilly
When designing a clinical trial, one needs to understand the performance metrics for a given design
This is of particular importance for adaptive trials where one needs to consider many factors and how the results will depend on certain design choices
Simulations are a key tool in evaluating the performance metrics of these choices in adaptive designs
A simulation plan is extremely helpful in deciding on which design factors will vary and which will remain fixed
Additionally one can describe how several competing designs will be assessed and compared with one another
The Simulation Report summarised the performance metrics of the simulations and provides rationale as to why the design was chosen
James Bolognese, Senior Director for Clinical Trial Services, Cytel
Best approaches and recent applications for designing adaptive dose-finding trials
Why it's important to study more than one dose and which specific adaptive approaches are particularly well suited
A comparative look at the most popular design methods for adaptive dose finding - both frequentist and Bayesian - and their relative strengths and weaknesses
Simulation-driven decision-making: comparing different trial design options to arrive at the study best qualified to achieve developmental objectives
Scenarios and the considerations for combining/consolidating traditionally separate studies into a single adaptive study: integrating PoC with dose-finding in a single trial
Group sequential tests for delayed response: a case study
Lisa Hampson, Research Associate in Medical Statistics, University Of Bristol
Current group sequential tests stop with a final decision once a stopping rule is satisfied
However, often the response of clinical interest is to be measured some time after commencement of treatment, meaning there will be subjects at each interim analysis who have been randomised to a treatment but are yet to respond
We derive a new form of group sequential test which gives a proper treatment to these "pipeline" subjects
We use optimal versions of our designs to measure the impact on efficiency of the length of delay in response
We discuss the use of adaptive group sequential procedures for monitoring delayed responses, concentrating on two-stage designs
Case study: combined phase I/PoC study with adaptive dose selection
A combined MAD and POC study
Planned trial
Key design features
Benefits of the design
Paul Jordan, Senior Statistician, Roche
The use of efficient trial design in Phase II to choose the right dose in Phase III
Alun Bedding, Director, Biostatistics and Programming Development Partners, Drug Development Sciences, GlaxoSmithKline
Objective of Phase II is to choose the dose for later confirmatory studies
According to the FDA - 20% of post approval changes were to the dose
Large number of compound failures in Phase III - dose finding is clearly not done in the most efficient manner
Model-based designs, coupled with Bayesian methods and adaptive designs (where appropriate) can improve dose finding by modelling the whole of the dose response curve
The talk will highlight the use of model-based approaches and illustrate using real-life examples
Chairman’s closing remarks
Afternoon tea and close of conference
Workshops
Crowne Plaza - The City
1 February 2011
London, United Kingdom
Crowne Plaza - The City
1 February 2011
London, United Kingdom
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