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What is this event about?

The conference...

After the success of last year's conference, SMi 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.

KOL 1

 Why should you attend this event?

What you will learn about

  • Practical considerations for adaptive trials: running an adaptive trial involves certain practical and logistical challenges above a normal trial design - learn how to build these into your trial plan 
  • Ethical implications: disuss the challenges for Ethics Review Boards when considering an adaptive design - and how to work with the board when submitting an application and during the trial 
  • Regulation and guidance: how to develop internal regulatory guidance for adaptive trials, and an IBS perspective on the FDA draft guidance 
  • Design and analysis: presentations and case studies on how to design a successful trial, and how to carry out during- and post-trial analysis
 Seamless clinical trials
 Seamless trial

How you will benefit

Study how to plan and carry out an adaptive trial

Discover the best strategies to ensure your trial is a success

Identify which design is best for your trial's needs

Network with senior thought leaders working in adaptive designs and trials

Who should attend this event?

Chief Executives, Executive Directors, Vice Presidents, Heads, Directors, Senior Scientists and Team Leaders of

  • Biostatistics
  • Adaptive Trials
  • Trial Design
  • Regulatory Affairs
  • Clinical Drug Development
  • Contract Research
  • Clinical Operations
  • Research and Development
  • Intellectual Property
  • Legislation & Policy Advice
  • Drug and Safety Assessment
  • Clinical Pharmacology
  • Experimental Medicine

Delegates at our previous Adaptive Designs conferences came from across the world

Graph of delegates by region

Conference programme

8:30 Registration and coffee

9:00 Chairman's opening remarks

Jennifer Dudinak

Jennifer Dudinak, Global Head, Inflammation, Regulatory Affairs, Roche

9:10 Implementing an adaptive design: the investigative site perspective

Pierre Gervais

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
  • 9:50 Adaptive design and operational impact

    Melissa Mitchener

    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
  • 10:30 Morning coffee

    11:00 Co-ordination and trial planning: maximising the benefits of an adaptive design through effective management

    Catarina Mattsson

    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
  • 11:40 The question of ethics

    Jack Corman

    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
  • 12:20 Networking lunch

    13:50 Developing internal regulatory guidance for adaptive trials

    Jennifer Dudinak

    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
  • 14:30 A perspective on the draft FDA adaptive designs guidance

    Marc Vandemeulebroecke

    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
  • 15:10 Afternoon tea

    15:40 Statistical inference after an adaptive trial

    Chris Jennison

    Chris Jennison, Professor of Statistics, University of Bath

  • Gaining a better and fuller analysis after an adaptive clinical trial
  • Confidence intervals
  • Point estimation
  • 16:20 Detecting real treatment effects - an example from oncology

    Pavel Pisa

    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
  • 17:00 Chairman’s closing remarks and close of day one

    8:30 Re-registration and coffee

    9:00 Chairman's opening remarks

    Robert Cuffe

    Robert Cuffe, Statistician, Infectious Diseases, Medicine Development Centre, GlaxoSmithKline

    9:10 New designs – merging phase IIb and III

    Robert Cuffe

    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
  • 9:50 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

    Eric Derobert, Statistician, Sanofi-Aventis

    Fanny Windenberger

    Fanny Windenberger, Statistician, Sanofi-Aventis

    10:30 Morning coffee

    11:00 Developing a simulation plan and simulation report

    David Manner

    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
  • 11:40 Get the dose right

    James Bolognese

    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
  • 12:20 Networking lunch

    13:50 Group sequential tests for delayed response: a case study

    Lisa Hampson

    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
  • 14:30 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

    Paul Jordan, Senior Statistician, Roche

    Annette Sauter

    Annette Sauter, , Roche

    15:10 The use of efficient trial design in Phase II to choose the right dose in Phase III

    Alun Bedding

    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
  • 15:50 Chairman’s closing remarks

    16:00 Afternoon tea and close of conference

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    Workshops

    Design and Analysis of Adaptive Clinical Trials
    Workshop

    Design and Analysis of Adaptive Clinical Trials

    Crowne Plaza - The City
    1st February 2011
    London, United Kingdom

    Finding the Right Dose – Are Adaptive Designs Better?
    Workshop

    Finding the Right Dose – Are Adaptive Designs Better?

    Crowne Plaza - The City
    1st February 2011
    London, United Kingdom

    Crowne Plaza - The City

    19 New Bridge Road
    London EC4V 6DB
    United Kingdom

    Crowne Plaza - The City

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

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    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

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    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

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