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Following the success of last year's conference, The SMi Group are pleased to announce the arrival of Adaptive Designs 2007.

This event will bring together industry leaders, to discuss current innovations in adaptive trial design.

Special interactive group session: Take advantage of the opportunity to design your own adaptive trial set to a research question!

A must attend event for those involved in clinical trials design and drug development

  • Dr Michael Krams, aVP, Adaptive Trials, Clinical Development, Wyeth
  • Dr Vlad Dragalin, Senior Director, Research Statistics, GlaxoSmithKline
  • Dr Jerald Schindler, President, Cytel Pharmaceutical Research
  • Dr Carl-Fredrik Burman, Statistical Science Director, AstraZeneca
  • Dr Christian Sonesson, Senior Statistician, AstraZeneca
  • Dr William Wang, Associate Director, Clinical Biostatistics, Merck & Co
  • Robert Hemmings, Statistics Unit Team Leader, Medicines & Healthcare products Regulatory Agency (MHRA)
  • Dr Mark Chang, Technical Director, Millennium Pharmaceuticals
  • Dr Jerry Weaver, Associate Director, Pfizer
  • Dr Steve Pascoe, Global Head, Respiratory/Dermatology Profiling Exploratory Clinical Development, Novartis


Key issues to be addressed at the conference include:

  • ADAPTIVE TRIAL DESIGN INFRASTRUCTURE: Hear from prominent thought leaders as they discuss the challenges encountered whilst acquiring early data and linking information with drug supply
  • IMPLEMENTING ADAPTIVE TRIALS: Listen as our experts discuss whether the market is ready to embrace adaptive clinical trials and how to deal with any complications in design and implementation that may arise
  • REGULATORY ACCEPTANCE: Discover the opportunities and challenges arising from EMEA, FDA and MHRA guidelines. What effect will they have on your businesses?
  • BAYESIAN METHODS: Overcome the challenges associated with Bayesian tools whilst providing a practical point of view to efficiently and effectively decrease the time spent conducting clinical trials
  • MODELLING AND SIMULATION: Hear practical examples and case studies on the application of adaptive design in various stages of development and methods to minimise risk in the drug development process
  • EXCLUSIVE INFORMAL NETWORKING: Collaborate with industry peers in an environment promoting information exchange

Conference programme

8:30 Registration & Coffee

9:00 Joint Chairpersons' Opening Remarks

Jerald Schindler

Jerald Schindler, President, Cytel Pharmaceutical Research

Alun Bedding

Alun Bedding, Director, Biostatistics and Programming Development Partners, Drug Development Sciences, GlaxoSmithKline

9:10 ADAPTIVE DESIGNS – TAXONOMY AND CLASSIFICATION

Inna  Perevozskaya

Inna Perevozskaya, Clinical Biostatistics, Merck Research Laboratories

  • Providing a common denominator for terminology
  • Defining what is in and out of scope
  • Proposing where to focus our efforts
  • Giving some key examples, case studies and/or simulations
  • 9:50 ISSUES IN IMPLEMENTING ADAPTIVE TRIALS

    Steve Pascoe

    Steve Pascoe, Global Head Respiratory/ Dermatology Profiling Exploratory Clinical Development, Novartis

  • Ethical issues
  • Complications in design and implementation
  • Increasing awareness of adaptive designs
  • Reducing biases
  • Behavioural problems
  • Is the market ready to fully embrace adaptive clinical trials?
  • 10:30 Morning Coffee

    11:00 ADAPTIVE DESIGNS - A REGULATORY PERSPECTIVE

    Robert  Hemmings

    Robert Hemmings, Statistics Unit Team Leader, MHRA

  • CHMP reflection paper on flexible designs
  • Opportunities and challenges from a regulatory perspective
  • Optimising regulatory interactions
  • 11:40 ADAPTIVE TRIAL DESIGN INFRASTRUCTURE

    Jerald Schindler

    Jerald Schindler, President, Cytel Pharmaceutical Research

  • Key issues in operation for effective clinical trials
  • Optimisation of clinical trial infrastructure
  • Infrastructure needed to incorporate flexibility into trial design
  • Providing rapid access to ongoing trial information
  • Building the infrastructure
  • Design, process and planning
  • 12:20 Networking Lunch

    13:50 MODEL-BASED ADAPTIVE DESIGNS

  • Proposing a general class of adaptive designs based on optimal experimental design methodology
  • Estimation of the target dose as accurately as possible
  • Ethical concerns - ensuring the treatment of patients in the study are at doses that are both safe and efficacious
  • Alun Bedding

    Alun Bedding, Director, Biostatistics and Programming Development Partners, Drug Development Sciences, GlaxoSmithKline

    14:30 IMPLEMENTATION – GETTING IT RIGHT BEFORE PHASE III

    Tom Parke

    Tom Parke, Associate Director, Software Development, Tessella Support Services Plc

  • Simulation guided trial design:
    - What’s the question?
    - Optimising the design
  • Running dose adaptive studies
  • 15:10 Afternoon Tea

    15:40 SAMPLE SIZE REASSESSMENT - GOOD OR BAD?

  • Many recent papers promote flexible designs that allow substantial design modifications
  • The type I error can be protected by using a weighted test
  • However, the efficiency of these designs has been questioned
  • We also show that the weighted test can lead to absurd conclusions
  • What can be done to combine flexibility with a convincing inference?
  • Dr Christian Sonnesson

    Dr Christian Sonnesson, Senior Statistician, AstraZeneca

    Carl-Fredrik Burman

    Carl-Fredrik Burman, Senior Statistical Scientist, AstraZeneca

    16:20 INTERACTIVE ROUNDTABLES

    17:00 Joint Chairpersons' Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Joint Chairpersons' Opening Remarks

    Jerald Schindler

    Jerald Schindler, President, Cytel Pharmaceutical Research

    9:10 ADAPTIVE DESIGNS

    Franz Koenig

    Franz Koenig, University Assistant, Medical University of Vienna

  • Treatment (dose) selection
  • Adaptive designs and the closed test principle
  • Sample size reassessment
  • Seamless phase II/II designs
  • 9:50 SEAMLESS PHASE II/III – A CASE STUDY

  • What is the scope? example: pruning doses
  • Statistical methodology – controlling type I error
  • Implementation – data monitoring committee: sponsor involvement?
  • Regulatory perspective
  • Are we ready for prime time?
  • Alun Bedding

    Alun Bedding, Director, Biostatistics and Programming Development Partners, Drug Development Sciences, GlaxoSmithKline

    10:30 Morning Coffee

    11:00 APPLICATION OF GROUP SEQUENTIAL ADAPTATION IN VACCINE DEVELOPMENT

  • Sample size re-estimation
  • Group sequential design
  • Group sequential adjusted estimation
  • Software implementation
  • William Wang

    William Wang, Associate Director, Clinical Biostatistics, Merck & Co

    Ivan Chan

    Ivan Chan, Director, Clinical Biostatistics, Merck & Co

    11:40 ADAPTIVE APPROACHES TO LEARNING ABOUT SAFETY

    Jerry Weaver

    Jerry Weaver, Associate Director, Pfizer

  • Designs and statistical methods to assist in making decisions
  • Streamlining the drug development process
  • Reducing the risk of late stage clinical failure
  • Lowering development costs
  • 12:20 Networking Lunch

    13:50 COMPARISONS OF FREQUENTIST AND BAYESIAN ADAPTIVE APPROACHES

    Mark Chang

    Mark Chang, Associate Director, Millennium Pharmaceuticals

  • Evidence measuring
  • Utilisation of information resources
  • Design, monitoring, and analysis of adaptive trials
  • Classic and Bayesian decision theories - optimisation
  • Transition from hybrid to Bayesian approaches
  • Regulatory aspects
  • 14:30 SPEEDING UP THE PROCESS OF CLINICAL TRIALS

    Junfang Li

    Junfang Li, Director,

  • Opportunities and challenges
  • Development in Bayesian methods
  • Application of Bayesian methods in a novel product
  • Practical examples
  • The challenges of the Bayesian approach in the regulatory setting
  • 15:10 Afternoon Tea

    15:40 BAYESIAN METHODS WITH A FOCUS ON ONCOLOGY

    Beat Neuenschwander

    Beat Neuenschwander, Senior Expert Statistical Methodologist, Novartis Pharma AG

  • Key points for the Bayesian approach to clinical trials
  • Use of Bayesian methods in support of decision-making in clincal development
  • Providing a practical point of view
  • Producing a checklist of essential items needed
  • 16:20 A BAYESIAN APPROACH TO MULTIVARIATE REFERENCE REGIONS

  • Methods for multivariate reference regions
  • Current measure of cardiovascular risk in thorough QT studies
  • Moving beyond QT prolongation using beat-to-beat QT-TQ data
  • QT-TQ reference region for a normal individual
  • Kimberly Crimin

    Kimberly Crimin, Senior Principal Biostatistician II, Wyeth

    Robb Muirhead

    Robb Muirhead, Senior Director, Pfizer

    17:00 Chairman’s Closing Remarks and Close of Conference

    +

    Workshops

    Introduction to Adaptive Designs - Concepts & Issues
    Workshop

    Introduction to Adaptive Designs - Concepts & Issues

    Crowne Plaza Hotel - The City
    7th February 2007
    London, United Kingdom

    Crowne Plaza Hotel - The City

    19 New Bridge Street
    London EC4V 6DB
    United Kingdom

    Crowne Plaza Hotel - 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.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    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.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    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.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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