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 Adaptive Design

After the success of last year's conference, SMi is proud to present their 4th 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.  The process will be emphasised and explained at all times by reference to real case studies.

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?  How do you manage the additional challenges of data collection, storage and manipulation?  Where is the future for adaptive designs?

Attend this event to learn what adaptive designs can add to your clinical drug development experience.

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: smiproduction@smi-online.co.uk.

For sponsorship and exhibitioning opportunities, contact sponsorshipdept@smi-online.co.uk

 Adaptive Design

 

 

Attend and be updated on:

Regulation - how the new FDA guidelines are shaping the adaptive market and how they fit in with EMEA and Japanese regulations

Trial Design - designing a successful adaptive trial

Implementing Adaptive Designs - through case studies you will get practical advice on how to overcome the challenges presented by adaptive trials

Maintaining Data Integrity - how to keep control of your data

The Future - where the industry goes from here

 Pills
 Test

Key benefits of attending:

Listen to some of the most important and influential experts currently working in adaptive designs

Study the current issues surrounding designing and carrying out adaptive trials

Learn about the future potential for the pharmaceutical industry

Network with people you want to meet from the adaptive design arena


Feedback from SMi's Adaptive Designs 2009:

"Very good speakers; intelligent, timely topics - it gave me a lot to think about" - Senior Representative, Eli Lilly

""Better than other conferences, more focused" - Senior Representative, Genentech

"Compared to other conferences, SMi was great.  The organisation, conference matierials, quality of presentations and venue were all excellent" - Senior Representative, Biogen Idec 

Chief Executives, Vice Presidents, Heads, Directors, Scientists and Project Leaders of:
  • Clinical Drug Development
  • Trial Design
  • Biostatistics
  • Regulatory Affairs
  • Contract Research Organisations
  • Clinical Operations
  • Pharmacokinetics
  • Pharmacodynamics
  • Research and Development
  • Intellectual Property
  • Legislation & Policy Advice
  • Drug and Safety Assessment
  • Clinical Pharmacology
  • Experimental Medicine

Our 2008 and 2009 attendees came from:

Where the previous delegates came from

 


 Who is attending this year?

Our speakers come from a wide range of international companies and organisations across the pharmaceutical sector - in addition, we already have senior representatives from the following organisations registered to attend:

  • Schering-Plough
  • MedImmune
  • Sanofi-Aventis
  • Cephalon
  • University of Florida
  • Université Paris-Sud 11
  • FOCUS Clinical Drug Development
  • Simulations Plus Inc
  • B&C Group

2009 Delegates worked for:

Johnson & Johnson  GlaxoSmithkline  Sanofi-Aventis  AstraZeneca  Merck Serono  Eli Lilly  Biogen Idec  Biovitrium AB  Shire PLC  BTG  Thomson Reuters  University of Cologne  Syntaxin  Hum-Molgen  Genentech

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Robert Clay

Robert Clay, Vice President Regulatory Affairs, Oncology and Infection, AstraZeneca

9:05 ADAPTIVE DESIGN REGULATION IN THE EU AND JAPAN

Robert Clay

Robert Clay, Vice President Regulatory Affairs, Oncology and Infection, AstraZeneca

  • Adaptive trials in the EU
  • Adaptive trials in Japan
  • Creating a global outlook with a high level of standardisation
  • 9:40 LARGE RANDOMISED PIVOTAL TRIAL IN CANCER

    Lothar Tremmel

    Lothar Tremmel, Senior Director and Group Leader, Biostatistics, Cephalon

  • An adaptive group sequential design used in a large, randomised trial used for a successful NDA in cancer
  • Regulatory interactions, concerns and how they were addressed
  • How the adaptive group sequential design fares as compared to traditional group sequential design
  • 10:15 LATE STAGE AND SEAMLESS ADAPTIVE TRIAL CASE STUDIES

    Yannis Jemiai

    Yannis Jemiai, Associate Director of Biostatistics, Cytel

  • Phase III oncology trial - applying adaptive sample size re-assessment in a survival set-up
  • Phase III cardiovascular trial - the critical advantage of adaptive population enrichment
  • Phase II/III seamless adaptive trial - understanding methodology, rules, regulatory view and logistics
  • 10:50 Morning Coffee

    11:20 ADAPTIVE TRIALS AND TRADITIONAL DESIGNS

    Christopher Jennison

    Christopher Jennison, Professor of Statistics and Dean of the Faculty of Science, University of Bath

  • Choosing between fixed sample, group sequential and adaptive designs
  • Waiting to specify the power curve: an adaptation too far
  • Seamless Phase II/Phase III: simplicity vs. efficiency
  • Multiple treatments, multiple populations: when only "adaptation" works
  • The bigger picture: looking beyond a single stage of the drug development process
  • 11:55 OPTIMAL GROUP SEQUENTIAL DESIGNS

    Fredrik Ohrn

    Fredrik Ohrn, Senior Statistician, AstraZeneca

  • Briefly show how designs with optimal efficiency can be derived
  • Make efficiency comparisons with an existing method from the literature
  • Compare adaptive and non-adaptive designs
  • Give examples of easily implementable error spending versions of non-adaptive designs
  • 12:30 DOSE SELECTION IN EARLY PHASE CLINICAL TRIALS

    Barbara Bogacka

    Barbara Bogacka, Reader in Probability and Statistics, Queen Mary, University of London

  • Different adaptive designs including PK/PD data
  • Using PK/PD data effectively when considering dose selection
  • Optimising selection with respect to the chosen criterion for the trial
  • 13:05 Networking Lunch

    14:05 REAL-TIME COLLECTION IN ADAPTIVE TRIALS TODAY

  • Examining real-time data capture in adaptive trials: overcoming the challenges and creating the most efficient strategy possible
  • Real time simulations, analysis and decision-making: establishing new solutions
  • The effective, immediate implementation of these solutions
  • Alan Eggleston

    Alan Eggleston, Global Head of Sales and Marketing, Cmed Group Ltd

    Martin Kimber

    Martin Kimber, Clinical Trials Consultant, Tessella Support Services Plc

    14:40 ADAPTIVE TRIAL DESIGNS FOR ONCOLOGY TRIALS

    Tom Parke

    Tom Parke, Head of Clinical Technologies, Tessella Support Services Plc

  • Benefits for oncology of adaptive trials
  • Difficulties presented by progression free survival endpoint
  • Several real examples
  • 15:15 Afternoon Tea

    15:45 SPECIAL ADDRESS: THE ROLE OF SIMULATION

    Graeme Archer

    Graeme Archer, Senior Director, Neurosciences Discovery Biometrics, GlaxoSmithKline

  • Adaptive designs can be highly efficient mechanisms to investigate NCEs in early POC studies
  • They also lend themselves to a more relevant form of statistical interference: Bayesian reasoning
  • Simulation methods can be used to understand the operating characteristics of any design
  • This talk will demonstrate how such methods have been used in a variety of neuroscience POC studies in GSK
  • 16:20 A SHORTCUT TO PERSONALISED MEDICINE?

    Yu Shyr

    Yu Shyr, Professor & Chief, Division of Cancer Biostatistics, Vanderbilt University

  • Biomarkers vs. surrogate endpoints
  • Prognostic biomarker vs. perdictive biomarker
  • Biomarker-adaptive threshold design
  • Adaptive signature design
  • High-dimensional biomarker trail design
  • 16:55 THE CASINO APPROACH TO MULTIPLICITY

    Carl-Fredrik Burman

    Carl-Fredrik Burman, Statistical Science Director, AstraZeneca

  • Do you want to draw several confirmatory conclusions from you trial?
  • Then FDA requires tight control of the overall (type I) error rate alpha
  • Learn how to safeguard alpha with a brand new method
  • Draw simple graphs and forget about the maths!
  • See the implications on adaptive designs with dose selection
  • Apply your knowledge in our Virtual Casino and win amazing prizes...
  • 17:30 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Alun Bedding

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

    9:10 KEYNOTE PRESENTATION: A BAYESIAN ADAPTIVE RANDOMISATION DESIGN IN RESPIRATORY MEDICINE

    Alun Bedding

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

  • Setting the scene for using adaptive randomisation
  • Details of the endpoints and modelling
  • Simulation of the design and impact on the size and duration of the study
  • Some logistic hurdles

     

  • 9:50 TREATMENT SELECTION BY DESIGN

    Sue Todd

    Sue Todd, Reader in Medical Statistics, University of Reading

  • An adaptive design for treatment selection and evaluation
  • Exploration in the context of a study in Multiple Sclerosis
  • Simulation study of the properties of alternative designs
  • 10:30 BAYESIAN ADAPTIVE RANDOMISATION FOR A PHASE II ONCOLOGY TRIAL

    Pantelis Vlachos

    Pantelis Vlachos, Principal Biostatistician, Merck Serono

  • Classical vs adaptive randomisation 
  • Simulation of course of trial
  • Evaluation of trial operating characteristics
  • Logistic and practical issues
  • 11:10 Morning Coffee

    11:40 A RECENT CASE STUDY OF OPERATIONAL SEAMLESS PHASE II/III DESIGN

    Loïc Darchy

    Loïc Darchy, Senior Statistician, Sanofi-Aventis R&D

  • Trial design - main challenges
  • Feedback from health authorities
  • Overall Type I error control
  • Comparison to another design
  • Discussion - lessons learnt
  • 12:20 A BAYESIAN ADAPTIVE RANDOMISATION IIA/IIB STUDY

    Yili Pritchett

    Yili Pritchett, Research Fellow, Director Clinical Statistics, Abbott Laboratories

  • Going through the mathematical components of the design
  • Illustration of the dynamic updates as real data accumulate
  • Calculation of the savings made using the adaptive design
  • 13:00 Networking Lunch

    14:00 SEAMLESS PHASE II/III ADAPTIVE DESIGN WITH DOSE SELECTION

    Caroline Morgan

    Caroline Morgan, Director of Clinical Operations, Cardinal Systems (CRO)

  • Superiority and non-inferiority comparisons
  • Pre-study simulations
  • Parallel scientific advice (FDA & EMEA) and PDCO
  • Optimising the clinical trial workflow
  • 14:40 IMPLEMENTING ADAPTIVE DESIGN: A TECHNOLOGY PERSPECTIVE

    Scott Hamilton

    Scott Hamilton, Senior Director, Biometrics and Randomisation Technologies, United BioSource Corporation

  • Clinical technologies and clinical trials
  • Adaptive design implementation challenges
  • Strategies for a successful implementation
  • 15:20 Afternoon Tea

    15:50 PHASE II/III ADPTIVE DESIGN WITH TREATMENT SELECTION

    David Lawrence

    David Lawrence, Senior Statistician, Novartis

  • Trial design of a confirmatory study with pre-planned adaption at interim
  • Interim decision making
  • The role of the sponsor
  • Recommendations for ASDs in this setting
  • 16:30 THE CLASSIC BAUER-KOHNE ADAPTIVE DESIGN

    Vera Lisovskaja

    Vera Lisovskaja, Researcher, Biostatistics, AstraZeneca

  • A very popular type of adaptive design could lead to illogical conclusions
  • A drug can be "proved" to be efficacious, although the average effect is no better than a placebo
  • Learn a simple way to protect your analysis from such anomolies
  • Choose sample size re-estimations, for which the improved test is as powerful as the original
  • 17:10 Chairman’s Closing Remarks and Close of Day Two

    +

    Workshops

    Adaptive Designs for Multi-Armed Trials
    Workshop

    Adaptive Designs for Multi-Armed Trials

    Crowne Plaza Hotel - St James
    2nd February 2010
    London, United Kingdom

    Planning for Success: Adapt by Design
    Workshop

    Planning for Success: Adapt by Design

    Crowne Plaza Hotel - St James
    2nd February 2010
    London, United Kingdom

    A Practical Lesson in Adaptive Trial Design
    Workshop

    A Practical Lesson in Adaptive Trial Design

    Crowne Plaza Hotel - St James
    5th February 2010
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    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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