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Silver Sponsor:      Sponsor:            Organised by:


3rd Annual

Adaptive Trials 2009
Tuesday 8 and Wednesday 9 December 2009, Brussels, Belgium

Maximising the potential of your adaptive clinical trials

  KEYNOTE SPEAKERS:
  Sue-Jane Wang,                 Professor Andy Grieve,
  Assoc. Dir., ADAPTIVE          Department of Public
  DESIGN, FDA                    Health Sciences, KING’S
                                 COLLEGE LONDON
  Michel Krams, Assistant
  Vice President, Adaptive       Christian Sonasson,
  Clinical Trials, Clinical      Information Science Office,              This e
  Development WYETH                                                              vent i
  (provisional)
                                 ASTRAZENECA
                                                                          co-loc       s
                                                                                 ate
                                                                           with t d
                                 Catarina Mattsson,
  Bryan McDowell, Clinical       Clinical Project Manager,

                                                                       Explo he
  Trial Head, Dermatology,       ASTRAZENECA
  NOVARTIS
                                                                              ra
                                 Pavel Pisa, Translational
                                                                      Clinic tory
  Thomas Sudhop, Director        Medicine Leader, ROCHE
                                                                            al Tria
  and Professor, Head of
  the Division for Scientific    Philip De Ridder, Director,
                                                                                   ls
  Services, BFARM                JOHNSON AND JOHNSON

  Dr Solange Rohou, Director     Hans Ulrich Burger,
  European Regulatory            Biostatistics, Section
  Affairs, ASTRAZENECA           Leader, ROCHE

  Alun Bedding, Director,                                      THREE HIGHLIGHTS OF THE CONFERENCE
  GSK
                                                               • Learn how new and existing
                                                                 regulations are shaping the
                                                                 future of adaptive trials
                                                               • Analysis of seamless phase II/III
                                                                 adaptive trials and how their design
 TOP COMPANIES REPRESENTED                                       and logistics can maximise the
                                                                 efficiency of your clinical trials
 •   GlaxoSmithKline            • Schering-Plough
 •   Roche                      • Vifor Pharma                 • A selection of roundtable
 •   Novartis                   • Johnson and                    discussions to enable you to
 •   AstraZeneca                  Johnson                        exchange ideas and experiences on
 •   Merck & Co                                                  all aspects of adaptive design


Register now:
Online: www.adaptivetrials-events.com/2009                      Email: book@arena-international.com
Tel: +44 (0)207 7753 4268                                       Fax: +44 (0)20 7915 9773
Programme Day one                                                                   Tuesday 8 December 2009

08.30 Registration                                                                           in order maximise the likelihood of regulatory acceptance for seamless trials
                                                                                       ●     Highlighting the differences between regulatory bodies to ensure that
09.00 Opening remarks from the Chair                                                         global adaptive designs are compliant internationally
                                                                                       ●     Phase III: identifying safety concerns and data validity in late
keynote openinG aDDress:                                                                     phase trials
                                                                                       ●     Case studies to illustrate when an adaptive Phase III design is likely to
09.10 An industry update: defining the role of adaptive trials                               be acceptable
      in a difficult economic environment and identifying                                      Thomas Sudhop, Director and Professor, Head of the Division for
      opportunities to use more efficient trial designs                                        Scientific Services, BFARM
   ●   Running an adaptive trial in an environment of restricted resources:                  Prof Bruno Flamion, FEDERAL AGENCY FOR MEDICINES AND HEALTH
       ascertaining how the recession is affecting the trials                                PRODUCTS, BELGIUM
   ●   Analysing progression in adaptive trials: how is the format developing                Ingvild Aaløkken, Head of Section, NMA
       and what trends are being observed and what does it mean for your
       strategy?                                                                    12.10 Case Study: Dissecting successful and unsuccessful
   ●   An appraisal of this year’s trials: tracking the successes in order to             submissions to identify business critical factors that
       identify opportunities                                                             enable you to succeed first time
   ●   Forecasting how the adaptive market will progress in order to ascertain         ●     Analysing some unsuccessful attempts: identifying why the trials were
       areas of growth                                                                       not approved and the lessons that were learned
   ●   Key questions to be answered regarding adaptive trials and their                ●     Achieving regulatory acceptance: identifying the characteristics of an
       usefulness: identifying the lessons that need to be learned                           acceptable design
       Provisional Speaker: Michael Krams, Assistant Vice President, Adaptive          ●     The research process: ascertaining whether or not the trial is well suited
       Clinical Trials, Clinical Development, WYETH                                          to an adaptive approach
                                                                                       ●     The design: how we went about fulfilling regulatory requirements
DeDucinG what the reGulators want:                                                     ●     Answering key questions from the agency: identifying areas of
learninG their reQuireMent                                                                   regulatory concern and redesigning the trial to take these into account
                                                                                       ●     Ensuring that interim analyses and final evaluation results in viable data
09.40 An update from the FDA: evaluating their position                                      that meets the regulator’s approval
       Sue-Jane Wang, Assoc. Dir., ADAPTIVE DESIGN, FDA                                      Dr Solange Rohou, Director European Regulatory Affairs, ASTRAZENECA
       Sue-Jane Wang will provide new insight into the FDA perspective
       of adaptive clinical trials and the scientific principles involved. The      12.40 Optimising your approach towards Real Time Data
       excusive content will help you to better understand the FDA attitude
                                                                                          Collection, Management and Reporting in order to
       towards adaptive design and how they see the use of such trials
       developing in the future.                                                          streamline the data analysis process:
                                                                                       ●     How to use an eProtocol tool to create an effective protocol design
10.10 Adaptive clinical designs: understanding the evolving                            ●     Developing In-stream DB development using CDISC/ODM XML
                                                                                             Examining real-time data capture in adaptive trials: overcoming the
      interface between developers and the FDA and other                               ●
                                                                                             challenges and creating the most effective possible stategy
      regulators                                                                       ●     Real-time simulations, analysis and decision making: establishing new
   ●   Going for an adaptive clinical study design: a “strategic game” with a                solutions
       corporate and a regulatory player                                                     Richard Young, Director, Business Development, Cmed
   ●   Regulators on a learning curve: is it a deterrent for developers and how
       can the situation be improved?                                               13.10 Lunch
   ●   Trading inherent uncertainty for added insight: a challenging approach
       for both sides but how can the risks be reduced?                               Stream A: Clinical                        Stream B: Statistics
   ●   Trial simulations: developing joint roadmaps for handling clinical             Establishing the                          Streamlining the design
       decision scenarios                                                             logistical implications                   process: setting the
   ●   Analysing pre-scheduling collaborative reviews, discussion and
       reconsideration in adaptive designs
                                                                                      of running a successful                   groundwork for running a
   ●   Establishing U.S. developments: evolution of the FDA position since the        adaptive trial                            seamless adaptive trial
       May 2006 Medical Device draft
   ●   Understanding European regulatory frameworks: evolution of the EMEA            14.30 Case Study:                          14.30 Designing an
       position since the March 2006 “Reflection Paper”                                Enabling an effective drug                  adaptive clinical trial:
   ●   Developments at the ICH: towards a globalized position on adaptive designs     supply and distribution                    analysing the costs and
       Hermann A. M. Mucke, H.M. PHARMA CONSULTANCY                                   system: avoiding costly                    benefits from a statistics
10.40 The European regulator’s perspective on adaptive                                mistakes                                   point of view
                                                                                      ●    Ensuring that the supply              ●   Uncovering the latest
      designs: Ensuring that your trial is accepted                                        department is sufficiently                developments in statistics in
   ●   What are the NMA and EMEA looking for in adaptive trial submissions?                capable of dealing with the               adaptive trials and the lessons
       Developing a more thorough understanding of the key factors                         increased complexity of the               that have been learned as the
   ●   How can you make sure your submissions are successful? Establishing                 supply requirements for an                number of completed trials
       the critical characteristics of a successful submission                             adaptive algorithm                        increase
   ●   Examining European case studies to identify which have been                    ●    Just in time delivery:                ●    Key considerations when
       successful and the characteristics which set them apart                             coordinating your approach                designing an adaptive trial:
   ●   Analysing areas of regulatory concern in late phase trials and identifying          and avoiding overage and the              preparing you for a new
       possible solutions                                                                  accompanying financial and                approach
   ●   Forecasting the future for adaptive trials from a regulatory perspective            logistical consequences               ●   Identifying the types of
       Ingvild Aaløkken, Head of Section, NMA                                         ●    If a dose arm is created or the           adaptive trial and how to
11.10 Morning refreshments                                                                 sample size changed, how can              determine which variant is
                                                                                           outage be effectively avoided?            most suitable
11.40 Regulatory Panel discussion: An exclusive opportunity                           ●    Setting up your IVRS systems to       ●   Determining the most cost
      to discover first hand what the regulators are looking                               cope with increased complexity:           and time effective solution for
      for and what the future might hold with a view to                                    the basis for an effective supply         your drug
      clarifying your own approach                                                         chain                                       ●   Spotlight on resources:
   ●   Analysing key requirements in early phase adaptive trials: a guide to                  ●   Forecasting potential                    planning for the time
       reducing the regulatory risk of embarking on an adaptive design                            changes to dosage                        and people involved in
   ●   Evaluating areas of concern and pinpointing the key considerations
Programme Day one                                                                   Tuesday 8 December 2009


       levels and the patient profile: factoring in complexity in order to more             designing an adaptive trial as opposed to a more traditional
       accurately control costs and reduce error                                            format
       Michael Richter, Global Clinical Supply Coordinator, F. Hoffmann                 ●   Use of Bayesian techniques in adaptive trials
       LA-ROCHE                                                                             Alun Bedding, Director, GSK

15.00 The implementation of a seamless trial from inception                          15.00 Establishing the roles of short term endpoints in
      to final report: running an effective trial                                           clinical trials in order to plan more effectively
   ●   Assessing what is required of your database: ensuring that you are               ●   Analysing the criteria for the use of a surrogate endpoint
       equipped to deal with the increased heterogeneity and quantity of data           ●    Short term endpoints in Phase II proof of concept studies
       and are able to access it quickly in order to record, and respond to,            ●   Incorporating short term endpoints in Phase II adaptive dose
       interim analysis                                                                     finding
   ●   Developing an effective strategy when planning your trial: avoiding              ●   Using a short term endpoint in a Phase III study with delayed
       costly mistakes                                                                      response
   ●   Understanding how electronic technology can shape adaptive clinical              ●   Short and long term endpoints in a seamless Phase II/III trial
       trials                                                                               Professor Christopher Jennison, Statistics, Bath University
   ●   Identifying common pitfalls and how they can best be avoided
   ●   Understanding the logistics of the final report, how it differs from that     15.30 Data analysis and trial adaptation for dose-finding
       of a traditional trial and how to produce the best possible reports                 studies: making the right choices in order to
       Bryan McDowell Clinical Trial Head, Dermatology, NOVARTIS                           maximise efficiency
                                                                                        ●   Determining the appropriate type of adaptation: correctly
15.30 Coordination and trial planning: maximising the                                       identifying which change should be made
      benefits of an adaptive design through effective                                   ●   Choosing the statistical analysis method taking the adaptive
      management                                                                            nature of the trial into account
   ●   Critical insight into the breakdown of people involved in an adaptive            ●   Analysing which outcomes can be used to identify a necessary
       rather than a traditional trial: preparing for a more flexible operation              adaptation: early outcomes, primary endpoints and safety
   ●   Coordinating more people under increased time pressure: maximising                   results
       your efficiency in order to take best advantage of the potential benefits        ●   What are the implications for the logistics of the trial?
   ●   Ensuring that your study managers are equipped to deal with adaptive             ●   Clarifying how to implement early stopping possibilities of an
       trials: establishing the training implications                                       adaptive trial in order to save money without compromising the
   ●   Adapting communication strategy to ensure that with increased                        trial’s integrity
       numbers of investigators involved, protocol amendments can be made                   Frank Miller, Principal Scientist, Statistics & Informatics,
       quickly in order to save time and resources                                          AstraZeneca R&D
       Catarina Mattsson, Clinical Project Manager, ASTRAZENECA                      16.00 Afternoon refreshments
16.00 Afternoon refreshments                                                         16.30 Case study: Phase II adaptive design: worked
16.30 Effectively managing patients during a complex                                        example using prior data and optimal design
      adaptive trial                                                                       theory
   ●   Maximising the potential for increased efficiency in recruitment:                ●    Understanding the main aims of Phase II including
       minimising the necessary patient numbers and devising an effective                    characterising dose-response and appropriate dose-selection
       system for maintaining the optimum number of patients as the needs               ●    Adaptive designs based on dose re-selection after collecting
       of the trial change                                                                   some initial data appear attractive: analysing the potential
   ●   Creating and maintaining a fast and efficient communication strategy                  benefits
       capable of ensuring that your investigators and patients are fully aware         ●    Revealing more about an adaptive design that addresses the
       of what the trial requires of them                                                    following issues:
   ●   Ensuring that data collected during interim analysis does not                        ● Initial dose-selection
       compromise the trial’s blindness in order to meet the requirements of                ● Parametric model fitting to this initial data supported with
       the regulator                                                                             prior
   ●   Randomisation challenges: as dosage arms change how can                              ● data from a drug with the same MOA
       randomisation be effectively achieved?                                               ● Final stage doses selected using optimal design theory
   ●   The implications for patient information: ensuring that your patient is               Dr Patrick Johnson, Statistician, VIFOR PHARMA
       aware of the logistical implications of participation in an adaptive trial
       in order to reduce patient drop out and maintain the integrity of the         17.00 Maximizing the usefulness of adaptive trials in
       data collected                                                                      early development
       Pavel Pisa, Traslational Medicine Leader, ROCHE                                  ●   Why early development is a good setting for adaptive clinical
                                                                                            trials?
17.00 Panel discussion: Developing clinical best practice in                            ●   Which early development trials are most suited for adaptive
      adaptive trials                                                                       clinical trials?
   ●   Co-ordinating the trial from a personnel perspective: avoiding the               ●   Finding the right balance between statistical rigor and practical
       pitfalls in order to create the most efficient strategy                              feasibility
   ●   Effective data management in an adaptive trial: maintaining the                  ●    What to worry about when considering a adaptive trial
       integrity of your trial by handling data effectively                             ●   Simulation as an indispensable tool to assess performance and
   ●   Focusing on the supply chain in order to reduce wastage and maximise                 feasibility at the design stage
       efficiency                                                                       ●   Exploring some case studies and analysing their outcomes
   ●   Do the benefits of adaptive trials outweigh the costs?                               Filip De Ridder, Director, Biostatistics and Programming,
   ●   What does the future hold for adaptive trials? Creating a clearer picture            JOHNSON & JOHNSON PHARMACEUTICAL R&D
       of their potential
       Pavel Pisa, Translational Medicine Leader, ROCHE                              18:00 End of Day One
       Bryan McDowell, Clinical Trial Head, Dermatology, NOVARTIS
       Michael Richter, Global Clinical Supply Coordinator, F. HOFFMANN
       LA-ROCHE
       Catarina Mattsson, Clinical Project Manager, ASTRAZENECA

18:00 End of Day One
Programme Day two                                                                 Wednesday 9 December 2009

8.30   Registration                                                                   ●   Analysing the lessons learned and looking at how they can be
                                                                                          implemented in the future
9.00   Opening remarks from the Chair                                                     Professor Andy Grieve, Department of Public Health Sciences, KING’S
                                                                                          COLLEGE LONDON
9.10   Roundtable morning sessions
       Round table discussions will enable delegates to choose                     14.30 Design and Analysis Issues for Multi-Armed Adaptive
       to join whichever debates are most relevant to their current                      Designs
       challenges. All delegates will have the opportunity to                         ●   Flexible adaptive designs: discussing the options
       participate in 3 different groups.                                             ●   Multiple testing in multi-armed adaptive designs: uncovering effective
                                                                                          treatment arms
       rounDtable 1:                                                                  ●   Sample size reassessment as an additional task: devising an optimum
                                                                                          strategy
       Making it work for you: can a seamless phase II/III save                       ●   Designing options relevant for assessing the statistical performance
       time and money?                                                                ●   Estimating the effect size in multi-armed designs
       Weighing up the opportunities and risks of a seamless trial with a             ●   The need for comprehensive and user friendly software
       view to reducing the risk involved                                                 Professor Gernot Wassmer, PhD., Institute for Medical Statistics,
       Catarina Mattsson, Clinical Project Manager, ASTRAZENECA                           University of Cologne and Managing Director, ADDPLAN

       rounDtable 2:
                                                                                   15.00 Case Study: How to design and manage a seamless
       The supply process                                                                phase II/III trial in order to maximise the potential cost
       An opportunity to develop a more thorough knowledge of the best
                                                                                         saving
       method to reduce overage and avoid inefficacies
                                                                                      ●   Under what circumstances is a phase II/III trial viable and beneficial?
       Thomas Kerbusch, Section Head PK-PD, SCHERING PLOUGH
                                                                                      ●   Scrutinising the design process: what was learned and what would we
                                                                                          do differently?
       rounDtable 3:                                                                  ●   Overcoming challenges during the trial’s execution: what issues came
       Statistical solutions: how does the design process                                 up, why did they arise and how can they be avoided?
       differ?                                                                         ●   The regulatory response: the key to a successful submission
       Answering your questions on trial design and debating areas of                 ●   Assessing how the write up and the next stages of drug development
       concern with statisticians from across the therapeutic spectrum and                are affected by choosing an adaptive trial
       with experience in different areas of adaptive trials.                             Marc Vandemeulebroecke, Expert Statistician, NOVARTIS
       Hans Ulrich Burger, Biostatistics section leader, ROCHE
                                                                                   15.30 Afternoon refreshments
       rounDtable 4:
       When is adaptive design appropriate?                                        establishinG the business case for aDaptive
       A chance for clinicians and statisticians to discuss the medical and        trials: unDerstanDinG the financial risks anD
       statistical characteristics of a trial that is well suited to an adaptive
                                                                                   benefits in orDer to MaxiMise the opportunity
       approach
       Marc Vandemeulebroecke, Expert Statistician, NOVARTIS                       for efficiency

       rounDtable 5:                                                               16.00 Taking a broad view: making adaptive designs work for you
                                                                                      ●   Learning practical lessons from case studies of adaptive trials and
       Trial management logistics: co-ordinating a more                                   relevant traditionally designed trials
       complex operation                                                              ●   Planning for the right decisions at early and final analyses
       Ascertaining best practice in communication, training, and reporting           ●   Combining clinical, statistical, regulatory, commercial and operational
       and ensuring that you are able to achieve the speed necessary to                   concerns to design the best trial
       maximise the advantages of an adaptive trial                                   ●   Weighing the savings against the additional complexity of an adaptive
       Christian Sonasson, Information Science Officer, ASTRAZENECA                       design
                                                                                          Robert Cuffe, Principal Statistician, Infectious Diseases Medicine
       rounDtable 6:                                                                      Development Centre, GSK

       Regulation in adaptive trials: establishing what works                      16.30 Panel discussion: Assessing the business viability of
       and what doesn’t                                                                  adaptive trials in all phases
       An opportunity to discuss the new guidelines and share experience
                                                                                      ●   Does the time saved during the execution of the trial justify the extra
       regarding how to reduce the regulatory risk involved in an adaptive trial
                                                                                          time taken during the design process?
       Prof Bruno Flamion, FEDERAL AGENCY FOR MEDICINES AND HEALTH
                                                                                      ●   What is the potential for time savings and what savings are actually
       PRODUCTS, BELGIUM
                                                                                          being achieved?
                                                                                      ●   Examining where improvements could be made in order to enable
12.30 Lunch                                                                               adaptive trials to reach their time-saving potential
                                                                                      ●   Can time and money be saved on recruitment or does the increased
key case stuDies: pavinG the way for your                                                 complexity of the operation cancel out potential efficiency gains from
                                                                                          running seamless trials or ending trials early?
future efficiencies
                                                                                      ●   The supply chain: has the drug supply and distribution process proved
                                                                                          cheaper than it would be with a traditional trial of similar scale?
14.00 Case Study: Implementing a complex Bayesian adaptive                            ●   Applying this knowledge to future trials: do adaptive trials save money
      design in drug development                                                          and time and how can the savings be maximised?
   ●   The importance of understanding the dose–response for successful                   Hans Ulrich Burger, Biostatistics Section Leader, ROCHE
       drug development                                                                   Thomas Kerbusch, Section Head PK-PD, SCHERING PLOUGH
   ●   Efficient characterisation of dose-response                                        Dr Patrick Johnson, Statistician, VIFOR PHARMA
   ●   Planning the study: including regulatory interactions                              Pavel Pisa, Translational Medicine Leader, ROCHE
   ●   Study results and learnings
   ●   Avoiding key pitfalls: focusing on the challenges and how they were
       overcome in order to develop effective strategies for the future            17.00 Closing remarks from the Chair and close of Day One
pre-conference workshop                                                  silver sponsor
                                                                                                       Cmed provides CRO services and
Adaptive and Group                                                                                     unique clinical data technology.

Sequential Designs
                                                                                                       Services include: clinical project
                                                                         management and monitoring, data management (eDC/paper)
                                                                         and statistical services. Cmed is rapidly gaining a reputation for
Professor Chris Jennison, University of Bath                             leadership in the adaptive trial design community through its
                                                                         unrivalled ability to conduct complicated adaptive design studies
The workshop will introduce adaptive and group sequential
                                                                         using patented intelligent data acquisition/management (iDAM)
methods for Phase II and Phase III clinical trials, with examples and
                                                                         technology. As Cmed combines both CRO services and technology
opportunity for discussion of participants' own problems.
                                                                         within a single organisation it can execute these studies particularly
About the workshop:                                                      efficiently without sponsors to coordinate multiple service
The workshop will introduce adaptive designs which make it               providers. www.cmedresearch.com
possible to modify a clinical trial in mid-course. In Phase II,
treatment allocation rules can be based on the emerging shape of         sponsor
the dose-response curve. In Phase III, it is possible to modify design                              ADDPLAN GmbH was founded in 2002 by
while preserving the type I error rate. Factors that can be changed                                 Gernot Wassmer and Reinhard Eisebitt
include: sample size, treatment definition, primary endpoint, patient                               as a result of their collaboration with the
population, and the null hypothesis of superiority or non-inferiority.   aim to apply the theory of adaptive study design to clinical research.
Topics will be illustrated by examples and discussion of problems        The software package 'ADDPLAN Adaptive Designs - Plans and
posed by the participants.                                               Analyses' started as a loose collection of programmes for adaptive
                                                                         sample size calculation, which later were transformed uniformly
Workshop agenda                                                          into object oriented programming language and complemented by
                                                                         further modules for the simulation and analysis of adaptive trials. The
  9.30   Registration and coffee                                         current release ADDPLAN 5 MC comprises sample size reassessment
 10.00 Introduction and motivation                                       procedures, planning and analysis issues for adaptive treatment
                                                                         selection multiple comparison procedures, population enrichment
 10.15 Combination tests                                                 designs, and much more.
 10.30 Sample size modification for a nuisance                           MeDia partners
       parameter                                                                                       Pharmaceutical Business Review:
 10.45 Rescuing an under-powered study                                                                 The Business Review websites are your
                                                                                                       number one stop for all the latest news,
 11.00 The role of group sequential tests                                                              comment and industry information.
                                                                                                       Each Business Review website offers
 11.45 Switching from testing for superiority to non-
                                                                         content that is produced by a dedicated team of journalists and global
       inferiority
                                                                         industry experts. In addition to the free content made available on
 12.00 Open discussion of examples and problems                          the sites an intelligence store will provide you with premium market
                                                                         analysis reports from the leading global suppliers of market research
 12.30 Lunch                                                             and industry analysis. Pharmaceutical Business Review is the world's
  1.30   Testing multiple hypotheses                                     leading pharma website, being used by over 100,000 visitors every
                                                                         month. For further information contact jsharp@industryreview.com
  2.00   Mid-study changes to treatment or endpoint
  2.30   Enrichment: switching focus to a sub-population                                                World Pharmaceutical Frontiers:
                                                                          World Pharmaceutical Frontiers
                                                                                                        The pharmaceutical industry is changing
                                                                                                           www.worldpharmaceuticals.net


  3.00   Break                                                           fast. There are more regulations, technologies, faster product
  3.30   Adaptive dose allocation in Phase II trials                     launches and shorter product life cycles than ever before. World
                                                                         Pharmaceuticals frontiers is, and will continue to be, at the forefront
  4.00   Combining data from Phases II and III                            of these changes, so visit us at www.worldpharmaceuticals.net and
                                                                         stay up to date with all latest developments.
  4.15   Seamless Phase II/ Phase III trials: benefits vs
         logistics                                                                               ThePharmYard provides instant access
  4.30   Case studies and discussion                                                             to a unique database of specialist
                                                                                                 information which is particularly relevant
  5.00 Close of workshop                                                                         to individuals working within the medical
                                                                         and pharmaceutical industries around the world. Titles from a
                                                                         diverse range of independent publishers are available to purchase in
About the workshop leader
                                                                         electronic document format for immediate access.
Christopher Jennison is Professor of Statistics and Dean of the
                                                                         Visit www.ThePharmYard.com
Faculty of Science at the University of Bath, UK. He was awarded his
PhD from Cornell University for research into the sequential analysis
of clinical trials and he has continued to work in this area for the
                                                                         supportinG association
past 25 years. He has written widely, particularly with Professor                         The Society for Clinical Data Management is a
Bruce Turnbull, on group sequential methods and adaptive designs                          nonprofit professional organization dedicated to
for clinical trials and their 2000 book "Group Sequential Tests with                      promoting excellence in clinical data management
Applications to Clinical Trials" remains a key reference in this area.                    through professional development, education and
                                                                                          certification. Key products and programs include
                                                                                          Good Clinical Data Management Practices, webinars
Do you wish to exhibit your proDucts anD services at this
exclusive event?                                                         and online courses, CCDM certification, an annual executive-level
                                                                         Leadership Forum and an Annual Conference.Established in 1994,
If you want to be part of this leading industry event, please contact
                                                                         SCDM has more than 2,600 members with an interest in advancing
Paul Adams in our sponsorship team. Email: pauladams@arena-
                                                                         data management practices. For additional information, please visit
international.com or call: +44 (0) 20 7753 4259
                                                                         www.scdm.org
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       3rd Annual Adaptive Trials 2009, Tuesday 8 and Wednesday 9 December 2009, Brussels, Belgium

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                                                                                 VAT = €3,412.20            = €3,751                 = €4,005.10
    I cannot attend the conference but would like to                             €700 (VAT where            €700 (VAT where          €900 (VAT where
  receive the interactive CD-ROM                                                 applicable)                applicable)              applicable)                                                                 TMSG
                                                               Discount code if applicable _________________________________
Total
                                                               Discounts are at the discretion of Arena international and are not cumulative

Arena International Conference Delegate terms and conditions                                                                   5 General: You, your executive/s or your agents may not transfer or assign any of the rights or obligations of this
1 Scope of Agreement: These are the conditions of the contract between you, the Client (“You” and “your”) and                  Agreement (in whole or part) without our prior consent. Any attempt to resell, assign or transfer rights without our
Arena International Events Group (“Arena International Events Group”, “we”, “us” and “our”) governing your use of our          consent will entitle us to cancel the contract without liability to you.
services, including the conference registration as set out in your booking form. This agreement constitutes the entire         • This agreement is governed by and will be construed in accordance with English law and each party
agreement between Arena International Events Group and you. All prior agreements understandings and negotiations               irrevocably agrees that the courts of England will have the non-exclusive jurisdiction to deal with any disputes
and representations (save for fraudulent misrepresentation) whether oral or in writing are cancelled in their entirety. The    arising out of or in connection with this agreement.
terms of any other electronic communications will not form part of this agreement.                                             • Grant of Licence: If your booking includes the CD-ROM, you warrant that you will only use the CD-ROM for
2 Our commitment to you: Should the Event be cancelled or the location be changed for reasons or circumstances                 your business purposes and shall not, without our prior written consent, make available, copy, reproduce, transmit,
beyond our control, we reserve the right to reschedule the Event, including changing the location, upon written                disseminate, sell, licence, distribute, publish, broadcast or otherwise circulate the CD-ROM (or any part of it) to any
notice to you. Should the event fail to be rescheduled for any reason your refund shall not exceed the total charge            other person other than in accordance with these terms and conditions.
received by us from you.                                                                                                       • Arena International Events Group is subject to the UK Data Protection Act 1998 and is registered in the UK with the
3 Payment Terms: The Total Fees specified on the booking form are subject to an additional service charge of                    Information Commissioner to process your personal information. Our primary goal in collecting personal information
2.5% (“Service Charge”) applied to cover administration costs, and are exclusive of VAT and any other applicable               from you is to give you an enjoyable customised experience whilst allowing us to provide services and features that
sales tax which shall be payable in addition.                                                                                  most likely meet your needs. We collect certain personal information from you, which you give to us when using our
• Following completion and return of the booking form, full payment including Service Charge is required within                Sites and/or registering or subscribing for our products and services. We also collect certain personal data from other
five days from the invoice date or prior to the event if this is sooner. All registrants must provide a credit card number      group companies to whom you have given information through their websites. If you do not want us to continue using
as a guarantee at the time of booking. We reserve the right to charge your card in full if payment is not received in          this information please notify us at unsubscribe@arena-international.com. Any personal information supplied to SPG
accordance with these payment terms. We reserve the right to refuse admission if full payment is not received in               Media Ltd as part of this registration process and/or any other interaction with SPG Media Ltd will be collected, stored
accordance with these terms.                                                                                                   and used by SPG Media Ltd its subsidiaries, related companies or affiliates in accordance with the SPG Media Ltd
4 Cancellations: In the event of cancellation, 100% of the event fee is payable and non-refundable. All cancellation           Privacy Policy. Please email privacypolicy@arena-international.com for a copy of the SPG Media Ltd Privacy Policy.
requests must be submitted to us in writing. If we agree to your cancellation then all cancellation fees are payable           • The working language of the Event is English. Executives requiring an interpretation service must make their own
immediately after the acceptance of your cancellation in writing by us.                                                        arrangements at their own expense.
Arena International Events Group, a trading division of SPG Media Ltd. Registered Office: 55 North Wharf Road, London, W2 1LA, UK. Registered in England No. 01155599. www.arena-international.com

Delegate Details please photocopy form for multiple bookings
Mr/Mrs/Ms/Dr:                                                                         First Name:                                                                     Surname:
Email:                                                                                Tel:                                                                            Job Title:
Fax:                                                                                  Department:
Company Details
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Town:                                                                                 Postcode:                                                                       Country:
VAT Number:                                                                           Nature of Business:

Payment Details
Purchase Order No.

■ I enclose a cheque drawn on a UK bank (please make cheque payable to SPG Media Limited and write reference ADTR1209 on the reverse)
■ I will transfer payment to your Lloyds TSB account City Branch, London, UK: 01492549, sort code 30-00-02 (using reference ADTR1209)
■ I would like to pay with my credit card ■ Visa ■ Mastercard ■ AMEX ■ Maestro ■ Solo
Card Number:                                                                                                                  Expiry Date:                         Issue Date:                               CSV*:

Cardholder's Name:

Cardholder's Address:
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 ■ Yes, I have read and understood the terms and cancellations conditions and am happy to proceed with my registration


Signature                                                                                                                       Date

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Adaptive Trials

  • 1. Silver Sponsor: Sponsor: Organised by: 3rd Annual Adaptive Trials 2009 Tuesday 8 and Wednesday 9 December 2009, Brussels, Belgium Maximising the potential of your adaptive clinical trials KEYNOTE SPEAKERS: Sue-Jane Wang, Professor Andy Grieve, Assoc. Dir., ADAPTIVE Department of Public DESIGN, FDA Health Sciences, KING’S COLLEGE LONDON Michel Krams, Assistant Vice President, Adaptive Christian Sonasson, Clinical Trials, Clinical Information Science Office, This e Development WYETH vent i (provisional) ASTRAZENECA co-loc s ate with t d Catarina Mattsson, Bryan McDowell, Clinical Clinical Project Manager, Explo he Trial Head, Dermatology, ASTRAZENECA NOVARTIS ra Pavel Pisa, Translational Clinic tory Thomas Sudhop, Director Medicine Leader, ROCHE al Tria and Professor, Head of the Division for Scientific Philip De Ridder, Director, ls Services, BFARM JOHNSON AND JOHNSON Dr Solange Rohou, Director Hans Ulrich Burger, European Regulatory Biostatistics, Section Affairs, ASTRAZENECA Leader, ROCHE Alun Bedding, Director, THREE HIGHLIGHTS OF THE CONFERENCE GSK • Learn how new and existing regulations are shaping the future of adaptive trials • Analysis of seamless phase II/III adaptive trials and how their design TOP COMPANIES REPRESENTED and logistics can maximise the efficiency of your clinical trials • GlaxoSmithKline • Schering-Plough • Roche • Vifor Pharma • A selection of roundtable • Novartis • Johnson and discussions to enable you to • AstraZeneca Johnson exchange ideas and experiences on • Merck & Co all aspects of adaptive design Register now: Online: www.adaptivetrials-events.com/2009 Email: book@arena-international.com Tel: +44 (0)207 7753 4268 Fax: +44 (0)20 7915 9773
  • 2. Programme Day one Tuesday 8 December 2009 08.30 Registration in order maximise the likelihood of regulatory acceptance for seamless trials ● Highlighting the differences between regulatory bodies to ensure that 09.00 Opening remarks from the Chair global adaptive designs are compliant internationally ● Phase III: identifying safety concerns and data validity in late keynote openinG aDDress: phase trials ● Case studies to illustrate when an adaptive Phase III design is likely to 09.10 An industry update: defining the role of adaptive trials be acceptable in a difficult economic environment and identifying Thomas Sudhop, Director and Professor, Head of the Division for opportunities to use more efficient trial designs Scientific Services, BFARM ● Running an adaptive trial in an environment of restricted resources: Prof Bruno Flamion, FEDERAL AGENCY FOR MEDICINES AND HEALTH ascertaining how the recession is affecting the trials PRODUCTS, BELGIUM ● Analysing progression in adaptive trials: how is the format developing Ingvild Aaløkken, Head of Section, NMA and what trends are being observed and what does it mean for your strategy? 12.10 Case Study: Dissecting successful and unsuccessful ● An appraisal of this year’s trials: tracking the successes in order to submissions to identify business critical factors that identify opportunities enable you to succeed first time ● Forecasting how the adaptive market will progress in order to ascertain ● Analysing some unsuccessful attempts: identifying why the trials were areas of growth not approved and the lessons that were learned ● Key questions to be answered regarding adaptive trials and their ● Achieving regulatory acceptance: identifying the characteristics of an usefulness: identifying the lessons that need to be learned acceptable design Provisional Speaker: Michael Krams, Assistant Vice President, Adaptive ● The research process: ascertaining whether or not the trial is well suited Clinical Trials, Clinical Development, WYETH to an adaptive approach ● The design: how we went about fulfilling regulatory requirements DeDucinG what the reGulators want: ● Answering key questions from the agency: identifying areas of learninG their reQuireMent regulatory concern and redesigning the trial to take these into account ● Ensuring that interim analyses and final evaluation results in viable data 09.40 An update from the FDA: evaluating their position that meets the regulator’s approval Sue-Jane Wang, Assoc. Dir., ADAPTIVE DESIGN, FDA Dr Solange Rohou, Director European Regulatory Affairs, ASTRAZENECA Sue-Jane Wang will provide new insight into the FDA perspective of adaptive clinical trials and the scientific principles involved. The 12.40 Optimising your approach towards Real Time Data excusive content will help you to better understand the FDA attitude Collection, Management and Reporting in order to towards adaptive design and how they see the use of such trials developing in the future. streamline the data analysis process: ● How to use an eProtocol tool to create an effective protocol design 10.10 Adaptive clinical designs: understanding the evolving ● Developing In-stream DB development using CDISC/ODM XML Examining real-time data capture in adaptive trials: overcoming the interface between developers and the FDA and other ● challenges and creating the most effective possible stategy regulators ● Real-time simulations, analysis and decision making: establishing new ● Going for an adaptive clinical study design: a “strategic game” with a solutions corporate and a regulatory player Richard Young, Director, Business Development, Cmed ● Regulators on a learning curve: is it a deterrent for developers and how can the situation be improved? 13.10 Lunch ● Trading inherent uncertainty for added insight: a challenging approach for both sides but how can the risks be reduced? Stream A: Clinical Stream B: Statistics ● Trial simulations: developing joint roadmaps for handling clinical Establishing the Streamlining the design decision scenarios logistical implications process: setting the ● Analysing pre-scheduling collaborative reviews, discussion and reconsideration in adaptive designs of running a successful groundwork for running a ● Establishing U.S. developments: evolution of the FDA position since the adaptive trial seamless adaptive trial May 2006 Medical Device draft ● Understanding European regulatory frameworks: evolution of the EMEA 14.30 Case Study: 14.30 Designing an position since the March 2006 “Reflection Paper” Enabling an effective drug adaptive clinical trial: ● Developments at the ICH: towards a globalized position on adaptive designs supply and distribution analysing the costs and Hermann A. M. Mucke, H.M. PHARMA CONSULTANCY system: avoiding costly benefits from a statistics 10.40 The European regulator’s perspective on adaptive mistakes point of view ● Ensuring that the supply ● Uncovering the latest designs: Ensuring that your trial is accepted department is sufficiently developments in statistics in ● What are the NMA and EMEA looking for in adaptive trial submissions? capable of dealing with the adaptive trials and the lessons Developing a more thorough understanding of the key factors increased complexity of the that have been learned as the ● How can you make sure your submissions are successful? Establishing supply requirements for an number of completed trials the critical characteristics of a successful submission adaptive algorithm increase ● Examining European case studies to identify which have been ● Just in time delivery: ● Key considerations when successful and the characteristics which set them apart coordinating your approach designing an adaptive trial: ● Analysing areas of regulatory concern in late phase trials and identifying and avoiding overage and the preparing you for a new possible solutions accompanying financial and approach ● Forecasting the future for adaptive trials from a regulatory perspective logistical consequences ● Identifying the types of Ingvild Aaløkken, Head of Section, NMA ● If a dose arm is created or the adaptive trial and how to 11.10 Morning refreshments sample size changed, how can determine which variant is outage be effectively avoided? most suitable 11.40 Regulatory Panel discussion: An exclusive opportunity ● Setting up your IVRS systems to ● Determining the most cost to discover first hand what the regulators are looking cope with increased complexity: and time effective solution for for and what the future might hold with a view to the basis for an effective supply your drug clarifying your own approach chain ● Spotlight on resources: ● Analysing key requirements in early phase adaptive trials: a guide to ● Forecasting potential planning for the time reducing the regulatory risk of embarking on an adaptive design changes to dosage and people involved in ● Evaluating areas of concern and pinpointing the key considerations
  • 3. Programme Day one Tuesday 8 December 2009 levels and the patient profile: factoring in complexity in order to more designing an adaptive trial as opposed to a more traditional accurately control costs and reduce error format Michael Richter, Global Clinical Supply Coordinator, F. Hoffmann ● Use of Bayesian techniques in adaptive trials LA-ROCHE Alun Bedding, Director, GSK 15.00 The implementation of a seamless trial from inception 15.00 Establishing the roles of short term endpoints in to final report: running an effective trial clinical trials in order to plan more effectively ● Assessing what is required of your database: ensuring that you are ● Analysing the criteria for the use of a surrogate endpoint equipped to deal with the increased heterogeneity and quantity of data ● Short term endpoints in Phase II proof of concept studies and are able to access it quickly in order to record, and respond to, ● Incorporating short term endpoints in Phase II adaptive dose interim analysis finding ● Developing an effective strategy when planning your trial: avoiding ● Using a short term endpoint in a Phase III study with delayed costly mistakes response ● Understanding how electronic technology can shape adaptive clinical ● Short and long term endpoints in a seamless Phase II/III trial trials Professor Christopher Jennison, Statistics, Bath University ● Identifying common pitfalls and how they can best be avoided ● Understanding the logistics of the final report, how it differs from that 15.30 Data analysis and trial adaptation for dose-finding of a traditional trial and how to produce the best possible reports studies: making the right choices in order to Bryan McDowell Clinical Trial Head, Dermatology, NOVARTIS maximise efficiency ● Determining the appropriate type of adaptation: correctly 15.30 Coordination and trial planning: maximising the identifying which change should be made benefits of an adaptive design through effective ● Choosing the statistical analysis method taking the adaptive management nature of the trial into account ● Critical insight into the breakdown of people involved in an adaptive ● Analysing which outcomes can be used to identify a necessary rather than a traditional trial: preparing for a more flexible operation adaptation: early outcomes, primary endpoints and safety ● Coordinating more people under increased time pressure: maximising results your efficiency in order to take best advantage of the potential benefits ● What are the implications for the logistics of the trial? ● Ensuring that your study managers are equipped to deal with adaptive ● Clarifying how to implement early stopping possibilities of an trials: establishing the training implications adaptive trial in order to save money without compromising the ● Adapting communication strategy to ensure that with increased trial’s integrity numbers of investigators involved, protocol amendments can be made Frank Miller, Principal Scientist, Statistics & Informatics, quickly in order to save time and resources AstraZeneca R&D Catarina Mattsson, Clinical Project Manager, ASTRAZENECA 16.00 Afternoon refreshments 16.00 Afternoon refreshments 16.30 Case study: Phase II adaptive design: worked 16.30 Effectively managing patients during a complex example using prior data and optimal design adaptive trial theory ● Maximising the potential for increased efficiency in recruitment: ● Understanding the main aims of Phase II including minimising the necessary patient numbers and devising an effective characterising dose-response and appropriate dose-selection system for maintaining the optimum number of patients as the needs ● Adaptive designs based on dose re-selection after collecting of the trial change some initial data appear attractive: analysing the potential ● Creating and maintaining a fast and efficient communication strategy benefits capable of ensuring that your investigators and patients are fully aware ● Revealing more about an adaptive design that addresses the of what the trial requires of them following issues: ● Ensuring that data collected during interim analysis does not ● Initial dose-selection compromise the trial’s blindness in order to meet the requirements of ● Parametric model fitting to this initial data supported with the regulator prior ● Randomisation challenges: as dosage arms change how can ● data from a drug with the same MOA randomisation be effectively achieved? ● Final stage doses selected using optimal design theory ● The implications for patient information: ensuring that your patient is Dr Patrick Johnson, Statistician, VIFOR PHARMA aware of the logistical implications of participation in an adaptive trial in order to reduce patient drop out and maintain the integrity of the 17.00 Maximizing the usefulness of adaptive trials in data collected early development Pavel Pisa, Traslational Medicine Leader, ROCHE ● Why early development is a good setting for adaptive clinical trials? 17.00 Panel discussion: Developing clinical best practice in ● Which early development trials are most suited for adaptive adaptive trials clinical trials? ● Co-ordinating the trial from a personnel perspective: avoiding the ● Finding the right balance between statistical rigor and practical pitfalls in order to create the most efficient strategy feasibility ● Effective data management in an adaptive trial: maintaining the ● What to worry about when considering a adaptive trial integrity of your trial by handling data effectively ● Simulation as an indispensable tool to assess performance and ● Focusing on the supply chain in order to reduce wastage and maximise feasibility at the design stage efficiency ● Exploring some case studies and analysing their outcomes ● Do the benefits of adaptive trials outweigh the costs? Filip De Ridder, Director, Biostatistics and Programming, ● What does the future hold for adaptive trials? Creating a clearer picture JOHNSON & JOHNSON PHARMACEUTICAL R&D of their potential Pavel Pisa, Translational Medicine Leader, ROCHE 18:00 End of Day One Bryan McDowell, Clinical Trial Head, Dermatology, NOVARTIS Michael Richter, Global Clinical Supply Coordinator, F. HOFFMANN LA-ROCHE Catarina Mattsson, Clinical Project Manager, ASTRAZENECA 18:00 End of Day One
  • 4. Programme Day two Wednesday 9 December 2009 8.30 Registration ● Analysing the lessons learned and looking at how they can be implemented in the future 9.00 Opening remarks from the Chair Professor Andy Grieve, Department of Public Health Sciences, KING’S COLLEGE LONDON 9.10 Roundtable morning sessions Round table discussions will enable delegates to choose 14.30 Design and Analysis Issues for Multi-Armed Adaptive to join whichever debates are most relevant to their current Designs challenges. All delegates will have the opportunity to ● Flexible adaptive designs: discussing the options participate in 3 different groups. ● Multiple testing in multi-armed adaptive designs: uncovering effective treatment arms rounDtable 1: ● Sample size reassessment as an additional task: devising an optimum strategy Making it work for you: can a seamless phase II/III save ● Designing options relevant for assessing the statistical performance time and money? ● Estimating the effect size in multi-armed designs Weighing up the opportunities and risks of a seamless trial with a ● The need for comprehensive and user friendly software view to reducing the risk involved Professor Gernot Wassmer, PhD., Institute for Medical Statistics, Catarina Mattsson, Clinical Project Manager, ASTRAZENECA University of Cologne and Managing Director, ADDPLAN rounDtable 2: 15.00 Case Study: How to design and manage a seamless The supply process phase II/III trial in order to maximise the potential cost An opportunity to develop a more thorough knowledge of the best saving method to reduce overage and avoid inefficacies ● Under what circumstances is a phase II/III trial viable and beneficial? Thomas Kerbusch, Section Head PK-PD, SCHERING PLOUGH ● Scrutinising the design process: what was learned and what would we do differently? rounDtable 3: ● Overcoming challenges during the trial’s execution: what issues came Statistical solutions: how does the design process up, why did they arise and how can they be avoided? differ? ● The regulatory response: the key to a successful submission Answering your questions on trial design and debating areas of ● Assessing how the write up and the next stages of drug development concern with statisticians from across the therapeutic spectrum and are affected by choosing an adaptive trial with experience in different areas of adaptive trials. Marc Vandemeulebroecke, Expert Statistician, NOVARTIS Hans Ulrich Burger, Biostatistics section leader, ROCHE 15.30 Afternoon refreshments rounDtable 4: When is adaptive design appropriate? establishinG the business case for aDaptive A chance for clinicians and statisticians to discuss the medical and trials: unDerstanDinG the financial risks anD statistical characteristics of a trial that is well suited to an adaptive benefits in orDer to MaxiMise the opportunity approach Marc Vandemeulebroecke, Expert Statistician, NOVARTIS for efficiency rounDtable 5: 16.00 Taking a broad view: making adaptive designs work for you ● Learning practical lessons from case studies of adaptive trials and Trial management logistics: co-ordinating a more relevant traditionally designed trials complex operation ● Planning for the right decisions at early and final analyses Ascertaining best practice in communication, training, and reporting ● Combining clinical, statistical, regulatory, commercial and operational and ensuring that you are able to achieve the speed necessary to concerns to design the best trial maximise the advantages of an adaptive trial ● Weighing the savings against the additional complexity of an adaptive Christian Sonasson, Information Science Officer, ASTRAZENECA design Robert Cuffe, Principal Statistician, Infectious Diseases Medicine rounDtable 6: Development Centre, GSK Regulation in adaptive trials: establishing what works 16.30 Panel discussion: Assessing the business viability of and what doesn’t adaptive trials in all phases An opportunity to discuss the new guidelines and share experience ● Does the time saved during the execution of the trial justify the extra regarding how to reduce the regulatory risk involved in an adaptive trial time taken during the design process? Prof Bruno Flamion, FEDERAL AGENCY FOR MEDICINES AND HEALTH ● What is the potential for time savings and what savings are actually PRODUCTS, BELGIUM being achieved? ● Examining where improvements could be made in order to enable 12.30 Lunch adaptive trials to reach their time-saving potential ● Can time and money be saved on recruitment or does the increased key case stuDies: pavinG the way for your complexity of the operation cancel out potential efficiency gains from running seamless trials or ending trials early? future efficiencies ● The supply chain: has the drug supply and distribution process proved cheaper than it would be with a traditional trial of similar scale? 14.00 Case Study: Implementing a complex Bayesian adaptive ● Applying this knowledge to future trials: do adaptive trials save money design in drug development and time and how can the savings be maximised? ● The importance of understanding the dose–response for successful Hans Ulrich Burger, Biostatistics Section Leader, ROCHE drug development Thomas Kerbusch, Section Head PK-PD, SCHERING PLOUGH ● Efficient characterisation of dose-response Dr Patrick Johnson, Statistician, VIFOR PHARMA ● Planning the study: including regulatory interactions Pavel Pisa, Translational Medicine Leader, ROCHE ● Study results and learnings ● Avoiding key pitfalls: focusing on the challenges and how they were overcome in order to develop effective strategies for the future 17.00 Closing remarks from the Chair and close of Day One
  • 5. pre-conference workshop silver sponsor Cmed provides CRO services and Adaptive and Group unique clinical data technology. Sequential Designs Services include: clinical project management and monitoring, data management (eDC/paper) and statistical services. Cmed is rapidly gaining a reputation for Professor Chris Jennison, University of Bath leadership in the adaptive trial design community through its unrivalled ability to conduct complicated adaptive design studies The workshop will introduce adaptive and group sequential using patented intelligent data acquisition/management (iDAM) methods for Phase II and Phase III clinical trials, with examples and technology. As Cmed combines both CRO services and technology opportunity for discussion of participants' own problems. within a single organisation it can execute these studies particularly About the workshop: efficiently without sponsors to coordinate multiple service The workshop will introduce adaptive designs which make it providers. www.cmedresearch.com possible to modify a clinical trial in mid-course. In Phase II, treatment allocation rules can be based on the emerging shape of sponsor the dose-response curve. In Phase III, it is possible to modify design ADDPLAN GmbH was founded in 2002 by while preserving the type I error rate. Factors that can be changed Gernot Wassmer and Reinhard Eisebitt include: sample size, treatment definition, primary endpoint, patient as a result of their collaboration with the population, and the null hypothesis of superiority or non-inferiority. aim to apply the theory of adaptive study design to clinical research. Topics will be illustrated by examples and discussion of problems The software package 'ADDPLAN Adaptive Designs - Plans and posed by the participants. Analyses' started as a loose collection of programmes for adaptive sample size calculation, which later were transformed uniformly Workshop agenda into object oriented programming language and complemented by further modules for the simulation and analysis of adaptive trials. The 9.30 Registration and coffee current release ADDPLAN 5 MC comprises sample size reassessment 10.00 Introduction and motivation procedures, planning and analysis issues for adaptive treatment selection multiple comparison procedures, population enrichment 10.15 Combination tests designs, and much more. 10.30 Sample size modification for a nuisance MeDia partners parameter Pharmaceutical Business Review: 10.45 Rescuing an under-powered study The Business Review websites are your number one stop for all the latest news, 11.00 The role of group sequential tests comment and industry information. Each Business Review website offers 11.45 Switching from testing for superiority to non- content that is produced by a dedicated team of journalists and global inferiority industry experts. In addition to the free content made available on 12.00 Open discussion of examples and problems the sites an intelligence store will provide you with premium market analysis reports from the leading global suppliers of market research 12.30 Lunch and industry analysis. Pharmaceutical Business Review is the world's 1.30 Testing multiple hypotheses leading pharma website, being used by over 100,000 visitors every month. For further information contact jsharp@industryreview.com 2.00 Mid-study changes to treatment or endpoint 2.30 Enrichment: switching focus to a sub-population World Pharmaceutical Frontiers: World Pharmaceutical Frontiers The pharmaceutical industry is changing www.worldpharmaceuticals.net 3.00 Break fast. There are more regulations, technologies, faster product 3.30 Adaptive dose allocation in Phase II trials launches and shorter product life cycles than ever before. World Pharmaceuticals frontiers is, and will continue to be, at the forefront 4.00 Combining data from Phases II and III of these changes, so visit us at www.worldpharmaceuticals.net and stay up to date with all latest developments. 4.15 Seamless Phase II/ Phase III trials: benefits vs logistics ThePharmYard provides instant access 4.30 Case studies and discussion to a unique database of specialist information which is particularly relevant 5.00 Close of workshop to individuals working within the medical and pharmaceutical industries around the world. Titles from a diverse range of independent publishers are available to purchase in About the workshop leader electronic document format for immediate access. Christopher Jennison is Professor of Statistics and Dean of the Visit www.ThePharmYard.com Faculty of Science at the University of Bath, UK. He was awarded his PhD from Cornell University for research into the sequential analysis of clinical trials and he has continued to work in this area for the supportinG association past 25 years. He has written widely, particularly with Professor The Society for Clinical Data Management is a Bruce Turnbull, on group sequential methods and adaptive designs nonprofit professional organization dedicated to for clinical trials and their 2000 book "Group Sequential Tests with promoting excellence in clinical data management Applications to Clinical Trials" remains a key reference in this area. through professional development, education and certification. Key products and programs include Good Clinical Data Management Practices, webinars Do you wish to exhibit your proDucts anD services at this exclusive event? and online courses, CCDM certification, an annual executive-level Leadership Forum and an Annual Conference.Established in 1994, If you want to be part of this leading industry event, please contact SCDM has more than 2,600 members with an interest in advancing Paul Adams in our sponsorship team. Email: pauladams@arena- data management practices. For additional information, please visit international.com or call: +44 (0) 20 7753 4259 www.scdm.org
  • 6. 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