Adaptive Trials


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Adaptive Clinical Trials will enable you to access new case studies and learn from the experiences of the increasing number of major pharma companies who have embarked on adaptive trials. The event is split into two streams in order to provide in-depth, targeted information for both a clinical and a statistical audience and is relevant across all therapeutic disciplines. The event will cover topics such as trial design, the practical implications of making an adaptation on the supply chain, along with data collection and analysis. There will also be extensive coverage and opportunities for debate on the latest industry guidelines.

If you are looking into using adaptive trials, would like to expand your knowledge, or are experienced in adaptive trials and would benefit from discussing key industry and regulatory developments with your peers, this a must attend event.

The event will consist of:

An update from the regulators on the latest guidelines and an appraisal of what they look for in adaptive design
A broad range of case studies from across all phases and therapeutic areas to give you an in depth knowledge of what is working and what isn’t
Carefully researched round table discussions designed to focus on the key questions you have about adaptive trials, their design and execution
An examination of the business case for adaptive trials. Do they save time and money?

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Adaptive Trials

  1. 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: Email: Tel: +44 (0)207 7753 4268 Fax: +44 (0)20 7915 9773
  2. 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. 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. 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. 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. 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 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 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 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 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 or call: +44 (0) 20 7753 4259
  6. 6. 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