adaptive trials

KEYNOTE SPEAKERS:Sue-Jane Wang, Assoc. Dir., ADAPTIVE DESIGN, FDA

Michel Krams, Assistant Vice President, Adaptive Clinical Trials, Clinical Development WYETH (provisional)

Bryan McDowell, Clinical Trial Head, Dermatology, NOVARTIS

Thomas Sudhop, Director and Professor, Head of the Division for Scientifi c Services, BFARM

Dr Solange Rohou, Director European Regulatory Aff airs, ASTRAZENECA

Alun Bedding, Director, GSK

Professor Andy Grieve, Department of Public Health Sciences, KING’S COLLEGE LONDON

Christian Sonasson, Information Science Offi ce, ASTRAZENECA

Catarina Mattsson, Clinical Project Manager, ASTRAZENECA

Pavel Pisa, Translational Medicine Leader, ROCHE

Philip De Ridder, Director, JOHNSON AND JOHNSON

Hans Ulrich Burger, Biostatistics, Section Leader, ROCHE

THREE HIGHLIGHTS OF THE CONFERENCE

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 and logistics can maximise the effi ciency of your clinical trials

A • selection of roundtable discussions to enable you to exchange ideas and experiences on all aspects of adaptive design

TOP COMPANIES REPRESENTED

Tuesday 8 and Wednesday 9 December 2009, Brussels, Belgium

Adaptive Trials 20093rd Annual

Organised by:Silver Sponsor:

Register now: Online: www.adaptivetrials-events.com/2009 Email: [email protected]: +44 (0)207 7753 4268 Fax: +44 (0)20 7915 9773

THREE HIGHLIGHTS OF THE CONFERENCE

This event is co-located with the Exploratory Clinical Trials

Maximising the potential of your adaptive clinical trials

GlaxoSmithKline• Roche• Novartis• AstraZeneca• Merck • & Co

Schering-Plough• Vifor • PharmaJohnson • and Johnson

Sponsor:

Programme Day one Tuesday 8 December 2009

08.30 Registration

09.00 Opening remarks from the Chair

keynote openinG aDDress:09.10 An industry update: defi ning the role of adaptive trials

in a diffi cult economic environment and identifying opportunities to use more effi cient trial designsRunning an adaptive trial in an environment of restricted resources: ●

ascertaining how the recession is aff ecting the trialsAnalysing progression in adaptive trials: how is the format developing ●

and what trends are being observed and what does it mean for your strategy?An appraisal of this year’s trials: tracking the successes in order to ●

identify opportunitiesForecasting how the adaptive market will progress in order to ascertain ●

areas of growth Key questions to be answered regarding adaptive trials and their ●

usefulness: identifying the lessons that need to be learned Provisional Speaker: Michael Krams, Assistant Vice President, Adaptive Clinical Trials, Clinical Development, WYETH

DeDucinG what the reGulators want: learninG their reQuireMent09.40 An update from the FDA: evaluating their position

Sue-Jane Wang, Assoc. Dir., ADAPTIVE DESIGN, FDA Sue-Jane Wang will provide new insight into the FDA perspective of adaptive clinical trials and the scientific principles involved. The excusive content will help you to better understand the FDA attitude towards adaptive design and how they see the use of such trials developing in the future.

10.10 Adaptive clinical designs: understanding the evolving interface between developers and the FDA and other regulatorsGoing for an adaptive clinical study design: a “strategic game” with a ●

corporate and a regulatory player Regulators on a learning curve: is it a deterrent for developers and how ●

can the situation be improved? Trading inherent uncertainty for added insight: a challenging approach ●

for both sides but how can the risks be reduced? Trial simulations: developing joint roadmaps for handling clinical ●

decision scenarios Analysing pre-scheduling collaborative reviews, discussion and ●

reconsideration in adaptive designs Establishing U.S. developments: evolution of the FDA position since the ●

May 2006 Medical Device draft Understanding European regulatory frameworks: evolution of the EMEA ●

position since the March 2006 “Refl ection Paper” Developments at the ICH: towards a globalized position on adaptive designs ●

Hermann A. M. Mucke, H.M. PHARMA CONSULTANCY

10.40 The European regulator’s perspective on adaptive designs: Ensuring that your trial is acceptedWhat are the NMA and EMEA looking for in adaptive trial submissions? ●

Developing a more thorough understanding of the key factors How can you make sure your submissions are successful? Establishing ●

the critical characteristics of a successful submission Examining European case studies to identify which have been ●

successful and the characteristics which set them apart Analysing areas of regulatory concern in late phase trials and identifying ●

possible solutions Forecasting the future for adaptive trials from a regulatory perspective ●

Ingvild Aaløkken, Head of Section, NMA

11.10 Morning refreshments11.40 Regulatory Panel discussion: An exclusive opportunity

to discover fi rst hand what the regulators are looking for and what the future might hold with a view to clarifying your own approachAnalysing key requirements in early phase adaptive trials: a guide to ●

reducing the regulatory risk of embarking on an adaptive design Evaluating areas of concern and pinpointing the key considerations ●

in order maximise the likelihood of regulatory acceptance for seamless trials Highlighting the diff erences between regulatory bodies to ensure that ●

global adaptive designs are compliant internationally Phase III: identifying safety concerns and data validity in late ●

phase trials Case studies to illustrate when an adaptive Phase III design is likely to ●

be acceptableThomas Sudhop, Director and Professor, Head of the Division for Scientific Services, BFARMProf Bruno Flamion, FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS, BELGIUMIngvild Aaløkken, Head of Section, NMA

12.10 Case Study: Dissecting successful and unsuccessful submissions to identify business critical factors that enable you to succeed fi rst timeAnalysing some unsuccessful attempts: identifying why the trials were ●

not approved and the lessons that were learned Achieving regulatory acceptance: identifying the characteristics of an ●

acceptable design The research process: ascertaining whether or not the trial is well suited ●

to an adaptive approachThe design: how we went about fulfi lling regulatory requirements ●

Answering key questions from the agency: identifying areas of ●

regulatory concern and redesigning the trial to take these into accountEnsuring that interim analyses and fi nal evaluation results in viable data ●

that meets the regulator’s approvalDr Solange Rohou, Director European Regulatory Affairs, ASTRAZENECA

12.40 Optimising your approach towards Real Time Data Collection, Management and Reporting in order to streamline the data analysis process:How to use an eProtocol tool to create an eff ective protocol design ●

Developing In-stream DB development using CDISC/ODM XML ●

Examining real-time data capture in adaptive trials: overcoming the ●

challenges and creating the most eff ective possible stategyReal-time simulations, analysis and decision making: establishing new ●

solutionsRichard Young, Director, Business Development, Cmed

13.10 Lunch

Stream A: ClinicalEstablishing the logistical implications of running a successful adaptive trial

Stream B: StatisticsStreamlining the design process: setting the groundwork for running a seamless adaptive trial

14.30 Case Study: Enabling an eff ective drug supply and distribution system: avoiding costly mistakes

Ensuring that the supply ●

department is suffi ciently capable of dealing with the increased complexity of the supply requirements for an adaptive algorithm Just in time delivery: ●

coordinating your approach and avoiding overage and the accompanying fi nancial and logistical consequences If a dose arm is created or the ●

sample size changed, how can outage be eff ectively avoided? Setting up your IVRS systems to ●

cope with increased complexity: the basis for an eff ective supply chain

Forecasting potential ●

changes to dosage

14.30 Designing an adaptive clinical trial: analysing the costs and benefi ts from a statistics point of view

Uncovering the latest ●

developments in statistics in adaptive trials and the lessons that have been learned as the number of completed trials increase Key considerations when ●

designing an adaptive trial: preparing you for a new approach Identifying the types of ●

adaptive trial and how to determine which variant is most suitable Determining the most cost ●

and time eff ective solution for your drug

Spotlight on resources: ●

planning for the time and people involved in

Programme Day one Tuesday 8 December 2009

levels and the patient profi le: factoring in complexity in order to more accurately control costs and reduce errorMichael Richter, Global Clinical Supply Coordinator, F. Hoffmann LA-ROCHE

15.00 The implementation of a seamless trial from inception to fi nal report: running an eff ective trialAssessing what is required of your database: ensuring that you are ●

equipped to deal with the increased heterogeneity and quantity of data and are able to access it quickly in order to record, and respond to, interim analysis Developing an eff ective strategy when planning your trial: avoiding ●

costly mistakes Understanding how electronic technology can shape adaptive clinical ●

trials Identifying common pitfalls and how they can best be avoided ●

Understanding the logistics of the fi nal report, how it diff ers from that ●

of a traditional trial and how to produce the best possible reportsBryan McDowell Clinical Trial Head, Dermatology, NOVARTIS

15.30 Coordination and trial planning: maximising the benefi ts of an adaptive design through eff ective managementCritical insight into the breakdown of people involved in an adaptive ●

rather than a traditional trial: preparing for a more fl exible operation Coordinating more people under increased time pressure: maximising ●

your effi ciency in order to take best advantage of the potential benefi ts Ensuring that your study managers are equipped to deal with adaptive ●

trials: establishing the training implications Adapting communication strategy to ensure that with increased ●

numbers of investigators involved, protocol amendments can be made quickly in order to save time and resourcesCatarina Mattsson, Clinical Project Manager, ASTRAZENECA

16.00 Afternoon refreshments16.30 Eff ectively managing patients during a complex

adaptive trialMaximising the potential for increased effi ciency in recruitment: ●

minimising the necessary patient numbers and devising an eff ective system for maintaining the optimum number of patients as the needs of the trial change Creating and maintaining a fast and effi cient communication strategy ●

capable of ensuring that your investigators and patients are fully aware of what the trial requires of them Ensuring that data collected during interim analysis does not ●

compromise the trial’s blindness in order to meet the requirements of the regulator Randomisation challenges: as dosage arms change how can ●

randomisation be eff ectively achieved? The implications for patient information: ensuring that your patient is ●

aware of the logistical implications of participation in an adaptive trial in order to reduce patient drop out and maintain the integrity of the data collectedPavel Pisa, Traslational Medicine Leader, ROCHE

17.00 Panel discussion: Developing clinical best practice in adaptive trialsCo-ordinating the trial from a personnel perspective: avoiding the ●

pitfalls in order to create the most effi cient strategyEff ective data management in an adaptive trial: maintaining the ●

integrity of your trial by handling data eff ectivelyFocusing on the supply chain in order to reduce wastage and maximise ●

effi ciencyDo the benefi ts of adaptive trials outweigh the costs? ●

What does the future hold for adaptive trials? Creating a clearer picture ●

of their potentialPavel Pisa, Translational Medicine Leader, ROCHEBryan McDowell, Clinical Trial Head, Dermatology, NOVARTISMichael Richter, Global Clinical Supply Coordinator, F. HOFFMANN LA-ROCHECatarina Mattsson, Clinical Project Manager, ASTRAZENECA

18:00 End of Day One

designing an adaptive trial as opposed to a more traditional format Use of Bayesian techniques in adaptive trials ●

Alun Bedding, Director, GSK

15.00 Establishing the roles of short term endpoints in clinical trials in order to plan more eff ectivelyAnalysing the criteria for the use of a surrogate endpoint ●

Short term endpoints in Phase II proof of concept studies ●

Incorporating short term endpoints in Phase II adaptive dose ●

fi ndingUsing a short term endpoint in a Phase III study with delayed ●

responseShort and long term endpoints in a seamless Phase II/III trial ●

Professor Christopher Jennison, Statistics, Bath University

15.30 Data analysis and trial adaptation for dose-fi nding studies: making the right choices in order to maximise effi ciencyDetermining the appropriate type of adaptation: correctly ●

identifying which change should be made Choosing the statistical analysis method taking the adaptive ●

nature of the trial into account Analysing which outcomes can be used to identify a necessary ●

adaptation: early outcomes, primary endpoints and safety results What are the implications for the logistics of the trial? ●

Clarifying how to implement early stopping possibilities of an ●

adaptive trial in order to save money without compromising the trial’s integrityFrank Miller, Principal Scientist, Statistics & Informatics, AstraZeneca R&D

16.00 Afternoon refreshments16.30 Case study: Phase II adaptive design: worked

example using prior data and optimal design theoryUnderstanding the main aims of Phase II including ●

characterising dose-response and appropriate dose-selection Adaptive designs based on dose re-selection after collecting ●

some initial data appear attractive: analysing the potential benefi ts Revealing more about an adaptive design that addresses the ●

following issues: Initial dose-selection ●

Parametric model fi tting to this initial data supported with ●

priordata from a drug with the same MOA ●

Final stage doses selected using optimal design theory ●

Dr Patrick Johnson, Statistician, VIFOR PHARMA

17.00 Maximizing the usefulness of adaptive trials in early development Why early development is a good setting for adaptive clinical ●

trials?Which early development trials are most suited for adaptive ●

clinical trials?Finding the right balance between statistical rigor and practical ●

feasibility What to worry about when considering a adaptive trial ●

Simulation as an indispensable tool to assess performance and ●

feasibility at the design stageExploring some case studies and analysing their outcomes ●

Filip De Ridder, Director, Biostatistics and Programming, JOHNSON & JOHNSON PHARMACEUTICAL R&D

18:00 End of Day One

8.30 Registration

9.00 Opening remarks from the Chair

9.10 Roundtable morning sessionsRound table discussions will enable delegates to choose to join whichever debates are most relevant to their current challenges. All delegates will have the opportunity to participate in 3 diff erent groups.

rounDtable 1: Making it work for you: can a seamless phase II/III save time and money?Weighing up the opportunities and risks of a seamless trial with a view to reducing the risk involvedCatarina Mattsson, Clinical Project Manager, ASTRAZENECA

rounDtable 2: The supply processAn opportunity to develop a more thorough knowledge of the best method to reduce overage and avoid ineffi caciesThomas Kerbusch, Section Head PK-PD, SCHERING PLOUGH

rounDtable 3: Statistical solutions: how does the design process diff er?Answering your questions on trial design and debating areas of concern with statisticians from across the therapeutic spectrum and with experience in diff erent areas of adaptive trials. Hans Ulrich Burger, Biostatistics section leader, ROCHE

rounDtable 4: When is adaptive design appropriate? A chance for clinicians and statisticians to discuss the medical and statistical characteristics of a trial that is well suited to an adaptive approachMarc Vandemeulebroecke, Expert Statistician, NOVARTIS

rounDtable 5: Trial management logistics: co-ordinating a more complex operationAscertaining best practice in communication, training, and reporting and ensuring that you are able to achieve the speed necessary to maximise the advantages of an adaptive trialChristian Sonasson, Information Science Officer, ASTRAZENECA

rounDtable 6: Regulation in adaptive trials: establishing what works and what doesn’tAn opportunity to discuss the new guidelines and share experience regarding how to reduce the regulatory risk involved in an adaptive trialProf Bruno Flamion, FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS, BELGIUM

12.30 Lunch

key case stuDies: pavinG the way for your future efficiencies

14.00 Case Study: Implementing a complex Bayesian adaptive design in drug developmentThe importance of understanding the dose–response for successful ●

drug developmentEffi cient characterisation of dose-response ●

Planning the study: including regulatory interactions ●

Study results and learnings ●

Avoiding key pitfalls: focusing on the challenges and how they were ●

overcome in order to develop eff ective strategies for the future

Analysing the lessons learned and looking at how they can be ●

implemented in the futureProfessor Andy Grieve, Department of Public Health Sciences, KING’S COLLEGE LONDON

14.30 Design and Analysis Issues for Multi-Armed Adaptive DesignsFlexible adaptive designs: discussing the options ●

Multiple testing in multi-armed adaptive designs: uncovering eff ective ●

treatment arms Sample size reassessment as an additional task: devising an optimum ●

strategy Designing options relevant for assessing the statistical performance ●

Estimating the eff ect size in multi-armed designs ●

The need for comprehensive and user friendly software ●

Professor Gernot Wassmer, PhD., Institute for Medical Statistics, University of Cologne and Managing Director, ADDPLAN

15.00 Case Study: How to design and manage a seamless phase II/III trial in order to maximise the potential cost savingUnder what circumstances is a phase II/III trial viable and benefi cial? ●

Scrutinising the design process: what was learned and what would we ●

do diff erently?Overcoming challenges during the trial’s execution: what issues came ●

up, why did they arise and how can they be avoided?The regulatory response: the key to a successful submission ●

Assessing how the write up and the next stages of drug development ●

are aff ected by choosing an adaptive trialMarc Vandemeulebroecke, Expert Statistician, NOVARTIS

15.30 Afternoon refreshments

establishinG the business case for aDaptive trials: unDerstanDinG the financial risks anD benefits in orDer to MaxiMise the opportunity for efficiency

16.00 Taking a broad view: making adaptive designs work for youLearning practical lessons from case studies of adaptive trials and ●

relevant traditionally designed trialsPlanning for the right decisions at early and fi nal analyses ●

Combining clinical, statistical, regulatory, commercial and operational ●

concerns to design the best trialWeighing the savings against the additional complexity of an adaptive ●

designRobert Cuffe, Principal Statistician, Infectious Diseases Medicine Development Centre, GSK

16.30 Panel discussion: Assessing the business viability of adaptive trials in all phasesDoes the time saved during the execution of the trial justify the extra ●

time taken during the design process?What is the potential for time savings and what savings are actually ●

being achieved?Examining where improvements could be made in order to enable ●

adaptive trials to reach their time-saving potentialCan time and money be saved on recruitment or does the increased ●

complexity of the operation cancel out potential effi ciency gains from running seamless trials or ending trials early?The supply chain: has the drug supply and distribution process proved ●

cheaper than it would be with a traditional trial of similar scale?Applying this knowledge to future trials: do adaptive trials save money ●

and time and how can the savings be maximised?Hans Ulrich Burger, Biostatistics Section Leader, ROCHEThomas Kerbusch, Section Head PK-PD, SCHERING PLOUGHDr Patrick Johnson, Statistician, VIFOR PHARMAPavel Pisa, Translational Medicine Leader, ROCHE

17.00 Closing remarks from the Chair and close of Day One

Programme Day two Wednesday 9 December 2009

Do you wish to exhibit your proDucts anD services at this exclusive event?If you want to be part of this leading industry event, please contact Paul Adams in our sponsorship team. Email: [email protected] or call: +44 (0) 20 7753 4259

silver sponsor Cmed provides CRO services and unique clinical data technology. Services include: clinical project

management and monitoring, data management (eDC/paper) and statistical services. Cmed is rapidly gaining a reputation for leadership in the adaptive trial design community through its unrivalled ability to conduct complicated adaptive design studies using patented intelligent data acquisition/management (iDAM) technology. As Cmed combines both CRO services and technology within a single organisation it can execute these studies particularly efficiently without sponsors to coordinate multiple service providers. www.cmedresearch.com

sponsorADDPLAN GmbH was founded in 2002 by Gernot Wassmer and Reinhard Eisebitt as a result of their collaboration with the

aim to apply the theory of adaptive study design to clinical research. The software package 'ADDPLAN Adaptive Designs - Plans and Analyses' started as a loose collection of programmes for adaptive sample size calculation, which later were transformed uniformly into object oriented programming language and complemented by further modules for the simulation and analysis of adaptive trials. The current release ADDPLAN 5 MC comprises sample size reassessment procedures, planning and analysis issues for adaptive treatment selection multiple comparison procedures, population enrichment designs, and much more.

MeDia partnersPharmaceutical Business Review: The Business Review websites are your number one stop for all the latest news, comment and industry information. Each Business Review website offers

content that is produced by a dedicated team of journalists and global industry experts. In addition to the free content made available on the sites an intelligence store will provide you with premium market analysis reports from the leading global suppliers of market research and industry analysis. Pharmaceutical Business Review is the world's leading pharma website, being used by over 100,000 visitors every month. For further information contact [email protected]

World Pharmaceutical Frontiers: The pharmaceutical industry is changing

fast. There are more regulations, technologies, faster product launches and shorter product life cycles than ever before. World Pharmaceuticals frontiers is, and will continue to be, at the forefront of these changes, so visit us at www.worldpharmaceuticals.net and stay up to date with all latest developments.

ThePharmYard provides instant access to a unique database of specialist information which is particularly relevant 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 electronic document format for immediate access. Visit www.ThePharmYard.com

supportinG associationThe Society for Clinical Data Management is a nonprofit professional organization dedicated to promoting excellence in clinical data management through professional development, education and certification. Key products and programs include Good Clinical Data Management Practices, webinars

and online courses, CCDM certification, an annual executive-level Leadership Forum and an Annual Conference.Established in 1994, SCDM has more than 2,600 members with an interest in advancing data management practices. For additional information, please visit www.scdm.org

World Pharmaceutical Frontiers www.worldpharmaceuticals.net

pre-conference workshop

Adaptive and Group Sequential DesignsProfessor Chris Jennison, University of Bath

The workshop will introduce adaptive and group sequential methods for Phase II and Phase III clinical trials, with examples and opportunity for discussion of participants' own problems.

About the workshop: The workshop will introduce adaptive designs which make it possible to modify a clinical trial in mid-course. In Phase II, treatment allocation rules can be based on the emerging shape of the dose-response curve. In Phase III, it is possible to modify design while preserving the type I error rate. Factors that can be changed include: sample size, treatment definition, primary endpoint, patient population, and the null hypothesis of superiority or non-inferiority. Topics will be illustrated by examples and discussion of problems posed by the participants.

Workshop agenda

9.30 Registration and coffee

10.00 Introduction and motivation

10.15 Combination tests

10.30 Sample size modification for a nuisance parameter

10.45 Rescuing an under-powered study

11.00 The role of group sequential tests

11.45 Switching from testing for superiority to non-inferiority

12.00 Open discussion of examples and problems

12.30 Lunch

1.30 Testing multiple hypotheses

2.00 Mid-study changes to treatment or endpoint

2.30 Enrichment: switching focus to a sub-population

3.00 Break

3.30 Adaptive dose allocation in Phase II trials

4.00 Combining data from Phases II and III

4.15 Seamless Phase II/ Phase III trials: benefits vs logistics

4.30 Case studies and discussion

5.00 Close of workshop

About the workshop leader Christopher Jennison is Professor of Statistics and Dean of the 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 past 25 years. He has written widely, particularly with Professor Bruce Turnbull, on group sequential methods and adaptive designs for clinical trials and their 2000 book "Group Sequential Tests with Applications to Clinical Trials" remains a key reference in this area.

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adaptive trials

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