Adaptive Designs in Clinical Drug Development

About the workshop

The workshop describes the statistical principles for planning and conducting a multi-armed adaptive trial.  This includes an introduction into adaptive designs - what is meant by adaptive?  The focus of this workshop is on confirmatory adaptive designs mainly performed in phase II/III designs where control of Type I error rate is mandatory.  The ways of reaching a test decision, selecting treatment arms, calculating confidence intervals and p-values are described.  Finally, software for performing such analyses is presented and illustrated by examples.

About the host

Gernot Wassmer, Professor, Institute for Medical Statistics, Informatics and Epidemiology (IMSIE), University of Cologne Gernot Wassmer PhD is an Associate Professor for Biostatistics at the Institute of Medical Statistics at the University of Cologne in Germany.  He received his PhD in 1993 at the University of Munich, Germany.  From 1993-2000, he was a Research Fellow at the Institute of Statistics at the University of Munich, also at the Institute for Epidemiology, GSF Neuherberg, and at the Institute of Medical Statistics, University of Cologne.  He also works as a statistical consultant for the pharmaceutical industry.  His major research interest is in the field of statistical procedures for group sequential and adaptive plans in clinical trials.

 About the organisation

The University of Cologne is a research university at the highest level with more than 250 co-operating instututes and departments.  The Institute for Medical Statistics, Informatics and Epidemiology offers research, teaching services and consultancy with special emphasis on biometrical reserach and its applications in clinical trials.

In association with Cytel Inc
www.cytel.com

About the workshop

This half-day workshop will cover the latest techniques and software for accurate planning and successful execution of adaptive trials.
 
Join noted adaptive trial expert Yannis Jemiai for an in-depth look at the most effective approaches for planning and efficient implementation of adaptive trials.

In a wide-ranging format, Yannis will review current international regulatory attitudes, while also revealing methods and software specifically for planning and successfully running adaptive trials.

Actual early and confirmatory adaptive trial case studies will help illustrate how to overcome the challenges, and take full advantage of today's era of adaptive development.

Planning: how do you know you have a good design?

• Asking the right development questions - how to avoid racing towards the wrong answer
• The role of simulations during the design phase
• Assessing options and determining the best design
• Assessing the impact on the clinical development strategy
• Working with colleagues - preparing internally for success
• Working with regulators

Implementation: are you fully prepared to implement adaptive changes?

• The role of simulation during the execution phase
• Supply forecasting and cost analysis
• Forecasting site accrual rates
• Interim analysis - who sees what and when?
• Protecting trial integrity
• Implementing the recommended changes
• New adaptive randomisation schemes
• Final study data analysis considerations

About the host

Yannis Jemiai, Associate Director of Biostatistics, Cytel Inc Yannis has trained hundreds of statisticians and clinicians with Cytel, also consulting on early, confirmatory and seamless adaptive designs, survival studies, and trial data analysis strategies. Yannis also oversees the progression of East®, Cytel's widely used adaptive and group-sequential design software.  He is also responsible for the development of the recently introduced SiZ® software for fixed sample trial design simulation and analysis. Yannis is often invited to speak on innovative adaptive trial techniques and his own research has been published in numerous peer-reviewed statistical journals. Yannis earned his Ph.D. from Harvard University, an M.P.H. from Columbia University, and a B.A. in Molecular and Cellular Biology also from Harvard.

In association with Tessella
www.tessella.com

About the workshop

Workshop delegates will learn about the practical lessons learnt in the key stages of designing an adaptive clinical trial.  For each of the key stages in the design process (evaluation, comparison and optimisation), delegates will be given hands on experience in the design of a trial.  The workshop will concentrate on phase II designs and compare design issues such as:

• Response modelling of the endpoint - is a model worthwhile, what models can be considered?
• What adaptations you should consider during the trial: adaptive allocation, arm dropping, early stopping, none?
• Longitudinal modelling
• How to compare fixed and adaptive designs
• How to optimise the design

About the host

Tom Parke, Head, Clinical Trial Solutions, Tessella Tom has been working at Tessella for over ten years, during which he has been working on adaptive clinical trial projects, particularly with Dr Mike Krams and Don and Scott Berry.  Tom has now helped implement a number of adaptive phase II dose-finding trials for a range of pharmaceutical companies across a range of indications.  For these trials, he has managed the development of simulation tools, systems to support the running of the trials and the integration of adaptive algotrithms with existing IVRS and EDC systems. He is currently leading projects within Tessella to industrialise their support for adaptive trials and is consulting with a number of companies to help them define the software systems they require to move adaptive clinical trials into their mainstream activities. Before working at Tessella, Tom worked at Praxis (part of Deloitte & Touche), most notably managing projects for part of the air trafiic control system at Heathrow Airport, and control software for imaging systems for GE Medical Systems and Varian Oncology.  Tom originally learned his software trade at inmos (now part of SGS Thomson), and Imperial Software Technology, developing compilers, operating systems and real-time kernels and using formal methods

 About the organisation

For over 25 years, Tessella has worked with some of the biggest names in the pharmaceuitcal industry.  We help clients address a wide range of business goals, including improving efficiency and productivity in drug discovery, delivering the business benefits of translational medicine, and faster more effective clinical trials.  What makes our technoloy and consulting services effective is our understanding of both the sci=ence and informatics of pharmaceutical R&D, as well as unique software assts and intellectualy property that reduce project risk, cost and time.  With offices in Europe and North America, global companies rely on Tessella for business critical assignments.