Adaptive Designs: Concepts and Practical Considerations for Implementation 2014

As clinical development teams are working in an increasingly pressured and complex environment, they are looking toward different types of trial designs to address their development challenges.

This course will present key concepts in clinical trial designs, different types of design options (with a focus on adaptive designs), and their benefits as well as possible complexities. The trainer will employ East software as a design interface, demonstrating how the clinical team can visualize and evaluate the key operating characteristics of a design. Where ever possible, case examples from recent clinical trials will be used to help illustrate concepts and real-world application of the designs.

This workshop is intended for medical officers, biostatisticians, and core members of the clinical team who would like to better understand the range of trial designs available to them, and which are accepted by regulators. It will enable them to look beyond off-the-shelf designs and to consider options which would allow for patient savings, built-in flexibility, improved knowledge-return from a study, and an earlier time-to-market. The workshop will also inform the participants about methods they can use to better forecast the outcomes of a trial, and monitoring tools that can help them plan or adjust to trial changes.

Pantelis Vlachos is a Director of Strategic Consulting for Cytel, Inc. based in Geneva. He joined the company in January 2013. Before that, he was a Principal Biostatistician at Merck Serono as well as a Professor of Statistics at Carnegie Mellon University for 12 years. His research interests lie in the area of adaptive designs, mainly from a Bayesian perspective, as well as hierarchical model testing and checking although his secret passion is Text Mining. He is the Managing Editor of the journal 'Bayesian Analysis' and has served in the editorial boards of several other journals and online statistical data and software arc