Adaptive Designs in Clinical Trials

With a serious decline in only 1 in 10 drugs successfully passing phase II/III of clinical trials, there is increasing pressure to bring drugs quickly into the market and reduce the cost of drug development. This conference offers the perfect platform to hear strategies such as "Seamless Adaptive Designs" and "Group –Sequential Adaptive Designs" which are areas that improve the efficiency of drug development.

This conference will review the drug development process and provide a detailed discussion of how adaptive designs are changing the development process. The main focus of the presentation will be to explore the role of adaptive sample sizing; in particular, why it is important to consider the need to reassess sample sizes during the course of a trial.

Key Presentation Highlights include:

- Understand the objectives of Adaptive Licensing and MAPPs as the "breakthrough" designations to accelerate the approval of new medicines.
- Learn how Bayesian Belief Networks can support reliability management and decision making.
- Discover novel techniques in CARA and Seamless Adaptive Designs and Bayesian Bandit models to optimize efficiency in dosefinding strategies.
- Benefit from the talks of industry leaders and CEO’s in clinical leadership and how real world evidence can improve adaptive

PLUS TWO POST CONFERENCE INTERACTIVE WORKSHOP
(AM) Bayesian Adaptive Clinical Designs and Strategies
Workshop Leader: Dr. Sophie Carr, MD and Principal Analyst, Bays Consulting Ltd

(PM) Winning with Adaptive Trial Strategies and Clinical Compliance across the Evolving International Regulatory Landscape
Workshop Leader: Robert Clay, Consultant, Highbury Regulatory

Early bird saving:
Book before 19th December to save £400
Book before 30th January to save £200
Book before 27th February to save £100

Speakers: Dr. Graham Clarke, Senior Director and Head of Respiratory & Inflammation Early Clinical Development, Quintiles, Robert Clay, Consultant, Highbury Regulatory Science, Chief Regulatory Officer, Kinapse; Board Director, TOPRA, Professor Emeritus Tamás L. Paál, Faculty of Pharmacy, Institute of Drug Regulatory Affairs, University of Szeged, Hungary and Regulatory Adviser, Hungarian Medicines Agency, Dr. Sophie Carr, MD and Principal Analyst, Bays Consulting Ltd, Loïc Darchy, Head of Statistical Methodology Group, Sanofi R&D, Han-Joo Kim, PhD, Associate Director, Biostatistics, Oncology PCU, Eisai Inc