Gardell, M.D., Ph.D.
Office Of Clinical Trials, Therapeutic Products Directorate, Health Canada
||Judith A. Quinlan, Ph.D.
Director Statistics, Biopharmaceuticals, GlaxoSmithKline
||Jerald S. Schindler, Dr.P.H.
Vice President, Biostatistics and Research Decision Sciences, Late Stage Clinical Development Statistics, Merck Research Laboratories
||Leslie C. Lilly, B.S.N., R.N.
Professionals from the following departments should attend
- Medical Research
- Clinical Operations
- Data Management
- Clinical Supplies
- Regulatory Affairs
- Government Regulators
- Portfolio Management
Scope of conference
The time and cost of developing new drugs is long and expensive. The goal of drug development is to quickly and safely determine the safety and efficacy of new drugs and the target population that will benefit most from new therapy. Within the past few years many new approaches have been developed to address this goal. This conference will focus on these new approaches; Adaptive Clinical Trial Designs, Bayesian analysis, and a new CR & D development model.
- Why and where adaptive trial designs should be used
- Adaptive designs as a portfolio management tool
- The use of Bayesian analysis in early decision making
- Case studies from trials which used flexible designs
- designs used
- operational planning and logistical issues associated with implementation
- lessons learned
- The perspective from government agencies
- Solutions to address issues raised by regulatory groups
Attendees will have a better understanding of the practical use of Adaptive Clinical Trial Designs and Bayesian analysis in portfolio management and clinical development programs.