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Audio conference highlights

Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With FDA's Critical Path Initiative and the general urgent need for more efficient clinical development adaptive designs, these trials are receiving increased attention. There is a call to modernize drug development and utilize bioinformation to evaluate safety and effectiveness.

Adaptive designs have become popular tools in oncology research, helping to achieve more effective and affordable trials. This conference gives an overview of adaptive design thinking and issues, and explores their place in oncology trial design.

This audio conference covers:

• What is an adaptive design
• How adaptive designs for early and later phases differ
• What adaptive designs are old/new in oncology
• Issues to consider for early versus late phase adaptive designs in oncology
• Proposed general recommendations for incorporating adaptive designs

About the speaker:

John Constant, PhD, has over 25 years of experience in applied statistics and over 15 years in pharmaceutical research. He has served on data monitoring, steering and advisory committees, and as statistical advisor in oncology to various biotechnology and pharmaceutical companies. He has also served as a liaison to the FDA and EMEA on their behalf, having worked in that capacity with numerous heads at the agencies. Dr. Constant has also provided statistical consulting services to clients for oncology submissions in response to ODAC feedback, and has participated in (voted on, organized and written charters for) many DMCs.

Dr. Constant's oncology area experience includes design, analysis, reporting and regulatory agency representation on national and global trials and submissions in lung cancer, colon cancer, pancreatic cancer, breast cancer, ovarian cancer, prostate cancer, myeloma, lymphoma, melanoma, kidney cancer, liver cancer, bladder cancer, brain cancer and head and neck cancer.

Who should attend?

• VPs/Directors of Clinical Development
• VPs/Directors of Medical Affairs
• VPs/Directors of Clinical Operations
• VPs/Directors of Regulatory Affairs
• VPs/Directors of Safety and Risk Management

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.