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 the regulatory Critical Path Initiatives and the general urgent need for more efficient clinical development adaptive and other patient – efficient designs are continuing to receive increasing attention and FDA has recently published their long-awaited Guidance on adaptive designs. This session will overview recent developments in oncology design thinking and issues related to adaptive, single arm and Phase I/II designs as used in practice in oncology trials.

This audio conference covers:

• Overview and recent developments in adaptive and small-n oncology designs
• Highlights from recent FDA guidance on Adaptive Designs
• Common Ph I/II single arm, sample size re-estimation and randomized efficacy screening and tumor screening Ph II solid tumor designs for minimizing n seen in practice
• Recent views on use of concurrent vs historical control and single arm designs for supportive and pivotal trials in regulatory interactions with FDA and SAWP
• Blinding and DMC issues on single arm and open-label oncology 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 Regulatory Affairs
• VPs/Directors of Clinical Operations
• VPs/Directors of Medical Affairs
• CSO
• CMO