Emerging Trends in Regulatory Biostatistics - What Might Be Their Impact ?

Bob O'Neill

Emerging Trends in Regulatory Biostatistics - What Might be Their Impact ?

During the last two years, several emerging trends and topics have spotlighted biostatistical issues as central to modern drug development and regulation. The talk will highlight these topics and outline how the changing product development and public health environment will likely impact the practice of biostatistics in the biopharmaceutical field. FDA is facing an unprecedented increase in challenging problems and expectations that will call on biostatistics for contributions and leadership. Among the topics that are receiving the most attention are the interest in adaptive study designs, non-inferiority clinical trials, dealing with multiplicity in study endpoints and subgroups, the planning for and analysis of missing data in clinical trials, quantifying safety and benefit and risk, and the impact of personalized medicine associated with genomic advances. These topics will be explored with respect to an outlook on the next five years.