Bethesda North Marriott Hotel & Conference Center, Bethesda, MD USA
Tutorials: April 10 • Workshop: April 11-13, 2011
An Open Forum to Discuss Important Statistical Issues Associated with the Development and Review of Therapeutic Drugs and Biologics. Don’t miss your annual opportunity to learn about and discuss the current and emerging statistical methodologies and quantitative approaches used to develop evidence of the effi cacy and safety of new drug and biologic therapeutic products. Now in its fi fth year, this year’s meeting will continue the dialogue in an open, public forum, regarding FDA guidance development and regulatory science initiatives — emphasizing the statistical challenges associated with innovative approaches to the design and analysis of clinical trials data. In recent years, thought leaders from government agencies, industry, and academia have discussed: • Meta-analysis in the Evaluation of Cardiovascular Risk • FDA Guidance Documents on Non-inferiority and Adaptive Designs • Modeling and Simulation for Quantitative Decision Making • Challenges in Developing Tailored Therapies by Subgroup Identifi cation • Using CDISC/ADaM to Create Analysis-ready Datasets • Collaborative Environments for Statistical Methodology Development • Comparative Eff ectiveness Research • Biomarker Development and Assessment • Previous Year’s Statistical and Regulatory Highlights Event #11008
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