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General Session I: The Agency's Critical Path Initiative and the Statistician's Role in Evaluating the Safety of New Drug Products

No presentations received

General Session II: Flexible Design: A Debate

Presentation A - Bayesian Adaptive Design & Interim Analysis - Donald Berry

General Session III: Non-inferiority Trials: What Are Our Experiences?

Presentation B - Non-Inferiority in Conformity Active Control Clinical Trials: Concepts and Statistical Methods - Gary Koch

General Session IV: Quantifying the Ratio of Risk and Benefit - no presentations received

Presentation B - Superior Safety in Noninferiority Trials- David R. Bristol

Parallel Sessions I - Gate-keeping Strategy, Co-primary Endpoints and Secondary Endpoints

	Presentation A - Multiplicity Adjustment for Clinical Trials with Two Doses of an Active Treatment and Multiple Primary and Secondary Endpoints - Hui Quan
	Presentation B - Gatekeeping Testing Strategies in Clinical Trials - Alex Dmitrienko
	Presentation C - On Some Statistical Considerations in Testing for Multiple Endpoints in Clinical Trials - Mohammad Huque
	Presentation D - Discussion for 'Gate-Keeping Strategy Session" - Gary Koch

Parallel Sessions II - Evolving Data Standards: Implications for Statistical Analysis and Review

	Presentation A - Evolving Data Standards: Implications for Statistical Analysis and Review - Stephen Ruberg
	Presentation B - Beyond the CDISC SDTM V3.1 Model: Statistical & Programming Considerations - William Qubeck

Parallel Sessions III - Controls

	Presentation A - Controls from Principal Stratification and an example from the Baltimore's Needle Exchange Program - Constantine Frangakis
	Presentation B - Using an External Control to Evaluate the Effectiveness of Posaconazole for Refactory Invasive Fungal Infections - Kenneth Koury and Jagadish P. Gogate
	Presentation C - The Application of Propensity Score Analysis to Non-randomized Medical Device Clinical Studies: A Regulatory Perspective - Lilly Yue

Parallel Sessions IV - Missing Data: Are We Dealing With the Real Problem?

	Presentation A - Comparing LOCF with mixed-model analysis (MMRM) for longitudinal trials with missing data - Peter Lane
	Presentation B - Sensitivity Analysis for Randomized Trials with Missing Data - Daniel Scharfstein
	Presentation C - Management of Missing Data in Clinical Trials from a Regulatory Perspective - James Hung

Parallel Sessions V - Advisory Committees and Regulatory Review

No presentations received

Parallel Sessions VI - Surrogate Markers in Drug Development

	Presentation A - Surrogate Markers and its Role in the Drug Development Process - Aloka Chakravarty
	Presentation B - Statistical Challenges in the Validation of Surrogate Endpoints - Marc Buyse
	Presentation C - Statistical Issues in the Validation of Surrogate Endpoints - Stuart Baker
	Presentation D - Promotion and Marketing of Prescription Drugs - Lesley R. Frank
	Presentation E - A Practical Approach to Accelerating the Clinical Development Process - Jerald S. Schindler

Parallel Sessions VII - Accelerating Drug Development Using Novel Experimental Designs and Analyses

Presentation A - A Practical Approach to Accelerating the Clinical Development Process - Jerald S. Schindler

Parallel Sessions VIII - Issues in Phase IV Post Marketing and Production

No presentations received

Parallel Sessions IX - FDA/Industry Symposium on Clinical Pharmacogenomics/Proteomics

No presentations received