Back to the program

Contributed Papers

Adaptive & Seamless Clinical Trial Designs

Thu, Aug 6, 8:30 AM - 10:20 AM Room CC-206B Thomas M. Menino Convention & Exhibition Center

Hongwei WangChair

Biopharmaceutical Section

6 Presentations

A cautionary note on seamless phase II/III adaptive design with treatment selection in Phase II

8:35 AM - 8:50 AM

David Li (Eisai)

Co-authors: Shobha Dhadda

Seamless Phase II/III design Dose‑finding and dose selection Multiplicity and alpha control Biomarker‑driven development

Adaptive seamless phase II/III randomization test with binary short-term treatment selection

8:50 AM - 9:05 AM

Funato Sato (Tokyo Metropolitan Hospital Organization)

Co-authors: Kohei Uemura, Junki Mizusawa (JCOG Data Center), Yutaka Matsuyama (University of Tokyo), Yoshihiko Morikawa (Tokyo Metropolitan Hospital Organization)

Adaptive seamless phase Ⅱ/Ⅲ design short-term outcome response rate overall survival correlation randomization test

An Adaptive Two-Stage Bioequivalence Design with Formulation Selection and Sample Size Re-estimation

9:05 AM - 9:20 AM

adaptive clinical trial sample size re-estimation bioequivalence

Interactive Multicriteria Optimization for Clinical Trial Designs

9:20 AM - 9:35 AM

Nitin Patel (Cytel)

Co-authors: Jaydeep Bhattacharyya (Cytel, Inc), James Bolognese (Cytel)

Clinical Trial Design Pareto Optimization Pareto Contour maps Multiple objectives Design Trade-offs Probability of Success

Phaseless Clinical Trials in Gene Therapy and Xenotransplantation Studies

9:35 AM - 9:50 AM

Yen Chang (The University of North Carolina at Chapel Hill)

Co-authors: Yen Chang (The University of North Carolina at Chapel Hill), Leigh Peterson (United Therapeutics Corp.), Kristina DeSmet (United Therapeutics Corp.), Margaret R. Sketch (United Therapeutics Corp.), Marc Lorber (SVP and CMO, Product Development), Victoria Lacasse (United Therapeutics Corp.), Jayme Locke (United Therapeutics Corp.), Chunqin Deng (United Therapeutics Corp.)

Phaseless clinical trial Seamless clinical trial Expansion cohorts gene therapy xenotransplantation rare disease

Integrating Bayesian and promising zone approaches in a Phase 3 rare-disease study

9:50 AM - 10:05 AM

Sergei Leonov (CSL Behring)

Co-authors: Vaibhav Mahajan (Ultragenyx), Aparna Raychaudhuri (Independent Consultant)

Adaptive design Bayesian design Interim analysis Promising zone approach Conditional power

↑