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Contributed Papers

Applications in Clinical Trial Design

Mon, Aug 7, 2:00 PM

Zhaowei HuaChair

Biopharmaceutical Section

7 Presentations

Combination MCP-Mod for two-drug combination dose-ranging studies

2:05 PM - 2:20 PM

Co-authors: Yifan Zhou (Pfizer), Sandeep Menon (Pfizer), Ling Wang (Alkermes)

Design and Simulation of Pragmatic Clinical Trial (PCT) for Breast Cancer Patients using NCDB

2:20 PM - 2:35 PM

Co-authors: Shesh Rai (University of Cincinnati)

Enrichment Design and the Modified Completer Population in Human Abuse Potential Studies

2:35 PM - 2:50 PM

Ling Chen (FDA)

How to incorporate regional differences using hierarchical models in multiregional clinical trial

2:50 PM - 3:05 PM

Co-authors: Seung-Ho Kang (Yonsei University)

Intra-individual dose escalation and dose-response analysis for efficient proof-of-concept study

3:05 PM - 3:20 PM

Timothy Clough (Novartis Pharmaceuticals)

Co-authors: Bjorn Bornkamp (Novartis Pharma AG), Martin Fink (Novartis Pharmaceuticals), Alison Margolskee (Novartis Pharmaceuticals), Mike Mendelson (Novartis Pharmaceuticals), Ramprasad Ramakrishna (Novartis Pharmaceuticals), Brian Smith

Optimal enrollment policy for late-stage group sequential trials with learning drug's efficacy

3:20 PM - 3:35 PM

Hong Li (University of California, Davis)

Co-authors: Zhili Tian (University of Houston), Gordon Hazen (Northwestern University)

The statistical method of assessing bioequivalence of topical dermatological products with IVPT data

3:35 PM - 3:50 PM

Elena Rantou (FDA/CDER)

Co-authors: Jeongsook Kim (FDA/CDER), Nam Hee Choi (FDA), Sungwoo Choi (FDA), Daeyoung Lim

Session participants

Elena Polverejan (Johnson & Johnson-Janssen R&D)

Participant

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