Back to the program

Contributed Papers

Biomarkers and Endpoints: Validating Clinical Trial Success

Wed, Aug 6, 2:00 PM - 3:50 PM Room CC-102B Music City Center

Xin TongChair

Biopharmaceutical Section

7 Presentations

Causal framework for analyzing mediation effects of clinical biomarkers

2:05 PM - 2:20 PM

Co-authors: Jinesh Shah (CSL Behring), James Rogers (Metrum Research Group), Jinesh Shah (CSL Behring)

biomarkers causal inference mediation estimands

Evaluating Bias in the Anchor-Based Method for Finding the Minimal Clinically Important Difference

2:20 PM - 2:35 PM

Co-authors: Polyna Khudyakov (Sage Therapeutics), Gregory Hather, Polyna Khudyakov (Sage Therapeutics)

COA - clinical outcome assessment MCID - minimal clinically important difference Anchor-based method Bias Placebo effect Confounding

Evaluation Methods for T-Association of a Surrogate Endpoint

2:35 PM - 2:50 PM

Co-authors: Jo-Ying Hung, Chih-Yuan Hsu (Vanderbilt University Medical Center - CQS), Jo-Ying Hung, Pei-Fang Su (National Cheng Kung University), Yu Shyr (Vanderbilt University Medical Center)

Surrogate endpoint Bivariate normal maximum likelihood restricted maximum likelihood Bayesian

Investigating the performance of survival prediction using longitudinal biomarker

2:50 PM - 3:05 PM

Co-authors: Qing Xia (Amgen), Ting Zeng (Amgen), Qing Xia (Amgen), Jianqi Zhang (Amgen), Xun Jiang (Amgen), Mihaela Talpes (Amgen)

Longitudinal biomarker Survival prediction Joint Model Oncology clinical trials

Leveraging Real-World Evidence for Predictive Biomarker Discovery and CDx Development

3:05 PM - 3:20 PM

Co-authors: Szu-Yu Tang, Szu-Yu Tang

Real-World Evidence Biomarker Discovery Companion Diagnostics (CDx)Oncology

Mixed Model for Repeated Measures with Application to Cardiodynamic Electrocardiogram (ECG) Assessment

3:20 PM - 3:35 PM

Co-authors: Hongqi Xue (Clario), Hongqi Xue (Clario)

cardiodynamic ECG assessment concentration-QTc analysis by-time point analysis

Predictive biomarker graphical approach (PRIME) for Precision medicine

3:35 PM - 3:50 PM

Co-authors: Gina D'Angelo (AstraZeneca), Xiaowen Tian (AstraZeneca), Gina D'Angelo (AstraZeneca)

biomarker precision medicine patient enrichment prediction

↑