PharmaSUG2026paper·US·Real-World Data (RWD) and Real-World Evidence (RWE)
PSMATCH: Propensity Score Matching of Clinical Trial Data with External Control Arms RW-367
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Conference Papers
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PharmaSUG2026paper·US·Real-World Data (RWD) and Real-World Evidence (RWE)
Contrast Effects in Curated Observational Data RW-379
PharmaSUG2026paper·US·Real-World Data (RWD) and Real-World Evidence (RWE)
Assessing Quality of Real-World Data Sources RW-384
PharmaSUG2026paper·US·Real-World Data (RWD) and Real-World Evidence (RWE)
Biostatistical Foundations 201: Privacy Preserving Patient Linkage Across Real World Data Sources RW-429
PharmaSUG2026paper·US·Real-World Data (RWD) and Real-World Evidence (RWE)
Operationalizing Real World Data for External Control Arms: An End to End Framework for Rare Disease and Oncology Trials RW-435
PharmaSUG2026paper·China·Statistics and Analytics (SA)
Design and Analysis of a Multi-Frequency PRO Collection Strategy in a Clinical Trial SA-133 Shanghai
PharmaSUG2026paper·China·Statistics and Analytics (SA)
ESTICID: a SAS macro for Estimating Clinically Important Difference using an anchor-based approach in longitudinal data SA-138 Shanghai
PharmaSUG2026paper·China·Statistics and Analytics (SA)
A Traceable and Reproducible Framework for Oncology Efficacy Data Review Using IMWG Criteria: A BCMA Case Study SA-168 Shanghai
PharmaSUG2026paper·China·Statistics and Analytics (SA)
Chronic Graft-versus-Host Disease (cGVHD) efficacy criteria exploration and implementation challenges – based on a first line phase 3 case study SA-176 Shanghai
PharmaSUG2026paper·China·Statistics and Analytics (SA)
Handling Missing Data in Analgesia Clinical Trials and Corresponding SAS Implementation SA-191 Shanghai
PharmaSUG2026paper·US·Study Data Integration & Analysis
Insights and Experience Sharing with Patient-Reported Outcome Data Analysis in FDA’s Submission SI-109
PharmaSUG2026paper·US·Study Data Integration & Analysis
A Statistical Programmer’s Guide to Tipping Point Analysis in SAS SI-227
PharmaSUG2026paper·US·Study Data Integration & Analysis
From Data to Dossier: Lessons from Cross-Company Regulatory Submissions SI-293
PharmaSUG2026paper·US·Study Data Integration & Analysis
An Approach for Generating Tumor Biopsy Datasets for Drug Development SI-306
PharmaSUG2026paper·US·Study Data Integration & Analysis
Algorithms to align the distribution of follow-up across independently collected cohorts when comparing time to event endpoints using conventional Kaplan Meier and Cox regression methods. SI-348
PharmaSUG2026paper·US·Study Data Integration & Analysis
From Chaos to Consistency: Standardizing External Clinical Data with Excel Power Query SI-373
PharmaSUG2026paper·US·Study Data Integration & Analysis
Harmonizing History: A Framework for Deriving Line of Therapy in Complex Integrated Summaries. SI-414
PharmaSUG2026paper·US·Submission Standards for Global Health Authorities
Structure for Success: Delivering a Complex, Accelerated NDA with Evolving Scope SS-193
PharmaSUG2026paper·US·Submission Standards for Global Health Authorities
Lessons to Guardrails: Operationalizing Early Checks for FDA Submission Readiness SS-209
PharmaSUG2026paper·US·Submission Standards for Global Health Authorities
Efficiency in Action: Automating Bookmarking for CRFs and Other Regulatory Submission Documents SS-243