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primary endpoint

70 papers and 9 presentations; 75 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG 2026 A Practical Approach to Multiple-Period CLINSITE Preparation Liyuan Huang,
Amanda Plaisted,
Sreedhar Bodepudi
source 6
PharmaSUG 2026 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. Shankar Srinivasan,
Yvonne Buttkewitz,
Regina Uttenreuther,
Baldeep Chani Talwar,
Manjari Dissanayake
source 12
PharmaSUG 2026 Oncology Solid Tumor Subcutaneous vs Intravenous Late-stage Study Analysis Sumanjali Mangalarapu,
Chuqing Chen,
Anilkumar Anksapur
source 11
PharmaSUG 2026 Trusting Your R Packages: A Practical, Risk-Based Approach to External Package Validation Radhika Etikala,
Valeria Duran
source 14
PHUSE US 2026 Advancing Precision Medicine and Regulatory Readiness: Data Harmonisation and Statistical Methods for Companion Diagnostics Bridging Studies Ummul Vara Qurratul Ain source
presentation source
10
PHUSE US 2026 Complex Trials, Simple Disclosures: Streamlined Transparency of Innovative Study Designs [presentation] Ritama Gupta Dempsey source 15
PHUSE US 2026 Mapping Minimal Residual Disease (MRD) Biomarker Data in Hematologic Malignancies: Clinical Significance and Data Standards in SDTM and ADaM Jyothi Nelakurthi source
presentation source
8
PHUSE US 2026 Prompting for Precision: Leveraging Agentic Workflows to Accelerate Clinical Trial Document Understanding Jaya Simha Inampudi source
presentation source
14
PHUSE APAC 2026 Crafting a recipe for success : Aligning Target Product Profiles and study design to ensure statistical significance translates to clinical relevance and role of DGF Soumitra Kar,
Novo Nordisk GBS
source
presentation source
9
PHUSE APAC 2026 The AI-Powered Scribe: An Agentic Framework for Automated CSR Authoring Allwyn Dsouza source
presentation source
7
PHUSE EU 2025 Interactive Insights: Leveraging R Shiny for Enhanced Data Visualisation in Clinical Trial Readouts [presentation] Carolyn Fisher,
Elisabeth Deutschmann
source 20
PHUSE EU 2025 Statistical Endpoints and Analysis in Diagnostic Imaging: The Matrix Has You and Your Data Srinivas Lanka,
James Sykes
source
presentation source
17
PharmaSUG 2025 A Novel ADEFF Design with Varying Baseline Type Selections Tingting Tian,
Chao Su,
Fan Wang,
Pengfei Zhu
source 6
PHUSE EU 2024 Failed Clinical Trials: How to Benefit From Negative Experience Anna Amosova source
presentation source
13
PHUSE EU 2024 Strategies to Improve Understanding of Estimands and Analysis Section of Statistical Analysis Plan Inderjeet Arora source
presentation source
8
PHUSE EU 2024 Transcriptomics - A Demanding Data Analysis that Expands the Limits of Regulated Clinical Data Handling Lea Yoshida Hildebrandt source
presentation source
6
WUSS 2024 An introduction to Quarto: A Versatile Open-Source Tool for Data Reporting and Visualization Joshua J. Cook,
Swann Arp Adams
source 18
PharmaSUG CN 2024 Best Overall Response (BOR) Confirmation in Oncology Clinical Trials: Insights from RECIST 1.1 Jihai Li source 15
PharmaSUG CN 2024 Implementing the treatment policy estimation for continuous variable with multiple imputation Andy Sun source 17
PharmaSUG 2024 An introduction to Quarto: A Versatile Open-Source Tool for Data Reporting and Visualization Joshua J. Cook source 18
PharmaSUG 2024 Implementation of composite estimands for responder analysis based on change from baseline in non-solid tumours Reshma Radhakrishnan source 11
PharmaSUG 2024 Quarto 1.4: Revolutionizing Open-source Dashboarding Capabilities Joshua J. Cook,
Kirk Paul Lafler
source 17
PHUSE US 2024 EOSS_MMRM V1.0: A Shiny Application for Estimand-Oriented Sample Size and Power Simulation Using MMRM Modelling Xiaoli Kong,
Jing Dai
source
presentation source
8
PHUSE US 2024 Ups, Downs, and FDA Crowns - Lessons Learned from BIMO Submission Adventures! [presentation] Sushant Thakare source 21
PHUSE EU 2023 Efficacy Endpoints in Adjuvant and Neo-Adjuvant Oncology Trials Yuliia (Piddubna) Cherednichenko,
Anna Amosova
source
presentation source
15
PHUSE EU 2023 Interaction with the FDA During and After a Type C Meeting, From the Perspective of a Statistical Programmer Dieter Hartz source
presentation source
5
PHUSE EU 2023 Optimizing Clinical Trial Design with Real-Time Sample Size Calculation and Enrollment Projection: A Shiny Dashboard Solution Dony Sabu source
presentation source
5
PharmaSUG 2023 Leverage and Enhance CDISC TAUGs to Build More Traceability for and Streamline Development of Efficacy ADaM in Oncology Studies Xiangchen (Bob) Cui source 29
PharmaSUG 2023 What-s the story in your subgroup analysis Lucy Dai source 6
PHUSE EU 2021 Does No Errors Equal High Quality? [presentation] Julie Solbjerg Appel,
Sanna Herrgård
source
video
23
PHUSE EU 2021 How Has the Immunotherapy Era Changed Response Criteria? [presentation] Anna Amosova source
video
30
PHUSE US 2021 Standing Room Only Presentation: DS06: CDISC Analysis Results Standard [presentation] Bess LeRoy source 25
PharmaSUG 2021 BIMO SAS Macros and Programming Tools Mi Young Kwon,
Rohit Kamath
source 12
PHUSE EU 2020 Define-XML for ADaM: Clinical Standards Toolkit vs. Pinnacle 21? [presentation] Frederikke Høyer source
video
16
PHUSE EU 2020 Let CDISC Be Roxane Debrus,
Silvia Faini
source
video
presentation source
8
PHUSE EU 2020 MI FOR MI, OR HOW TO HANDLE MISSING INFORMATION WITH MULTIPLE IMPUTATION Daria Shamaida source
video
presentation source
8
PHUSE EU 2020 Power BI in Clinical Data Exploration: Powerful Visuals that Answer Relevant Questions Roxane Debrus source
video
presentation source
11
PHUSE EU 2020 The TransCelerate Hackathon: Accelerating Development [presentation] Johannes Ulander source
video
26
PHUSE EU 2020 Using R Shiny to Increase the Efficiency of a Study Team [presentation] Emma Moore source
video
12
PharmaSUG 2020 Automating of Two Key Components in Analysis Data Reviewer's Guide Shunbing Zhao,
Jeff Xia
source 8
PHUSE US 2020 Data Science Project (Educating for the Future Working Group) Aldir Medeiros Filho,
Sascha Ahrweiler
source
presentation source
10
PHUSE US 2020 Design and Conduct of Clinical Trials: Past Present and Future. New Innovative Technology Methods George Obsekov source
presentation source
12
PHUSE US 2019 Misuse and Misapplication in Statistical Data Analysis - A Topic that Never Goes Out of Style Corinna Miede source
presentation source
12
PHUSE EU 2018 How to Write ADaM Specifications Like a Ninja Caroline Francis source
poster source
5
PHUSE US 2018 Drug-Induced Liver Injury (DILI) Classification Using FDA-Approved Drug Labeling and FAERS Data - FDA Qais Hatim source
presentation source
31
PHUSE US 2018 Modeling and Text Analysis to Empower FAERS Adverse Event Mitigation Qais Hatim,
Emily McRae
source
presentation source
24
PharmaSUG 2018 Programmer's Guide for OSI Deliverables - Creation of Site Level Summary Dataset and Automation of BIMO Listins Generation Charanjit Kahlon,
Kristie Kooken,
Bhavin Busa,
Dharmendra Tirumalasetti
source 10
PharmaSUG 2018 Sense and Censorability: Learn censoring techniques with ADTTE for your survival Shilpakala Vasudevan source 12
SGF 2018 Auto-populating Microsoft PowerPoint Presentations So You Don't Have To Kaitie Lawson source 17
PHUSE EU 2017 Futile or Not? An Interim Analysis Case Study Ingrid Franklin source
presentation source
9
PHUSE EU 2017 Power Calculation in a Multi-Stage Design, Following the Main Endpoint, A Binomial DIstribution Antonio Nieto,
Javier Gómez
source
presentation source
4
PharmaSUG 2017 Automated DSMB Presentation in SAS: Yeah, I'd Submit That! How to auto populate PowerPoint presentations so you don't have to Brett Jepson,
Kaitie Lawson
source 17
PharmaSUG 2017 ClinicalTrials.gov Results: an End of Study Deliverable That Should Be Considered at Study Startup Maya Barton,
Elizabeth Paynter
source 9
PharmaSUG 2016 Working with Composite Endpoints: Constructing Analysis Data Pushpa Saranadasa source 7
PHUSE EU 2014 Multiple Imputation: Better than Single Imputation in Pain Studies Ashik Chowdhury source
presentation source
12
PHUSE EU 2014 Submitting Summary Level Site Data: Overview, Implementation and Case Studies Robert F. Woolson,
Jeffrey M. Abolafia,
Ben Vaughn
source
presentation source
9
PharmaSUG CN 2014 Design and Construct Efficacy Analysis Datasets in Later Phase Oncology Study Huadan Li,
Changhong Shi
9
PharmaSUG 2014 Methodology for Non-Randomized Clinical Trials: Propensity Score Analysis Dan Conroy source 5
PharmaSUG 2014 Risk-Based Approach to Identifying and Selecting Clinical Sites for Sponsor's Preparation for FDA/EMA Inspection Xiangchen (Bob) Cui source 21
PHUSE EU 2013 Efficacy Endpoints in Oncology Angelo Tinazzi source 9
PHUSE EU 2013 Oncology Endpoints: An Unexpected Journey Waseem Jugon,
Mijanur Rahman
source 12
PharmaSUG 2013 Experiences in Preparing Summary Level Clinical Site Data within NDA's Submission for FDA's Inspection Planning Xiangchen (Bob) Cui source 19
PHUSE EU 2012 East6: Software for Designing, Simulating and Monitoring Group Sequential Trials Hrishikesh Kulkarni,
Sheetal Solanki
source
presentation source
12
SGF 2012 Use of Cutoff and SAS Code Nodes in SAS Enterprise Miner to Determine Appropriate Probability Cutoff Point for Decision Making with Binary Target Models Yogen Shah source 6
MWSUG 2011 Objective tumor response and RECIST criteria in cancer clinical trials Jian Yu 6
SGF 2011 Randomizing Small Strata Groups: Balancing Baseline Population Measures While Staying True to a Chosen Allocation Strategy, an Alternative to PROC SURVEYSELECT Gregg M. Oginz source 12
SGF 2009 Fitting Cox Model Using PROC PHREG and Beyond in SAS Lea Liu,
Sandy A. Forman,
Bruce A. Barton
source 10
PharmaSUG 2006 Sample Size Calculation and Timeline Estimate for Progression-Free Survival Chung-Kuei Chang 10
PharmaSUG 2005 Power Analysis and Sample Size Estimation using Bootstrap Xiaomei Peng,
Guangbin Peng,
Celedon Gonzales
7
PharmaSUG 2005 Some Statistical Programming Considerations for e-Submission Hang Pang 6
PharmaSUG 2004 PROC POWER: V9.1 Deborah J. Bauer 6
SUGI 2004 PROC POWER in SAS 9.1 Deborah J. Bauer,
Russell M. Lavery
source 7
NESUG 2001 Power and Sample Size Determination for Linear Models John M. Castelloe 13
SESUG 2001 Power and Sample Size Determination for Linear Models John M. Castelloe source 13
SCSUG 2001 Power and Sample Size Determination for Linear Models John M. Castelloe,
Ralph G. O'Brien
13
PharmaSUG 2001 Power and Sample Size Determination for Linear Models John M. Castelloe 14
PharmaSUG 2001 Using SAS Version 8.1 Output Delivery System to Automate Two Sample Test Selection 4
SUGI 2001 Power and Sample Size Determination for Linear Models John M. Castelloe,
Ralph G. O'Brien
source 13
PharmaSUG 2000 Using SAS for the Statistical Analysis of a Bivariate Primary Endpoint in a Clinical Trial of Chronic Fatigue Syndrome (CFS) Naum M. Khutoryansky,
David R. Strayer,
William A. Carter
3

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