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clinical endpoint

55 papers and 9 presentations; 62 titles.

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Conference × Year × Title × Authors Extras Pages
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 Bridging Analysis and Strategy: The Transformative Role of Statistical Analysts in Drug Development Lingsong Yun source
presentation source
17
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 APAC 2026 Beyond Toxicity : Accelerating Dose -Finding with Pharmacokinetic -Driven Bayesian Design PKBOIN-12 Anetta Mary Xavier source
presentation source
13
PHUSE APAC 2026 Future-Focused Real-World Data Use Strategies: Resilience and Innovation at Chugai Wataru Ohtsuka,
Nauta Yamanaka
source
presentation source
8
PHUSE EU 2025 Showcasing a Shiny Tool for Evaluating Biomarkers for Derisking Clinical Trials Stefan Thoma source
presentation source
9
PharmaSUG 2025 Avoiding the Ouch: Mastering Time to Pain Progression Analysis Kavitha Boinapally,
Sai Krishna Pavan Nakirikanti,
Hank Dennis,
Yang Wang
source 9
PharmaSUG 2025 Guidance from the FDA authored "Submitting Patient-Reported Outcome Data in Cancer Clinical Trials" and recommendations for their implementation in study CDISC COA data. Charity Quick source 14
PharmaSUG 2025 Methodology for AI-driven Outcome Prediction for Patients with Atrial Fibrillation After Transcatheter Aortic Valve Implantation (TAVI) Felix Just,
Krishna Padmanabhan,
Parth Jinger,
Amanda Borrow,
Rüdiger Smolnik,
Eva-Maria Fronk,
Neelam Yadav,
Sergei Krivtcov,
Stas Zakharkin,
Martin Unverdorben,
Asmir Vodencarevic
source 6
PHUSE EU 2024 Clinical Disease Endpoint Flag Implementation for Vaccine Studies Charumathy Sreeraman source
presentation source
7
PHUSE EU 2024 Guidance Beyond the SDTM Implementation Guide Kristin Kelly source
presentation source
10
PharmaSUG CN 2024 Implementing Statistical Methods in Companion Diagnostic: A Case Study in NSCLC Danxia Hu,
Mandy Gao,
Jianyong Tong
source 10
PharmaSUG 2024 Guidance Beyond the SDTM Implementation Guide Kristin Kelly,
Michael Beers
source 11
PharmaSUG 2024 Guideline for Creating Unique Subject Identifier in Pooled studies for SDTM Vibhavari Honrao source 5
PharmaSUG 2024 Oncology ADaM Datasets Creation Using R Programming: A Comprehensive Approach Ishwar Chouhan source 29
PHUSE US 2024 Guidance Beyond the SDTM Implementation Guide Michael Beers,
Blue Bell
source
presentation source
10
PHUSE EU 2023 Efficacy Endpoints in Adjuvant and Neo-Adjuvant Oncology Trials Yuliia (Piddubna) Cherednichenko,
Anna Amosova
source
presentation source
15
PHUSE EU 2023 Real-World Outcomes and Biomarker Testing in Cancer Patients: Exploration of a Novel Genetic Database from Routine Clinical Practice in England Alexandrina Lambova,
Fiona Ingleby
source
presentation source
5
PharmaSUG 2023 Comparison of My Experience Between an Independent Consultant and an Employee Kriss Harris source 11
PharmaSUG 2023 FDA's Study Data Policy Framework and How CDISC Properties Are Evaluated for Inclusion Helena Sviglin source 20
PHUSE EU 2022 From 'Being Alive' to 'Living': Why Does PRO Data Matter? [poster] Nimisha Joshi,
Rachel Thackray
source 1
PharmaSUG 2022 Begin with the End in Mind: eCOA data from collection to analysis Franklin E. Menius,
Monali Khanna,
Vincent Allibone
source 7
PharmaSUG 2022 Finding Accord: Developing an eCOA Data Transfer Specification (DTS) All Can Agree On Franklin E. Menius,
Monali Khanna,
Vincent Allibone
source 12
PHUSE US 2022 The Decentralized Trials Data Problem: Foundations for the Future of Clinical Trials [presentation] Raj Indupuri source
video
11
PHUSE EU 2021 Data Engineering - An Emerging Skill for Today's Statistical Programmers [presentation] Axel Muehlig,
Sangeeta Bhattacharya
source
video
18
PHUSE EU 2021 Incorporating Novel Real-world Evidence Across the Drug Development Continuum: Leveraging the Value of Digital Social Media [presentation] Nardin Farid,
Stephen Doogan
source
video
24
PHUSE US 2021 COVID-19 Outbreak Visualization Using a Clinical Data Science Platform [presentation] Iryna Kotenko,
Sergey Glushakov
source
video
15
PHUSE US 2021 The Case for Pandemic-disrupted Studies and Challenges Implementing CDISC and FDA COVID-19 Guidelines for NDA Submissions [presentation] Vidya Muthukumar source 44
PHUSE EU 2020 Implementing FAIR in OHDSI: Challenges and Opportunities in EHDEN [presentation] Tess Korthout source
video
23
PHUSE EU 2020 Rare Diseases - The Challenges of Programming Novel eCOA Endpoints [presentation] Luke Thompson source
video
24
PHUSE EU 2020 Template-based Graph Generation in Python and its Maintenance in Git [presentation] Pournima Prabhakaran source
video
21
PHUSE EU 2020 Understanding the Spread of COVID-19 in the United States Using Topology and Machine Learning for Time Series Iryna Kotenko,
Kostiantyn Drach
source
video
presentation source
32
SGF 2020 Transdermal Medicine - Challenges and Solutions with SAS Marina Komaroff source 14
PHUSE US 2020 Integration of Biomarkers Data in Clinical Trials Prakash Dev source
presentation source
5
PHUSE US 2020 Real-time Oncology Review - Applicant Experience Annie Varghese source
presentation source
5
PHUSE EU 2019 Sub-population Detection Using Graph-based Machine Learning Sergey Glushakov,
Kostiantyn Drach
source 28
PharmaSUG 2019 This Paper focuses on CDISC Questionnaires, Ratings and Scales (QRS) supplements and types of FDA Clinical Outcome Assessments Shrishaila Patil source 10
PHUSE US 2019 Creating the Virologic Response ADaM Dataset Manjusha Alapati source
presentation source
7
PHUSE EU 2018 Handling Missing Data in Clinical Trials Using Topological Data Analysis Sergey Glushakov,
Andrey Rekalo
source
presentation source
10
WUSS 2018 Combined Predictor Selection for Multiple Clinical Outcomes Using PHREG L. Grisell Diaz-Ramirez,
Siqi Gan,
Sei J. Lee,
Alexander Smith,
John Boscardin
source 14
PHUSE US 2018 Going Pro with PROs: Implementation and Analysis of Patient Reported Outcomes Shilpakala Vasudevan source
presentation source
12
PHUSE US 2018 Modeling and Text Analysis to Empower FAERS Adverse Event Mitigation Qais Hatim,
Emily McRae
source
presentation source
24
PharmaSUG 2018 Animated Multi-dimensional Scatter Plot Visualization for Longitudinal Clinical Trial Data Reporting Tao Shu,
Jianfei Jiang
source 7
PHUSE EU 2017 A Target Approach to Medical and Safety Reviews Erik Doffagne source
presentation source
2
PHUSE EU 2017 Topology-based Clinical Data Mining: Identifying Hidden Patterns in Clinical Datasets Sergey Glushakov source
presentation source
18
PharmaSUG 2017 A Practical Guide to Healthcare Data: Tips, Traps, and Techniques Gregory S. Barnes Nelson source 20
PharmaSUG 2017 Topology-based Clinical Data Mining for Discovery of Hidden Patterns in Multidimensional Data Sergey Glushakov,
Iryna Kotenko,
Andrey Rekalo
source 20
SGF 2017 A Practical Guide to Healthcare Data: Tips, Traps, and Techniques Gregory S. Barnes Nelson source 20
SGF 2017 What Is Needed for True Population Health Intelligence? Laurie Rose,
Dan Stevens
source 8
MWSUG 2016 The Power of Cumulative Distribution Function (CDF) Plot in Assessing Clinical Outcomes Min Chen,
Patricia Kultgen
6
PHUSE EU 2014 Analysis of Self-Reported Health Outcomes Data from Web-Based Media Sources Mark Wolff,
Kenneth Lopiano
source
presentation source
2
PharmaSUG 2014 Creating a Career GPS to Enhance Your Opportunities: Ten Steps to Improve Your Value by Strengthening Your Planning Bill Donovan,
Shridhar Patel
source 3
PHUSE EU 2013 Oncology Endpoints: An Unexpected Journey Waseem Jugon,
Mijanur Rahman
source 12
PharmaSUG 2012 Using SAS to Calculate Noncompartmental Urine Parameters Vanessa Rubano,
Modesta Wiersema
source 8
SGF 2012 Cluster Mapping of Medicare Severity Diagnosis-Related Groups for ICD-10 Conversions Keith A. Jones source 11
PharmaSUG 2011 Cost-Effectiveness Of Primary PCI At Hospitals Without Onsite CaABG Pedro Ramos source 21
SGF 2011 Modeling Percentage Outcomes: The %Beta_Regression Macro Christopher J. Swearingen,
Maria S. Melguizo,
Zoran Bursac
source 12
SGF 2010 Pleasing the Client: Creating Custom Reports with SAS ODS LAYOUT and the REPORT Procedure Barbara B. Okerson source 9
SESUG 2009 Pleasing the Client: Creating Custom Reports with SAS ODS Layout and Proc Report Barbara B. Okerson source 9
MWSUG 2008 A Multivariate Ranking Procedure to Assess Treatment Effects Alan Y Chiang,
Grace Li,
Ying Ding,
Ming-Dauh Wang
7
PharmaSUG 2003 Use of Text Miner to Automatically Abstract Patient Information from the Pharmacy Order Database Patricia B. Cerrito,
Antonio Badia,
John C. Cerrito,
James A. Cox
6
SESUG 2000 SAS IML Code To Calculate an Upper Confidence Limit for Multivariate Statistical Distance Margaret Connolly,
Wyeth Lederle Vaccines,
Pearl River
source 6
SUGI 1998 Developing Risk-Adjustment Models Using SAS Software: An Application in Home Health Care Ding Alonzo,
Albert Alva
source 4
WUSS 1996 SAS PROC MIXED to Fit Growth Curve Models: Application to a Longitudinal Group Randomization Study Biao Wm. Lu,
Sandra Wilson,
David Latini,
David Dayton
source 6

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