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Professional & Student Poster Presentations
Student
- M-01: Efficacy and Safety of Tyrosine-Kinase Inhibitors as First-Line Treatment in Advanced NSCLC Patients: A Network Meta-Analysis
- M-02: Impact of Patient Support Programs on the Performance of Adverse Drug Event (ADE) Signal Detection
- M-03: Systematic Evaluation of Randomized Controlled Trials on Nutraceuticals Containing Chinese Medicines for Diabetes Management
- M-04: A Review on Methodological Quality of Traditional Chinese Medicine’s Clinical Trials’ Design in 2016
- M-06: Evaluation of the Effect of Aegle Marmelos in a Murine Model of Trinitrobenzene Sulfonic acid (TNBS) Induced Coliti
- M-07: Evaluation of the Anti-Anxiety Effect of Minocycline on Resident Intruder Model of PTSD in Golden Syrian Hamsters
- M-08: Improvement of Intestinal Dysbiosis With Exogenous Prebiotic Metabolites Reduces Intestinal Bowel Inflammation
- M-09: Disseminating Regulatory Self-Study Tools: A Study of the Efficacy and Promulgation of USC’s Clinical Trial Quality Training
- M-10: Study on Reducing Errors in Data Input to a Case Report Form
- M-11: Barriers and Facilitators to Using Current and Revised Australian Product Information: Perceptions of Healthcare Professionals
- M-12: Pharmacogenomics in Drug Labeling and Guidelines: An International Perspective
- M-13: Orphan Drug Demand Analysis in China - Empirical Forecasting Study of National Market from 2019 to 2028
- M-14: Biopharmaceutical Innovation: An Evaluation of Clinical Phase and Market Entry Period in Novel Drug Products
- M-15: Global Supply Chain Issues Affecting Biopharmaceutical Manufacturers: An Analysis of FDA Warning Letters from 2013-2018
- M-16: Impact of Different Randomization Techniques on The Statistical Efficiency in Clinical Trials
- M-17: Sample Size Planning in Bioequivalence Trials: A Systematic Review of Methodology
- M-18: Generic Medications: A Comparison on Drug Prices and a Cross Sectional Survey on Knowledge, Perception and Use
- M-19: An Evaluation of Comments to the CMS Proposed Drug Price Transparency in Direct-to-Consumer Television Advertising Rule
Professional
- T-01: Use of Adverse Event Data to Develop an Artificial Intelligence Application for Assessing Seriousness
- T-02: Using Innovative Automation to Author Development Safety Update Reports and Enhance Cost-Effectiveness
- T-03: Development of an AI Approach for Identifying Adverse Events
- T-04: Effect of Drug Safety Communications on Adverse Event Reporting in Multiple Sclerosis DMTs using the FAERS Database 2000-2017
- T-07: FDA Developed Tool for Adverse Event Data Signal Detection in Clinical Safety Analysis
- T-09: Structure and Target Based Statistical Tools for Safety Analysis
- T-10: A Seamless Phase 2/3 Adaptive Design for Clinical Trials with a Continuous Endpoint in Asia
- T-11: Subject Training is Needed For Key Terminology in Gastrointestinal Clinical Trials
- T-12: Design and Analysis of Biosimilarity Based on Interval Estimations
- T-13: Academia’s Challenges for Implementing an Investigator-initiated Clinical Trial Aimed at Developing A New Biological Drug
- T-14: Quality Management Using Six Sigma Tools For Clinical Research Sites
- T-15: Natural History Studies: An Assessment of Current Trends in Design and Disease Research
- T-16: Generating Synthetic Control Patients Using Machine Learning for Alzheimer’s Disease Clinical Trials
- T-17: Streamlining Clinical Trials and Patient Experience Using Blockchain and Data Science Technologies
- T-18: Effectiveness of Patient Portals in Clinical Trial Recruitment
- T-19: Metadata Framework for Sharing and Developing Code Repository for Standard Analyses
- T-20: Understanding Heterogeneity in Rheumatoid Arthritis Disease Progression by Using Word Embedding: An Electronic Health Record
- T-21: Characteristics of Expanded Access Programs Inclusive of Children in the United States
- T-22: Writing a Platform Master Protocol Using the Common Protocol Template
- T-23: Adherence to Standardized INCI Labeling Practices in Twenty One Natural or Organic Global Consumer Baby Products
- T-24: Should I Stay or Should I go? A Comparison of Primary and Secondary Research on Clinical Trial Retention
- T-25: ClinLine.ru: The New Integrated Infomedia Russian Platform for all Parties Involved in Clinical Trials
- T-26: Demystifying the Patient’s Experience: Use of Patient Journey Studies to Gather Valuable Qualitative Insight into the Patient
- T-27: Measuring the Patient Experience: Learnings from Real World Implementation to Improve Data Collection and Patient Engagement
- T-28: The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety
- T-29: Python Optimization Tools for Remote Server Work
- T-30: An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for GCP Violations
- T-31: Characterizing the Clinical Impact of Immunogenicity in Prescription Drug Labeling
- T-32: Baseline Adjustment in Concentration-QTc Modeling: Impact on Assay Sensitivity
- T-33: Compliance with FDA’s Postmarketing Adverse Drug Experience Laws and Regulations
- T-34: Otsuka’s Experience on eSubmission of Promotional Labeling and Advertising Materials via the eCTD FDA Gateway
- T-35: Considerations in Using Biomarkers as Efficacy Endpoints: The Review of Clinical Trials of Orphan Drugs Approved in Japan
- T-36: The South African Regulatory Environment: Challenges and Opportunities for a Reformed Regulatory Review Process
- T-37: Regulatory Review Reliance Models: What are the Barriers and Enablers to the Successful use of These Models for Medicines?
- T-38: Agencies Strategies to Enhance the Review Efficiency of IND for Human Cell Therapy Products in Taiwan
- T-39: Use of Social Media in Clinical Trials: A Survey of IRB Chairs
- T-40: Comprehensive QOS and Established Conditions: Creating a Path for Flexible Regulatory Approaches to Post Approval CMC Changes
- T-41: Using Causal Inference Modelling to Predict Unbiased Treatment Response for Managed Care Organizations and Drug Manufacturers
- T-42: Sample Size Re-Estimation in Action: Design Consideration, Charter Development, and Implementation of Analyses in a Trial with Adaptive Components
- T-43: Combining Tabular Data with Visual Display to Enhance Interpretation of Clinical Trial Data
- T-44: A Real World Budget Impact Analysis of Apremilast or Biologic Treatment in Biologic-Naive Patients With Psoriasis
- T-45: A Decision Analytic Benefit-Risk Assessment Framework to Support Portfolio Prioritization Decisions
- T-46: An Analysis of Healthcare Plan CAR T Cell Coverage Criteria for Medicaid Beneficiaries
- T-47: Assessment of the Quality of Pharmacoeconomic Reports in Taiwan
- W-01: A Real World Investigation of Finasteride and the Risk of Prostate Cancer
- W-02: Improving Cost-Effectiveness by Automating the Aggregate Report Scheduling & Distribution
- W-03: Development and Operationalization of a Method for Determining Adverse Drug Reactions from a Clinical Study Safety Data Set
- W-04: Reducing the Cost of Systematic Risk Assessments of Medical Products by Using a Modular Learning Risk Repository System
- W-05: Design Thinking in Pharmacovigilance
- W-06: Healthcare Professionals’ Knowledge and Adherence to the National Guidelines for Management of Pediatric Asthma
- W-07: A General Framework for Utilizing Real World Data with Clinical Trials
- W-08: Using a Continuous Learning Risk Repository System to Drive Efficiencies in Identification of Clinical Protocol Risk Patterns
- W-10: The Rise of Electronic Patient-Recorded Outcomes in Oncology (ePRO)
- W-11: Advantages of a Peer Mentoring Program in Clinical Operations
- W-12: Relationship Between Efficacy and Discontinuation Rates in Clinical Trials of Moderate to Severe Crohn’s Disease
- W-13: Best Practices for the Electronic Migration and Implementation of Clinician-Reported Outcomes Assessments in Clinical Trials
- W-14: Common Symptom Terminology is Frequently Misunderstood
- W-16: Patient Understanding of Rescue Medication: Value of Patient Training on Reporting Rescue Medication Use
- W-17: Subject Training Substantially Improves Understanding of Key Terminology in Gastrointestinal Clinical Trials
- W-18: Putting the Patient at the Center of Medical Information – A Patient-centric Standard Response Letter Initiative
- W-19: Defining Excellence and Best Practices in Medical Information for AMCP Dossier Creation and Compendia Review
- W-20: Building Patient Trust: Our Journey to "Radical" Transparency in Compassionate Use
- W-21: Meaningful Patient Engagement: From Vision to Reality in the Rare Disease Space
- W-22: Tell Me More: Exploring Patient Perspective on the Benefits and Disadvantages of Drugs During Clinical Trials
- W-23: Evaluation of Publicly Available Patient Medical Education Videos on Breast Cancer
- W-25: Bring your own Wearable (BYOW): Considerations for Clinical Research
- W-26: Educational, Gender, and Age Diversity in the Corporate Leadership of Fortune 500 Pharmaceutical Companies
- W-27: Identifying Gaps in Competitive Intelligence and Business Development Strategy: Opportunities in the PD-1/PD-L1 landscape
- W-28: Main Difference between Quality Tolerance Limits and Key Risk Indicators
- W-29: Single Pivotal Trial Characteristics Supporting Regulatory Approval of Non-orphan, Non-oncology Drugs in EU and US, 2012 – 16
- W-30: Analysis of Products Awarded the Rare Pediatric Disease Priority Review Voucher and the Impact of Advancing Hope Act
- W-31: A Retrospective Analysis of Bridging Study Evaluation in Taiwan During 2011-2018: Focus on Multi-Regional Clinical Trials
- W-32: Evaluation of Branded Prescription Drug Facebook Messenger Responses to Consumer Requests for Product Information
- W-34: FDA Advisory Committee Meetings: A Five-year Retrospective Analysis
- W-35: Regulatory Flexibility in the Review of Biologics for Rare Diseases
- W-36: Prescribers’ Perception of the PLLR When Making Clinical Decisions for Patients with Chronic Respiratory Conditions
- W-37: Evaluation of ICH Q12 Implementation Readiness
- W-38: Defining the Methodology for Interim Analysis and Data Peek for Power in Late Phase Research and Pragmatic Clinical Trials.
- W-39: Using Synthetic Control Databases to Accelerate Indication-Specific Safety and Efficacy Evidence
- W-41: Targeted Review of Adverse Events of Special Interest (AESI)
- W-42: Performance of Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies
- W-43: Calcitonin Gene Receptor Peptide (CGR) Antibodies: Real-world Evidence on Acute Migraine Treatment
- W-44: New Methods for Analyzing Clinical and Cost Outcomes in RA With Interactive Visual Analytics
- W-45: The Impact of US FDA Breakthrough Designation (BTD) on Global Access to Innovative Medicines
- W-9: Exploring Accuracy of Abdominal Pain Reporting with and Without Specific Instruction