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Monday, June 13
 

2:00pm CDT

12P: Defining the Clinical Questions of Interest: Why Everyone Developing a Protocol Should Understand Estimands! Virtual
 
Tuesday, June 14
 

10:00am CDT

21A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved in Clinical Trials Virtual
 
Monday, June 20
 

1:15pm CDT

#110: Adaptive Designs Save Time and Money: Regulatory Agencies Accept Them - Why Aren’t They Used More? Room 178 #112: ICH Q2 (R2) and Q14: Can We Realize the Vision for Risk-Based Approvals of Analytical Procedures and Changes? Room 180

1:30pm CDT

#117: The Translational Value of Animal Models in Rare Diseases Room 183 C #120: Practical Applications of the Estimand Framework in Novel, Complex Settings Room 185 AB

4:00pm CDT

#143: A Targeted Learning Framework for Causal Effect Estimation Using Real-World Data Room 183 B
 
Tuesday, June 21
 

11:15am CDT

#231: Leveraging Real-World Evidence for Regulatory Purposes Room 187

2:00pm CDT

#255: Demystifying Statistical Concepts for Non-Statisticians Involved with Clinical Trials Room 470 A

4:15pm CDT

#273: IMPALA (IntercoMPany quALity Analytics) Industry Group: Data Science Development and Other Collaboration Updates Room 470 B #276: Rethinking Fundamental ICH CMC Guidelines: Analytical Procedures, Stability, Specifications, and Risk Assessment Room 176 #277: Quantitative Benefit-Risk Approaches in Drug Development and Approval: Examples from FDA and Industry Room 185 AB
 
Wednesday, June 22
 

9:00am CDT

#305: What’s New at ICH? From the E11A Pediatric Extrapolation Guideline to Model Informed Drug Development (MIDD) Room 175 #307: Improve the Speed and Cost of Clinical Trials With Bayesian Approaches: Unpacked for Non-Statisticians Room 180

11:15am CDT

#329: Complex Innovative Design: What’s in Name? A Global Perspective on the Changing Design Landscape Room 185 CD

1:45pm CDT

#345: Statistical Issues in Master Protocols: Beyond Type I Error and Concurrent Controls Room 180

4:15pm CDT

#377: Choosing the Most Convincing Clinical Endpoints in Cancer Clinical Trials: How to Balance Different Perspectives? Room 470 B
 
Thursday, June 23
 

10:00am CDT

#412: Novel Visualization Tools for Safety Assessment: An Initiative Based on Multidisciplinary Collaboration Room 185 CD
 
Monday, June 26
 

10:45am CDT

E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards in Clinical Trials and NDA/BLA Submissions to FDA TBD

1:30pm CDT

Advances in Real-World Evidence: Randomized Clinical Trials Duplicate, Publication Scandal, and China’s Real-World Evidence Heaven TBD
 
Tuesday, June 27
 

10:30am CDT

The Full Picture: Innovative Software Tools for Data Insight Generation TBD

1:15pm CDT

Quality in the Real World: Diagnosing and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data TBD

4:00pm CDT

Patient-Preferences and Multistate Models to Enhance Patient-Focus of Traditional Endpoints in Oncology TBD
 
Wednesday, June 28
 

10:30am CDT

Patient-Focused Drug Development in Rare Disease Endpoint Selections TBD

1:15pm CDT

Opportunities and Issues with Existing Analytical Technologies for Safety Monitoring of Ongoing Clinical Studies TBD

4:00pm CDT

From 1000's of Tables to Summarizing Clinical Trials Graphically TBD
 
Thursday, June 29
 

8:30am CDT

Demystifying Statistical Concepts for ANYONE Involved with Clinical Trials TBD

9:45am CDT

Statistical Applications of Machine Learning (ML) and Artificial Intelligence (AI) in Drug Development and Success Stories of Application TBD
 
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Exh Hall Community Area
Exhibit Hall
Exhibit Hall Booth #1719
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Level 3 F2 Entrance
Meeting Rm Lobby Level 1
Meeting Room Lobby
Room 175
Room 176
Room 178
Room 179
Room 180
Room 183 A
Room 183 B
Room 183 C
Room 184
Room 185 AB
Room 185 CD
Room 186
Room 187
Room 375 A Zone 1
Room 375 A Zone 2
Room 470 A
Room 470 B
Room 471 A
Room Skyline 375 CDE
Skyline Ballroom Foyer
TBD
Virtual
  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • AI and Machine Learning
  • COVID-19
  • Data Science
  • Decentralized Trials
  • Digital
  • Diversity Equity and Inclusion
  • Innovative Trial Design
  • Patient Perspective
  • Personalized Health Care
  • Regulator Perspective
  • Remote Work
  • RWD-RWE
  • Special Populations
  • Student Programming