Week 1

Days Time (EST) Topic Presenter Homework Office hour
Monday 7/14/2025   12:30 - 13:00 Virtual meet and greet Dooti Roy
Xiaofei Bai
Information relevant for the project (case study)
13:00 - 14:30 Overview of phase I/II/III clinical trial Development process  
14:30 -14:45 Break
14:45 -15:30 Case study (Part 1): Background of the project, Clinical Development Plan
Tuesday 7/15/2025     9:30-10:25 Case study (Part 2): Introduction to Phase 2 protocol, and Statistical Considerations Dooti Roy  
10:25-10:35 Break
10:35-11:30 Case study (Part 3):  Introduction to Phase 3 protocol, and Statistical Considerations
Wednesday 7/16/2025 8:30-9:45 Role of Statisticians in a clinical trial conduct.
Trial statistical analysis plan (TSAP)
Trial oversight meetings during trial conduct
Database Lock and Clinical Study Report
Dooti Roy
Hongli Lu,
TBD
9:45-10:00 Break
10:00-12:00 Data Standard (CDISC/SDTM/ADaM) and statistical programming of clinical trials
Thursday 7/17/2025 9:30-11:30 Basics for sample size calculation in clinical trials: methodology, examples and implementation using software
  1. Normally distributed Endpoint
  2. Binary endpoint
  3. Survival endpoint
Xiaofei Bai HW1
Friday 7/18/2025 9:30-11:30 Estimand in clinical trials Examples of intercurrent events and missing data across different Therapeutic areas. Xiaofei Bai HW2 2-3pm


Week 2

Days Time (EST) Topic Presenter Homework Office hour
Monday 7/21/2025     CCD Career Development Day Dooti Roy
Xiaofei Bai
TBD
Kaitlyn Anderson
10:00-12:00 Communicating@Work
10:45-12:00 Workshop/Discussion
1:00-1:45 Interviewing Right
1:45-2:30 Workshop/Discussion
Tuesday 7/22/2025 9:30-11:30 Multiplicity adjustment
  • A review of FDA and EMA guidance about multiplicity adjustment
Dooti Roy HW3 2-3pm
Wednesday 7/23/2025   9:30-11:30 Adaptive Design Xiaofei Bai
Thursday 7/24/2025     9:30-11:30 Leverage historical data and data synthesis.
  • Borrowing historical information
  • Borrowing adult trial data for pediatric development
  • Synthesis of data from different resources.
Dooti Roy
Friday 8/1/2024   Office hour only for project related questions Dooti Roy
Xiaofei Bai
9:00-10:00
Friday 8/8/2025     9:00 – 10:30   Project presentation   Dooti Roy
Xiaofei Bai and all students