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
|
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 |
Days | Time (EST) | Topic | Presenter | Homework | Office hour |
---|---|---|---|---|---|
Monday 7/21/2025 | CCD Career Development Day | Dooti Roy Xiaofei Bai TBD Kaitlyn Anderson |
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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
|
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.
|
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 |