| Days | Time (EST) | Topic | Presenter | Homework | Office hour |
|---|---|---|---|---|---|
| Monday 7/8/2024 | 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 7/9/2024 | 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 7/10/2024 | 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 |
||
| 9:45-10:00 | Break | ||||
| 10:00-12:00 | Data Standard (CDISC/SDTM/ADaM) and statistical programming of clinical trials | ||||
| Thursday 7/11/2024 | 9:30-11:30 | Basics for sample size calculation in clinical trials: methodology, examples and implementation using software
|
Xiaofei Bai | HW1 | |
| Friday 7/12/2025 | 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 7/15/2024 | CCD Career Development Day | UConn CCD
Kaitlyn Anderson |
|||
| 10:00-12:00 | Becoming Career Module – Watch the course | ||||
| 12:00-1:00 | Lunch | ||||
| 1:00-2:00 | Articulating Your Competencies | ||||
| 2:00-2:30 | Discussion and Q/A | ||||
| Tuesday 7/16/2024 | 9:30-11:30 | Multiplicity adjustment
|
Dooti Roy | HW3 | 2-3pm |
| Wednesday 7/17/2024 | 9:30-11:30 | Adaptive Design | Xiaofei Bai | ||
| Thursday 7/18/2024 | 9:30-11:30 | Leverage historical data and data synthesis.
|
Dooti Roy | ||
| Friday 8/2/2024 | Office hour only for project related questions | Dooti Roy Xiaofei Bai |
9:00-10:00 | ||
| Monday 8/12/2024 | 9:00 – 10:30 | Project presentation | Dooti Roy
Xiaofei Bai and all students |
||