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 Normally distributed Endpoint Binary endpoint 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	Future Readiness: Career Development Day		Dooti Roy TBD
	10:00-10:30	Communicating@Work
	10:30-11:30	Workshop/Discussion
	12:30-1:00	Interviewing Right
	1:00-2:00	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