Week 1

Days	Time	Topic	Presenter	Homework	Office hour
Monday 7/17/2023 (Instructors on campus)	11:30 - 13:00	Lunch meet and greet (AUST 326)	Dooti Roy Xiaofei Bai (Room: AUST 344 for students on site)	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 7/18/2023	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 7/19/2023	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 7/20/2023	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) Continuous endpoint	Xiaofei Bai	HW1
Friday 7/21/2023	9:30-11:30	Estimand in clinical trials. Examples of intercurrent events and missing data across different Therapeutic areas.	Xiaofei Bai	HW2	14:00-15:00

Week 2

Days	Time	Topic	Presenter	Homework	Office hour
Monday 7/24/2023	CCD Career Development Day (This is a special activity organized by UConn CCD. It is integrated into the short course agenda for easy access of the information.)		UConn CCD
	10:00-10:30	Introductions and Opening Activity
	10:30-11:30	Finding Jobs and Internships Understanding Job Postings and Applicant Tracking Systems
	11:30-12:30	Lunch
	12:30-14:00	Résumé/CV Presentation and Lab
	14:00-15:00	Building a LinkedIn Profile/Optimizing Your Use of LinkedIn
Tuesday 7/25/2023	9:30-11:30	Multiplicity adjustment A review of FDA and EMA guidance about multiplicity adjustment	Dooti Roy	HW3	14:00-15:00
Wednesday 7/26/2023	9:30-11:30	Adaptive Design	Xiaofei Bai
Thursday 7/27/2023	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 8/4/2023		Office hour only for project related questions	Dooti Roy, Xiaofei Bai		13:00-14:00
Friday 8/11/2023	11:00-12:30 13:30-15:00	Project presentation	Dooti Roy, Xiaofei Bai, and all students