This year we have designed the academy as a 1-credit course, BIST 5092. This two-week summer academy will be an immersive, collaborative, dynamic and academic experience for students who are planning to pursue a career as a statistician/programmer in pharmaceuticals and health analytics. The course will teach the basics in pharmaceutical statistics using a project-based learning approach. The content of the course is heavily enriched by real drug examples across different therapeutic area. Students will learn by actively engaging in real-world project for drug development. We hope to bring many of the tools, the newer designs and methods which are used in practice but are rarely covered in school, directly to the students who can benefit from learning them and finding their passion in such a role. It will also cover the use of the software in design and analysis of clinical trials. This course is specifically designed for our current BIST MS students and is also open to STAT MS, PhD and UG students, including non-UConn students (non-BIST students), please see course registration instruction below for more details..
The course will teach the basics in pharmaceutical statistics using a project-based Learning approach. The content of the course is heavily enriched by real drug examples across different therapeutic area. And the students will learn by actively engaging in real-world project for drug development. It will also cover the use of the software in design and analysis of clinical trials.
Students can choose to be fully remote during the course. However, as the instructors will be on campus on July 25, 2022, we encourage students to be there in person as well, if it is feasible and take advantage of the planned afternoon Lunch and Meet.
30% attendance.
10% Homework 1, 10% Homework 2, 10% Homework 3: Homework is due on August 5th. Office hours will be provided as indicated below.
40% project slides and presentation. As indicated in the course description, we will take a project based learning approach. The project we will work on is a real drug. Background materials and data are available in the course content area. The background material includes the phase II and III protocols and related publications for Brodalumab-a drug to treat Psoriasis and other autoimmune disease. In addition, it includes the full package for the FDA advisory committee meeting, one summary from sponsor and one summary from FDA. The data are simulated pseudo data to mimic the summary statistics in the publication of results. It would be beneficial to read the full package of background materials to understand the big picture of drug development process, especially the clinical stage.
You are encouraged to form teams by yourselves to work on the course project. You may create a post in Discussion Board to recruit members. If you successfully form a team, please inform us at qiqi.deng@uconn.edu and Dooti.roy@uconn.edu by 5:00PM EST on July 30. If we don't hear from you before that, you will be assigned to one of the teams and the teams will be announced by August 1. You will have one more chance to switch teams by sending emails to me before 5:00PM EST on August 2. After that, the teams will start to work on the projects. We encourage the team members to set up calls as needed among themselves to discuss the project. If you have any questions, feel free to reach out to us by email or come to our office hours.
Included in your course is the access to Statistics in Pharmaceuticals (SIP) conference August 22-23. We will provide a code to waive your registration fee. It can be on-site or virtual attendance. Although it is not required, it is encouraged that you may submit your poster for SIP conference. The instruction for submission in at https://events.stat.uconn.edu/SIP2022/#poster. The submission deadline is August 19.
Once completed, please send your presentation to us. On August 19, we will have presentations for the course project. Each team will have up to 30 minutes to present. Details slot and order will be provided later based on number of teams formed. Dooti and Qiqi will grade your project work based on your presentation.
Download the course plan and assessment criteria.
| Days | Time | Topic | Presenter | Homework | Office hour |
|
Monday 7/25/2022 (Instructors on campus) |
9:00-10:30 |
Overview of phase I/II/III clinical trial Development process |
Qiqi Deng Dooti Roy (Room: AUST 344 for students on site) |
Information relevant for the project (case study) | |
| 10:30-10:45 | Break | ||||
| 10:45-11:30 | Case study (Part 1): Background of the project, Clinical Development Plan | ||||
| 12:00-2:00 | Lunch and Meet | ||||
|
Tuesday 7/26/2022 |
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 7/27/2022 |
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 | ||
| 9:45-10:00 | Break | ||||
| 10:00-12:00 | Data Standard (CDISC/SDTM/ADaM) and statistical programming of clinical trials | Hongli Lu | |||
|
Thursday 7/28/2022 |
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 |
Qiqi Deng | HW1 | |
|
Friday 7/29/2022 |
9:30-11:30 |
Estimand in clinical trials
Examples of intercurrent events and missing data across different Therapeutic areas. |
Qiqi Deng | HW2 | 2:00-3:00 |
| Days | Time | Topic | Presenter | Homework | Office hour |
|
Monday 8/1/2022 |
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. |
||||
| 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 | ||||
| 12:30-2:00 | Resume/CV Presentation and Lab | ||||
| 2:00-3:00 | Building a LinkedIn Profile/Optimizing Your Use of LinkedIn | ||||
|
Tuesday 8/2/2022 |
9:30-11:30 |
Multiplicity adjustment
|
Dooti Roy | HW3 | 2:00-3:00 |
|
Wednesday 8/3/2022 |
9:30-11:30 | Adaptive Design | Qiqi Deng | ||
|
Thursday 8/4/2022 |
9:30-11:30 |
Leverage historical data and data synthesis.
|
Dooti Roy | ||
|
Friday 8/12/2022 |
Office hour only for project related questions. |
Qiqi Deng Dooti Roy |
1:00-2:00 | ||
|
Friday 8/19/2022 |
10:00-12:30 | Project presentation | Qiqi Deng, Dooti Roy and all students | ||
| 8/22-23, 2022 |
Attending Statistics in Pharmaceuticals Conference |