everything.study
STAT 643

CLINICAL TRIAL DESIGN, IMPLEMENTATION, AND ANALYSIS

3 credits.

Gain an understanding of fundamental elements of clinical trials (such as objectives, endpoints, surrogate endpoints, and statistical decisions) and statistical design considerations (such as randomization and blinding). Designs of clinical trials for Phase I, II, and III studies including single-arm, two-arm, and drug combination trials. Introduction to adaptive designs for precision medicine and master protocol designs such as umbrella trials and basket trials.

Prerequisites & course information

Requisites: STAT 609 , 610 , B M I/STAT 641 , or graduate/professional standing Course Designation: Core GenEd - Natural Science & Wellness Level - Advanced L&S Credit - L&S Liberal Arts and Science Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Fall 2024 Learning Outcomes: 1. Summarize the objectives of clinical trials and key statistical design components Audience: Both Grad & Undergrad 2. Design the clinical trials and investigate the operating characteristics of the design to implement clinical trials Audience: Both Grad & Undergrad 3. Write the protocol section of statistical considerations and communicate the design of clinical trials to both statisticians and clinicians Audience: Both Grad & Undergrad 4. Build sequential and adaptive methods for clinical trials Audience: Graduate Learning Outcomes: 1. Summarize the objectives of clinical trials and key statistical design components Audience: Both Grad & Undergrad 2. Design the clinical trials and investigate the operating characteristics of the design to implement clinical trials Audience: Both Grad & Undergrad 3. Write the protocol section of statistical considerations and communicate the design of clinical trials to both statisticians and clinicians Audience: Both Grad & Undergrad 4. Build sequential and adaptive methods for clinical trials Audience: Graduate

Sources
Catalogue variants