2022 CASA Spring Traveling Course
Instructors: Dr. Frank Bretz, Novartis; Dr. Dong Xi, Gilead Sciences
9:00 am-4:00 pm (Central Time) on Wednesday, May 25, 2022
Clinical trials play a critical role in pharmaceutical drug development. New trial designs often depend on historical data, which, however, may not be accurate for the current study due to changes in study populations, patient heterogeneity, or different medical facilities. As a result, the original plan and study design may need to be adjusted or even altered to accommodate new findings and unexpected interim results. Through carefully thought-out and planned adaptation, the right dose can be identified faster, patients can be treated more effectively, and treatment effects evaluated more efficiently.
This one-day short course will introduce different types of adaptive designs tailored for adaptive dose finding and confirmatory clinical trials. Practical considerations will be illustrated with case studies. Types of adaptive clinical trial designs covered in this course include adaptive dose finding studies using optimal designs to allocate new cohorts of patients based on the accumulated evidence, group sequential designs, blinded and unblinded sample size re-estimation as well as adaptive designs for confirmatory trials with treatment or population selection at interim.
Please contact Dr. Ruofei Du (firstname.lastname@example.org) for acquiring the zoom link.