Youwei Bi, PhD: No financial relationships to disclose
Dose modification and interruptions in oncology clinical trials are very common. Typical exposure-response analyses based on the steady-state exposure or an accumulated exposure/ dose intensity and the cause-and-effect relationships interpreted thereafter are likely to be confounded due to the time-varying dosing. Awareness of these phenomena and application of appropriate methodology is important in both study design and data analysis to avoid misinterpretation of the exposure-response and dose-response relationships. Regulatory experience and current thinking will be discussed in this presentation.
