Biostatistics Commons^™

Bivariate Generalization Of The Time-To-Event Conditional Reassessment Method With A Novel Adaptive Randomization Method, Donglin Yan

Theses and Dissertations--Epidemiology and Biostatistics

Phase I clinical trials in oncology aim to evaluate the toxicity risk of new therapies and identify a safe but also effective dose for future studies. Traditional Phase I trials of chemotherapies focus on estimating the maximum tolerated dose (MTD). The rationale for finding the MTD is that better therapeutic effects are expected at higher dose levels as long as the risk of severe toxicity is acceptable. With the advent of a new generation of cancer treatments such as the molecularly targeted agents (MTAs) and immunotherapies, higher dose levels no longer guarantee increased therapeutic effects, and the focus has shifted …