Accuracy and Safety of Novel Designs for Phase I Drug-Combination Oncology Trials*

ABSTRACT: Despite numerous innovative designs having been published for phase I drug-combination dose finding trials, their use in real applications is rather limited. As a working group under the American Statistical Association Biopharmaceutical Section, our goal is to identify the unique challenges associated with drug combination, share industry’s experiences with combination trials, and investigate the pros and cons of the existing designs. Toward this goal, we review seven existing designs and distinguish them based on the criterion of whether their primary objectives are to find a single maximum tolerated dose (MTD) or the MTD contour (i.e., multiple MTDs). Numerical studies, based on either industry-specified fixed scenarios or randomly generated scenarios, are performed to assess their rela

SUBMITTER: Liu R 

PROVIDER: S-EPMC10237505 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature