Improving the clinical meaning of surrogate endpoints: An empirical assessment of clinical progression in phase III oncology trials.

ABSTRACT: Disease progression in clinical trials is commonly defined by radiologic measures. However, clinical progression may be more meaningful to patients, may occur even when radiologic criteria for progression are not met, and often requires a change in therapy in clinical practice. The objective of this study was to determine the utilization of clinical progression criteria within progression-based trial endpoints among phase III trials testing systemic therapies for metastatic solid tumors. The primary manuscripts and protocols of phase III trials were reviewed for whether clinical events, such as refractory pain, tumor bleeding, or neurologic compromise, could constitute a progression event. Univariable logistic regression computed odds ratios (OR) and 95% CI for associations between trial-l

SUBMITTER: Sherry AD 

PROVIDER: S-EPMC11449668 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature