Seamless trials in oncology: A cross-sectional analysis of characteristics and reporting.

ABSTRACT:

Objectives

Seamless clinical trials have received much attention as a possible way to expedite drug development. The growing importance of seamless design can be seen in oncology research, especially in the early stages of drug development. Our objective is to examine the basic characteristics of seamless early-phase oncology trials registered on the ClinicalTrials.gov database and to determine their results reporting rates. We also aim to identify factors associated with results reporting.

Methods

Cross-sectional study. We defined seamless early-phase trials as either those registered as Phase 1/2 or Phase 1 with planned expansion cohort(s). Using the ClinicalTrials.gov registry, we searched for interventional cancer clinical trials with primary completion date (PCD) betwee

SUBMITTER: Klas K 

PROVIDER: S-EPMC11614237 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature