Effect of sponsor on enrollment criteria in non-small cell lung cancer clinical trials.

ABSTRACT:

Background

Inclusion and exclusion criteria in clinical trials are used to mitigate the effects of confounding variables on study outcomes. In 2017 and 2021, ASCO and the Friends of Cancer Research published recommendations to loosen enrollment criteria in cancer clinical trials to improve generalizability. The purpose of this study is to determine if the source of funding influences the degree of transparency and selection of inclusion and exclusion criteria.

Methods

Phase 2 and 3 non-small cell lung cancer (NSCLC) drug trials on clinicaltrials.gov were grouped into one of three sponsor categories: industry, government/cooperative group, and academic. Strictness of specific criteria and the level of transparency in listing organ function requirements were analyzed using Fis

SUBMITTER: Cooper RA 

PROVIDER: S-EPMC10226152 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature