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

Abstract

BackgroundInclusion 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. MethodsPhase 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 Fisher Exact tests. Independent sample t-tests were used to assess the variability in total number of criteria. ResultsOrgan function requirements listed on clinicaltrials.gov are more often vague or incomplete in industry sponsored trials compared to government/cooperative group (p = 2.3 × 10−10, α = 0.01) and academic (p = 1.8 × 10−4, α = 0.01) sponsored trials. Industry sponsored trials more often excluded patients with worse performance status scores compared to government/cooperative group sponsored trials (p = 5.7 × 10−6, α = 0.01). ConclusionIndustry sponsored NSCLC drug trials are more likely to exclude patients with worse performance status and are less transparent in listing complete study requirements on clinicaltrials.gov. Policy summaryUnnecessarily strict enrollment criteria are increasingly seen in clinical trials sponsored by industry. Regulators responsible for drug approvals should note when studies deviate from ASCO and Friends of Cancer Research framework and question the external validity of study findings with overly narrow enrollment criteria when making decisions on drug approvals.