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

Ryan A Cooper; Yan Chai; Jorge Nieva

doi:10.1016/j.jcpo.2022.100336

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

J Cancer Policy. 2022 Sep:33:100336. doi: 10.1016/j.jcpo.2022.100336. Epub 2022 May 20.

Authors

Ryan A Cooper¹, Yan Chai², Jorge Nieva³

Affiliations

¹ University of Southern California Keck School of Medicine, 1975 Zonal Ave, Los Angeles, CA 90033, USA. Electronic address: ryanacoo@usc.edu.
² Biostatistics Core, The Saban Research Institute and Southern California Clinical and Translational Science Institute, Children's Hospital Los Angeles Los Angeles, 4551 Sunset Blvd, Rm. 102 MS 142, Los Angeles, CA 90027, USA. Electronic address: achai@chla.usc.edu.
³ University of Southern California/Norris Cancer Center, 1441 Eastlake Ave, Los Angeles, CA 90033, USA. Electronic address: jorge.nieva@med.usc.edu.

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 Fisher Exact tests. Independent sample t-tests were used to assess the variability in total number of criteria.

Results: Organ 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).

Conclusion: Industry 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 summary: Unnecessarily 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.

Keywords: Clinical trials; Clinicaltrials.gov; Enrollment criteria; Non-small cell lung cancer; Sponsor.

Publication types

Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural

MeSH terms

Carcinoma, Non-Small-Cell Lung* / drug therapy
Clinical Trials as Topic
Drug Approval
Drug Industry
Government
Humans
Lung Neoplasms* / drug therapy

Abstract

Publication types

MeSH terms

Grants and funding