Exploring Demographic Representation and Reporting in Lung Cancer Clinical Trials with Canadian Sites from 2013 to 2023.

This review evaluates the reporting of demographic characteristics and the diversity of participants of phase III lung cancer clinical trials with Canadian research sites. A literature search was conducted using the ClinicalTrials.gov registry to identify clinical trials conducted between 1 January 2013, and 31 December 2023. The demographic reporting practices and the representation of sex/gender, racial, and ethnic groups were assessed. The location of Canadian research sites was also examined for trends in reporting and representation. Associated publications were reviewed for demographic data collection methods. Of the 25 clinical trials, 24 reported race and 18 also reported ethnicity. All clinical trials reported sex/gender, and the city and province of the participating Canadian sites. Most participants were White (66.1%), identified as not Hispanic or Latino (81.4%), and were male (57.8%). The provinces with the most clinical trial sites were Ontario (43.6%) and Quebec (34.2%). Lung cancer clinical trials lack adequate demographic reporting and representation of females, diverse patient groups, and geographical locations in Canada with high lung cancer incidence rates. Specifically, the Indigenous Peoples of Canada and Nunavut require better representation in lung cancer clinical trials conducted in Canada. These findings highlight the need to improve diversity and demographic representation in clinical research.

Real-World Safety and Effectiveness of a Bevacizumab Biosimilar (ABP 215) in Metastatic Colorectal Cancer Patients in Canada.

BACKGROUND: ABP 215 is a biosimilar to the reference product, bevacizumab, and was one of the first biosimilars approved by Health Canada for the first-line treatment of metastatic colorectal cancer (mCRC). This study aimed to address gaps in real-world evidence (RWE) including patient characteristics, treatment safety (primary objective), and effectiveness (secondary objective) for first-line ABP 215 therapy in Canadian patients with mCRC. MATERIALS AND METHODS: Retrospective data were collected in 2 waves, at least 1 year (Wave 1) or 2 years (Wave 2) after commercial availability of ABP 215 at each participating site. RESULTS: A total of 75 patients from Wave 1 and 164 patients from Wave 2 treated with a minimum of 1 cycle of ABP 215 were included. At least one safety event of interest (EOI) was recorded for 34.7% of Wave 1 and 42.7% of Wave 2 patients. The median progression free survival (PFS) for Wave 1 and 2 patients were 9.47 (95% confidence interval [CI]: 6.71, 11.90) and 21.38 (95% CI: 15.82, not estimable) months, respectively. Median overall survival was not estimable for Wave 1 and was 26.45 months for Wave 2. CONCLUSION: The safety and effectiveness of ABP 215 observed in this real-world study were comparable to clinical trial findings and to other RWE with longer PFS in the current study.