Dr Jani on the Inclusion of PRO End Points in Lung Cancer Clinical Trials

“Over the past few years, with the last being 2023, [we’ve seen] that only 30% to 35% of trials included in our study had patient-reported outcomes as a part of the trial’s end points, which is extremely low.”

Chinmay Jani, MD, the chief fellow of hematology and oncology at the University of Miami Sylvester Comprehensive Cancer Center discussed findings from a study which examined the rate of inclusion of patient-reported outcome (PRO) end points in clinical trials of patients with lung cancer presented at the OncLive Fellows Forum on Thoracic Oncology, which took place during the 2025 ASCO Annual Meeting.

Study investigators evaluated phase 3 clinical trials that enrolled patients with lung cancer up to 2023, he began. A systemic review of the PubMed database and included 191 articles was conducted in their analysis; the search was completed in February 2024. Subgroup analyses were performed according to cancer subtype and analyses were stratified by publication year.

Findings from the study revealed that 31.93% of studies included quality of life (QOL) as an end point, Jani explained. The rates of inclusion of PROs as an end point among clinical trials that enrolled patients with early-stage disease and small cell lung cancer (SCLC) were even lower than the overall rate, which was particularly alarming, he noted.

Data from the study also showed that studies in patients with SCLC incorporated QOL end points at a rate of 19.04% compared with 33.72% of clinical trials in patients with non–small cell lung cancer. QOL end points were included in studies of patients with early-stage resectable disease at a rate 26.31% compared with 34.44% for unresectable advanced or metastatic disease.

The inclusion of PROs as a study end point remained stagnant over the period of the analysis, with no increase even in recent years, Jani said. Accordingly, increased efforts should be made by investigators to increase the inclusion of PROs as an end point in upcoming clinical trials, he concluded.