Dr Herrmann on Assessing Time Toxicity in Lung Cancer Trials

“We've seen an increase in time [toxicity] over time in phase 1 through 3 trials, and this is something that we'd like to validate prospectively by applying this to patients who are [currently enrolled in] clinical trials.”

Amanda Herrmann, MD, a third-year hematology/oncology resident at University of California, San Diego, discusses findings from the TIME TOX Lung study, which retrospectively assessed the time toxicity associated with lung cancer clinical trials. This study aimed to quantify the burden of clinical trial participation by analyzing the time commitment required for patients enrolled in trials evaluating oral targeted therapies for lung cancer.

The analysis focused on previously completed phase 1 through 3 trials, applying a retrospective methodology to estimate the cumulative time burden imposed by trial participation. Results indicated an increase in time toxicity over successive trial phases, suggesting that patients are required to commit more time to study-related activities as therapeutic development progresses. This metric of time toxicity encompasses various factors, including clinic visits, treatment administration, monitoring, and follow-up evaluations.

Herrmann emphasizes that although these findings provide proof of concept, further validation is necessary. The study's retrospective design limits its applicability in real-time trial planning. To address this, Herrmann proposes a prospective application of time toxicity metrics in ongoing trials, allowing for real-time assessment and integration into clinical trial development. The ultimate goal is to incorporate time toxicity as a standard consideration when designing and evaluating clinical trials, ensuring that patient burden is minimized without compromising the integrity of the research.

By prospectively validating this methodology, researchers hope to refine trial design strategies that balance efficacy and feasibility without producing unnecessary time burdens for patients. Herrmann underscores that improving trial efficiency is critical, particularly for patients with advanced lung cancer who often have limited time and require optimized treatment schedules that maximize therapeutic benefit and maintain quality of life.