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Life sciences · Journal article
JCO Oncology Practice · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a descriptive, protocol-based analysis that demonstrates the feasibility of a novel time-toxicity quantification framework applied retrospectively to 32 lung cancer trial protocols. The study reports higher median time-toxicity units (TTU) in contemporary trials (2015–2024) versus earlier studies (2005–2014), but provides no direct patient-level evidence of actual burden or clinical consequences. Prospective validation and patient-reported outcomes remain necessary to establish clinical utility.
Retrospective protocol analysis. Protocols from clinical trials associated with US FDA approvals of oral lung cancer therapies, published between 2005 and 2024.. Intervention: Time-toxicity metric applied retrospectively to protocol schedules of events.. Compared with: Comparison of time burden between trials published 2005–2014 versus 2015–2024.. n = 32. United States (protocols from FDA-approved trials)..
Median TTT was 63.8 hours (IQR 41.8–109.3) in 2005–2014 trials versus 82 hours (IQR 50.3–139.5) in 2015–2024 trials (P = 0.042) Median TDHC was 14 days (IQR 10–21) in 2005–2014 versus 15 days (IQR 11–44) in 2015–2024 (P = 0.16) 32 phase-specific protocols from FDA-approved oral lung cancer therapies analysed across two decades
No report of inter-rater reliability or sensitivity analysis for time-toxicity unit assignment assumptions.
This work demonstrates a structured method for quantifying protocol-imposed time burden but does not yet provide evidence that time-toxicity units correlate with patient-reported burden, trial dropout, or clinical outcomes. Clinicians should recognize this as a methodological framework requiring prospective validation before use in informed consent discussions or protocol design decisions.
Descriptive analysis of protocol-derived metrics across historical trials with no patient-level validation, establishing feasibility of a novel measurement framework rather than testing clinical impact.
As stated by the source record.
Quoted from the source exactly as published.
This work demonstrates a structured method for quantifying protocol-imposed time burden but does not yet provide evidence that time-toxicity units correlate with patient-reported burden, trial dropout, or clinical outcomes. Clinicians should recognize this as a methodological framework requiring prospective validation before use in informed consent discussions or protocol design decisions.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
PURPOSE Participation in clinical trials imposes additional time commitments beyond routine care; however, trial-associated time toxicity (TT) remains underinvestigated and poorly characterized. The purpose of this study was to develop a scalable, procedure-based metric to quantify total time required for trial participation using the protocol schedule of events. We applied this framework to lung cancer clinical trials to estimate trial-associated burden and explore changes in TT over time. MATERIALS AND METHODS Protocols for clinical trials associated with United States (US) Food and Drug Administration (FDA) approvals of oral lung cancer therapies were obtained from public sources. Using each protocol's schedule of events, study-mandated procedures were assigned time toxicity units (TTUs) based on standardized time estimates. TTUs for each procedure were multiplied by their frequency and summed for screening through cycle 5 to determine a trial's total time toxicity (TTT). Days with health care contact (DHC) were summed over the same period to determine total DHC (TDHC). Median (m) TTT and TDHC were compared between studies published in 2005-2014 and 2015-2024 to assess temporal trends. Two-sample Mann-Whitney U tests were used for nonparametric comparisons. RESULTS Thirty-two phase-specific protocols from trials published between 2005 and 2024 were included. Among studies published in 2005-2014 (n = 7), the median TTT (mTTT) was 63.8 (41.8-109.3) versus 82 (50.3-139.5) in 2015-2024 (n = 25) ( P =.042). Corresponding median TDHC values were 14 (10-21) versus 15 (11-44), respectively ( P =.16). CONCLUSION More contemporary studies demonstrated higher TTT, with significantly greater mTTT observed in studies published in 2015-2024 versus 2005-2014. TDHC demonstrated less sensitivity in capturing differences in time burden. These findings demonstrate the feasibility and practical applicability of the proposed TT framework for characterizing protocol-associated time burden. Prospective validation and broader implementation may help inform patients and encourage streamlined protocol development.
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