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Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
Published on: June 17, 2015
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Time toxicity associated with early phase clinical trial participation
U Nindra1, G Shivasabesan2, S Childs2
1Department of Medical Oncology, Liverpool Hospital, Liverpool; Ingham Institute for Applied Medical Research, Liverpool; School of Medicine, Western Sydney University, Sydney.
ESMO Open
|November 18, 2023
Summary
Patients in early phase cancer clinical trials (EPCTs) spend a significant amount of time interacting with healthcare systems. Efforts to streamline visits are needed to reduce this burden, which is termed "time toxicity" (TT).
Area of Science:
- Oncology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- Early phase cancer clinical trials (EPCTs) are crucial for developing new cancer therapies.
- These trials involve experimental drugs and focus on dose determination and safety.
- EPCTs are highly time-intensive for both clinicians and patients.
Purpose of the Study:
- To quantify the patient time consumed during participation in early phase cancer clinical trials.
- To define and measure 'time toxicity' (TT) as a composite metric.
Main Methods:
- Retrospective audit of patients in the EPCT unit at Liverpool Hospital (2013-2023).
- Defined 'time toxicity' (TT) as days with any healthcare system contact (visits, infusions, procedures, blood work).
Main Results:
- 219 patients across 36 EPCTs were analyzed.
- Patients spent a median of 29% of their days in healthcare system contact.
- Protocol visits were the main contributor to TT, but unscheduled visits due to adverse events were significant in 7% of patients.
- TT decreased with more treatment cycles completed; patients completing >10 cycles spent 14% of days in contact vs. 35% for those completing ≤2 cycles.
Conclusions:
- This study is the first to report TT in EPCTs with extended follow-up.
- Clinicians should consider TT when discussing trial risks/benefits.
- Streamlining healthcare visits in EPCTs is recommended to minimize patient time burden.
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