Is financial toxicity captured in quality of life assessments in oncology randomized clinical trials?
Related Experiment Video
Updated: Aug 2, 2025
Evaluating the Role of Mitochondrial Function in Cancer-related Fatigue
Published on: May 17, 2018
Timothée Olivier1, Alyson Haslam2, Vinay Prasad2
1Department of Oncology, Geneva University Hospital, 4 Gabrielle-Perret-Gentil Street, 1205 Geneva, Switzerland; Department of Epidemiology and Biostatistics, University of California San Francisco, 550 16th St, 2nd Fl, San Francisco, CA 94158, USA.
Background:
Financial difficulties in relation with diagnosis and treatment of patients with cancer affects their quality-of-life (QoL). We aim to characterize how financial toxicity was captured in oncology randomized clinical trials (RCTs), and to estimate how often the study-drug or other expenses were covered by sponsors.
Methods:
This was a cross-sectional analysis of articles published in six high impact journals (The New England Journal of Medicine, The Lancet, JAMA, The Lancet Oncology, Journal of Clinical Oncology, and JAMA Oncology). Selected articles needed to report on a RCT published between January 2018 and December 2019, study an anti-cancer drug, and have reported QoL results. We abstracted the QoL questionnaires used; whether the survey was directly assessing financial difficulties; whether a difference in financial toxicity was reported between arms; and whether the sponsor supplied the study-drug or covered other expenses.
Results:
For all 73 studies that met inclusion criteria, 34 studies (47%) utilized QoL questionnaires without direct assessment of financial difficulties. The study drug was provided by the sponsor in at least 51 trials (70%), provided according to local rules in 3 trials (4%), and undetermined in the remaining 19 trials (26%). We found 2 trials (3%) with payments or compensation to enrolled patients.
Conclusion:
This cross-sectional study found 47% of articles reporting on QoL in oncology RCTs did not use QoL questionnaires directly assessing financial toxicity. Additionnaly, the study drug was supplied by the sponsor in most trials. Financial toxicity occurs in real-life settings when patients have to pay for the drugs and other medical expenses. QoL assessments from oncology RCTs lack generalizability to real-world settings, due to limited querying of financial toxicity.
Policy Summary:
Real-world evidence could be demanded by regulators as post-requirement studies to ensure QoL results observed in trials will replicate in patients treated outside investigational trials.
Related Concept Videos
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:21Cancer Survival Analysis
02:20Longitudinal Research
01:27Nursing Ethical Principles II
Consider the following scenario, which illustrates how these principles are applied in the care of Mr. John, a fifty-year-old teacher diagnosed with metastatic liver cancer.
Initially, Mr. John's...
01:20Actuarial Approach
Consider the example of a high-risk surgical procedure with significant early-stage mortality. A two-year clinical study is conducted,...
02:49Cancer Therapies
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...