Examining informed consent quality in oncology clinical trial participants: A cross-sectional study

This cross-sectional study was designed to assess the informed consent quality in cancer clinical trials in China. We further examined the consistency between cancer patients' objective knowledge and subjective understanding of the trial, as well as patient-related factors that influence the quality of informed consent.

This cross-sectional research was conducted at a tertiary cancer hospital in Beijing, China, between April 2023 and March 2024. To assess objective knowledge and subjective understanding of the consent provision and clinical trial, all participants completed a form comprising demographic items and the Quality of Informed Consent Questionnaire. Data were analyzed using correlation analyses, descriptive statistics, and quantile regression.

For 304 cancer patients, the median objective knowledge as well as subjective understanding scores were 69.20 (IQR, 60.08-76.90) and 61.60 (IQR, 37.50-82.10), respectively. The correlation coefficients of the total score and each dimension between objective knowledge and subjective understanding ranged from 0.113 to 0.633, p < 0.050. Quantile regression analysis showed that age, level of education, marital status, primary caregiver, previous participation in clinical trials, and anti-tumor treatment experience significantly influenced both objective knowledge and subjective understanding.

Cancer patients who participated in clinical studies showed moderate informed consent quality. Objective knowledge and subjective understanding of the trial content were significantly positively correlated. The correlations in the "Alternatives" dimension were weak and warrant improvement. The informed consent quality with different patient characteristics was heterogeneous, and the influence of these characteristics varied across quantiles.