Abstract 5579
Background
One of the critical ethical requirements of conducting clinical research regardless of the study setting is to obtain informed consent before enrolling subjects’ participants. It is crucial to ensure quality and validity of the informed consent of study’s participants.
Methods
We used a quantitative survey design using the Italian validated version of the Quality of Informed Consent (QuIC) questionnaire. We included 7 Italian cancer sites and 300 clinical trials patients.
Results
All the patients invited accepted to fill the questionnaire. Most of them were male (N = 130), and the mean age was 60 (sd 10). Most of them were satisfied with the information received, and they considered themselves to be well informed. The average score for objective understanding was 62.2 and for subjective understanding was 74.6 (p < 0.001). Subjects responded correctly to questions about the general understanding of participation in research. Only 33% understood which procedures were experimental, and 40% of respondents knew foreseeable risks or discomfort from the research. In ANOVA analysis, an increased understanding was associated with a higher level of education.
Conclusions
Our results suggest that investigators should invest more effort to improve clinical trials subjects reach a safer understanding of the informed consent. The clinical trials nursing role is crucial to protect the clinical trial participants rights.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Gianluca Catania.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2108 - Biomarker analyses of ramucirumab in patients with platinum refractory urothelial cancer from RANGE, a global, randomized, double-blind, phase 3 study.
Presenter: Michiel Van der Heijden
Session: Poster Display session 3
Resources:
Abstract
3090 - Comparison of Immuno-Oncology (IO) Biomarkers in Adenocarcinoma (ACB), Urothelial Carcinoma (UCB) and Squamous Cell Carcinoma (SCCB) of the Bladder, with interim results from PURE01
Presenter: Daniele Raggi
Session: Poster Display session 3
Resources:
Abstract
5211 - Potential role of a clinical, taxonomical classification and RNA expression integrated signature to predict response to neoadjuvant platinum-based chemotherapy in muscle-invasive bladder cancer (MIBC) patients
Presenter: Albert Font
Session: Poster Display session 3
Resources:
Abstract
3206 - Hyperphosphatemia due to Erdafitinib (a Pan-FGFR Inhibitor) and Anti-tumor Activity Among Patients (Pts) with Advanced Urothelial Carcinoma (UC)
Presenter: Scott Tagawa
Session: Poster Display session 3
Resources:
Abstract
3110 - Prognostic role of FGFR Mutations and FGFR mRNA expression in metastatic urothelial cancer treated with anti-PD(L1) inhibitors in first and second line setting
Presenter: Florian Roghmann
Session: Poster Display session 3
Resources:
Abstract
3564 - Circulating tumour DNA (ctDNA) utility as a biomarker for metastatic urothelial carcinoma (mUC)
Presenter: Jean-Michel Lavoie
Session: Poster Display session 3
Resources:
Abstract
2760 - Comparative analysis of tumor mutational burden (TMB) prediction methods and its association with determinants of the tumor immune microenvironment of urothelial bladder cancer (UBC)
Presenter: Markus Eckstein
Session: Poster Display session 3
Resources:
Abstract
2513 - The Immunoscore in patients with urothelial carcinoma treated with neoadjuvant chemotherapy: clinical significance for pathological response and survival
Presenter: Elise Nassif
Session: Poster Display session 3
Resources:
Abstract
2835 - Genomic analysis of urothelial cancer and associations with treatment choice and outcome
Presenter: David Sarid
Session: Poster Display session 3
Resources:
Abstract
5763 - cfDNA is an acceptable but insufficient means of characterizing FGFR3 mutation in patients with metastatic urothelial cancer (mUC)
Presenter: Sumanta Pal
Session: Poster Display session 3
Resources:
Abstract