Expectations, experiences and preferences of patients and physicians in the informed consent process for clinical trials in oncology

Expectations, experiences and preferences of patients and physicians in the informed consent process for clinical trials in oncology
Original Article
Laura Gangeri, Sara Alfieri, Margherita Greco, Marta Scrignaro, Elisabetta Bianchi, Paolo Casali, Davide Ferraris, Claudia Borreani
Supportive Care in Cancer, 7 October 2021
Abstract
Purpose
The aim of the present study was to explore (1) informed consent (IC) representations, level of understanding, needs, and factors that influence the willingness of cancer patients to participate in randomized controlled trials (RCTs) (phase I) and (2) representations, experiences, and critical issues of physicians involved in the same process (phase II).
Methods
Semi-structured interviews were conducted with 20 cancer patients who had been asked to enroll in a phase II/III RCT (phase I). Two focus groups were conducted with 13 physicians enrolled in the same process (phase II). The content produced was analyzed through a thematic analysis.
Results
The themes that emerged in the first phase I were grouped into six categories: IC representation, randomization, experimentation, meeting with the physician, factors that influence the willingness to participate, and trial participants’ needs. The themes emerged in the phase II were grouped into four: IC representation, critical issues of the IC, relationship, and recruitment of trial participants. Each theme is articulated into sub-themes and deeply discussed.
Conclusion
This study highlights (1) the gap between what is ethically demanded in a RCT consultation and the reality of the situation and (2) the difference in perceptions between patients and physicians with reference to the meaning, objectives, and level of understanding of IC.

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