Patient Autonomy in Oncology Clinical Trial Recruitment: Physician Influence, Trust and Ethical Responsibility. short title : Safeguarding Patient Autonomy: A Physician's Responsibility

Abstract Background Informed consent is a fundamental ethical requirement in clinical research, intended to safeguard participants' autonomy. However, decisions to participate in oncology clinical trials are made in contexts characterised by vulnerability, therapeutic uncertainty and asymmetrical physician–patient relationships. This study aimed to explore how decisions to participate in oncology clinical trials are shaped by interactions between patients and physicians, with particular attention to physician influence, patient autonomy and ethical responsibility. Methods An exploratory qualitative study was conducted at a comprehensive cancer centre in France. Semi-structured interviews were carried out with 28 patients who had recently consented to participate in a clinical trial, and interviews were conducted with 18 physicians involved in oncology clinical research. Interview transcripts underwent multidisciplinary thematic content analysis, complemented by lexicometric analysis using IRaMuTeQ, including descending hierarchical classification and correspondence analysis. Results Physicians played a central role in shaping access to clinical trials through their selection of protocols, identification of eligible patients and presentation of therapeutic options. Although they acknowledged their influence on patients' decisions, they rarely explicitly addressed the ethical responsibility associated with this influence. Patients' decisions were shaped by multiple interacting factors, including hope for therapeutic benefit, lack of alternative treatments, family expectations and the desire to contribute to scientific progress. Trust in physicians emerged as a major determinant of participation, often outweighing detailed engagement with written information. Nevertheless, trust did not necessarily imply passivity, as some patients actively sought additional information or deliberately delegated decision-making to their physicians. Conclusions Consent to oncology clinical trial participation is a relational and dynamic process rather than an exclusively individual decision. Physician influence is not inherently incompatible with patient autonomy, but it entails substantial ethical responsibility. Beyond obtaining formal consent, physicians should foster conditions that enable patients to make decisions consistent with their values, preferences and priorities. These findings support a relational approach to informed consent that acknowledges vulnerability, trust and the shared construction of decisions.