Signing up for an early clinical trial: How important is the physician-patient relationship in the patient's choice?

A precondition of any clinical trial in the biomedical area is the signature of the informed consent form by the patient. Through his signature, the patient engages  in a mixed process of treatment and research. The specificity of early phase trials is to recruit therapeutic failure patients   usually looking for the yet unestablished efficacy of a new drug while these trials relates to its toxicity. We consequently expect the patient's decision to join the trial to be the result of his  perception of the situation, that is an overvaluation of  therapeutic effects. Our work aims to shed some light on to what extent the physician-patient relationship, as a generative factor of the patient's perception, is involved in the production of the rules enlisted by the patient during the face-to-face signature consultation.

 We investigate this issue through the case of a French research unit devoted to the early clinical trials in oncology, with observations during patients' inclusion consultations and semi-structured interviews both with patients and their regular physician. In this research unit, the patient undergoes a double-break: he leaves his regular physician for a new one and moves from a cure-oriented process to a research program. This double-break allows an observation window of patient's self-presentation during the signature consultation. Those observations induce a natural analysis in terms of micro-sociology by using Goffman’s symbolic interactionism and Becker’s perspective on learning and social control.

 This research, carried out with an interactionist approach, mainly will have two degrees of results. First, it will clarify what appears as a form of social control – the physician-patient relationship – in the face-to-face interaction of the signature. Second, it will be an empirical contribution to the analysis about free consent, often left to philosophers and bioethicists.