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The participation rate in early phase clinical trials for advanced cancer patients has increased in recent years. The highlighting of the therapeutic benefits for the patients involved raises the question of the regulation of the relevance of these trials as a form of care outside of legal drug frameworks. Based on a series of studies on early clinical research, this article shows that this regulation largely stems from healthcare professionals while being subject to the availability of trials, which in turn is subject to economic and scientific regulation on the part of drug manufacturers. This situation of restricted professional regulation limits the possibility of establishing general criteria on the therapeutic relevance of early clinical trials beyond a case-by-case assessment of patient journeys.