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Theses

L'administration de la preuve : la solidarité procédurale au sein des essais cliniques

Abstract : A clinical trial consists of a set of epistemological principles used as a public policy instrument. Its function is to establish the effectiveness of treatments within a framework that ensures the social legitimacy of the production of medical and pharmacological knowledge. From an organizational point of view, it is based on a set of micro-administrative activities to ensure the feasibility of a research protocol, patient safety and the reliability of the data produced.This thesis proposes a sociological analysis of the “administration of evidence” that clinical trials are, and thus, to complete the studies that have so far been essentially devoted to the study of patients’ rights, therapeutic activism or the epistemic organization of research. The French term “administration” refers first of all to the methodological procedures used during the conduct of a trial to prove the effectiveness of a treatment. It then refers to the administrative activities deployed by the plurality of actors in the trial to recruit patients, coordinate clinicians and control the production of clinical data. Given the heterogeneity of the workers involved in a trial and the different normative universes they convey, the organizational contingencies that may compromise the course of events and the atypical control relationships that disrupt the traditional economy of professional hierarchies, how do these actors manage to fit into the bureaucratic organization that clinical trials are and what type of solidarity underlies this administration of proof? To answer this question, we propose to approach the bureaucracy in persons and in activities and to take into account the subject matter of the administrative work, the time involved in setting up and carrying out a trial, as well as the relational dynamics that are played out between the sponsors and the investigators, as well as their support staff. Based on documentary work, observation of meetings and about fifty interviews with investigators, clinical study technicians, clinical study managers, research associates, methodologists and biostatisticians, we maintain that the functioning of a clinical trial is based on a particular form of solidarity: procedural solidarity. The notion refers to the ability of administrative procedures (consent, reporting of adverse events, etc.) to frame and stabilize over time the actions and interactions of the various actors involved in the conduct of a clinical trial and expected to follow a research protocol. After reviewing the history of the bureaucratization of drug evaluation, we follow the steps of the trials step by step, from designing a research protocol to freezing a database to describe the social dynamics of procedural solidarity.
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Submitted on : Tuesday, October 13, 2020 - 3:15:00 PM
Last modification on : Tuesday, May 4, 2021 - 3:04:18 AM

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  • HAL Id : tel-02965808, version 1

Citation

Amélie Petit. L'administration de la preuve : la solidarité procédurale au sein des essais cliniques. Sociologie. Université de Bordeaux, 2018. Français. ⟨NNT : 2018BORD0364⟩. ⟨tel-02965808⟩

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