Mettre en place la médecine de précision au travers d’un essai clinique : le cas du projet pilote en cancérologie du plan France médecine génomique 2025

This doctoral research in the field of sociology aimed to follow the deployment of the France Genomic Medicine Plan 2025 (PFMG 2025) based on the study of one of its pilot project in oncology, the VERYSARC clinical trial. In the context of precision medicine, these types of trials aim to test the integration of high-throughput genome sequencing (NGS) into routine care. Drawing on a qualitative methodology (interviews and participant observation) informed by the sociology of science and health, the investigation questions the boundaries between care and research. The incorporation of the trial into the Plan was done through a process of transformation of the initial objectives of the trial. As part of this transformation, the essay is mobilized in various technoscientific rhetorics aimed at different audiences (patients, researchers, political actors). That said, the promises are not detached from the concrete reality of the trial which remains for the majority of players in the hospital world a major research instrument defined by great organizational complexity. At the CLCC level, the implementation of the trial highlights organizational dysfunctions. Despite a long socio-history of links between care and research, CLCCs remain a social world governed by and for care. The observations thus made it possible to identify situations of asynchrony, despite the existence of an organizational framework dedicated to coordination, which once again raise the question of the boundaries between care and research. This complexity is also visible in the relationships maintained by the patients included in the trial. We have identified phenomena of ignorance, information deficit and therapeutic illusion. We conclude that all these explanations ultimately refer to a situation of non-demarcation of boundaries which is characterized by a spatio-temporal blur between care and research.Cette recherche doctorale en sociologie a eu pour objectif de suivre le déploiement du Plan France Médecine Génomique 2025 (PFMG 2025) à partir de l'étude d’un de ses projets pilotes en cancérologie, l’essai clinique VERYSARC. Dans le contexte de la médecine de précision, ces types d’essais ont pour objectif de tester l'intégration du séquençage des génomes à haut-débit (NGS) dans la routine du soin. En nous appuyant sur une méthodologie qualitative (entretiens et observation participante) nourrie par la sociologie des sciences et de la santé, l'enquête questionne les frontières entre soin et recherche. L’incorporation de l’essai dans le Plan s’est faite au travers d’un processus de transformation des objectifs initiaux de l’essai. Dans le cadre de cette transformation, l’essai est mobilisé dans diverses rhétoriques technoscientifiques à destination de publics différents (patients, chercheurs, acteurs politiques). Ceci dit, les promesses ne sont pas détachées de la réalité concrète de l’essai qui reste pour la majorité des acteurs du monde hospitalier un grand instrument de recherche défini par une grande complexité organisationnelle. À l’échelle du CLCC, la mise en place de l’essai met en lumière des dysfonctionnements organisationnels. Malgré une longue sociohistoire des liens entre soin et recherche, les CLCC restent un monde social régi par et pour le soin. Les observations ont ainsi permis d’identifier des situations d’asynchronie, malgré l’existence d’un cadre organisationnel dédié à la coordination, qui renvoient encore une fois à la question des frontières entre soin et recherche. Cette complexité est également visible dans les rapports entretenus par les patients inclus dans l’essai. Nous avons identifié des phénomènes d’ignorance, de déficit informationnel et d’illusion thérapeutique. Nous concluons que toutes ces explications renvoient finalement à une situation de non-démarcation des frontières qui est caractérisée par un flou spatio-temporel entre soin et recherche

Implementing precision medicine through a clinical trial : the case of the oncology pilot project of the France Genomic Medicine 2025 plan

Cette recherche doctorale en sociologie a eu pour objectif de suivre le déploiement du Plan France Médecine Génomique 2025 (PFMG 2025) à partir de l'étude d’un de ses projets pilotes en cancérologie, l’essai clinique VERYSARC. Dans le contexte de la médecine de précision, ces types d’essais ont pour objectif de tester l'intégration du séquençage des génomes à haut-débit (NGS) dans la routine du soin. En nous appuyant sur une méthodologie qualitative (entretiens et observation participante) nourrie par la sociologie des sciences et de la santé, l'enquête questionne les frontières entre soin et recherche. L’incorporation de l’essai dans le Plan s’est faite au travers d’un processus de transformation des objectifs initiaux de l’essai. Dans le cadre de cette transformation, l’essai est mobilisé dans diverses rhétoriques technoscientifiques à destination de publics différents (patients, chercheurs, acteurs politiques). Ceci dit, les promesses ne sont pas détachées de la réalité concrète de l’essai qui reste pour la majorité des acteurs du monde hospitalier un grand instrument de recherche défini par une grande complexité organisationnelle. À l’échelle du CLCC, la mise en place de l’essai met en lumière des dysfonctionnements organisationnels. Malgré une longue sociohistoire des liens entre soin et recherche, les CLCC restent un monde social régi par et pour le soin. Les observations ont ainsi permis d’identifier des situations d’asynchronie, malgré l’existence d’un cadre organisationnel dédié à la coordination, qui renvoient encore une fois à la question des frontières entre soin et recherche. Cette complexité est également visible dans les rapports entretenus par les patients inclus dans l’essai. Nous avons identifié des phénomènes d’ignorance, de déficit informationnel et d’illusion thérapeutique. Nous concluons que toutes ces explications renvoient finalement à une situation de non-démarcation des frontières qui est caractérisée par un flou spatio-temporel entre soin et recherche.This doctoral research in the field of sociology aimed to follow the deployment of the France Genomic Medicine Plan 2025 (PFMG 2025) based on the study of one of its pilot project in oncology, the VERYSARC clinical trial. In the context of precision medicine, these types of trials aim to test the integration of high-throughput genome sequencing (NGS) into routine care. Drawing on a qualitative methodology (interviews and participant observation) informed by the sociology of science and health, the investigation questions the boundaries between care and research. The incorporation of the trial into the Plan was done through a process of transformation of the initial objectives of the trial. As part of this transformation, the essay is mobilized in various technoscientific rhetorics aimed at different audiences (patients, researchers, political actors). That said, the promises are not detached from the concrete reality of the trial which remains for the majority of players in the hospital world a major research instrument defined by great organizational complexity. At the CLCC level, the implementation of the trial highlights organizational dysfunctions. Despite a long socio-history of links between care and research, CLCCs remain a social world governed by and for care. The observations thus made it possible to identify situations of asynchrony, despite the existence of an organizational framework dedicated to coordination, which once again raise the question of the boundaries between care and research. This complexity is also visible in the relationships maintained by the patients included in the trial. We have identified phenomena of ignorance, information deficit and therapeutic illusion. We conclude that all these explanations ultimately refer to a situation of non-demarcation of boundaries which is characterized by a spatio-temporal blur between care and research

Médecine de précision et inégalités sociales d’accès aux essais précoces en cancérologie

Depuis dix ans, le développement de la médecine de précision bouscule la prise en charge du cancer. Pour autant, ces nouveaux traitements restent essentiellement disponibles via la participation à des essais cliniques. Cet article s’intéresse donc aux inégalités sociales d’accès aux essais précoces en cancérologie, question jusque-là peu investiguée. Ce travail s’appuie sur une méthodologie mixte associant données qualitatives (entretiens semi-directifs et observations) et quantitatives (enquête nationale auprès de 1 355 patients inclus). L’analyse croisée de ces données met au jour l’existence d’inégalités d’ordre social (genre), organisationnel (parcours de soin) et géographique. Ces inégalités s’illustrent dès les premières étapes de la prise en charge autour de trois mécanismes : l’organisation des filières d’accès aux essais, le tri des patients en amont de l’inclusion et les contraintes liées à la participation à un protocole de recherche

Public perceptions of the association between drug effectiveness and drug novelty in France during the COVID-19 pandemic

Objectives: During the coronavirus disease 2019 (COVID-19) pandemic, public debates overtly addressed the promises of new innovative drugs. Many of these debates pitted those who advocated for the development of new drugs by pharmaceutical companies against those who favored the repositioning of existing drugs. Our study explored perceptions of the association between drug novelty and effectiveness as well as perceptions of the role of the pharmaceutical industry in drug development.Methods: Data were collected in January 2021 from a quota sample of the French population aged 18-75years (n=1,000) during the second round of the "Health Literacy Survey 2019" (HLS19).Results: We tested the hypothesis that individuals with a high level of familiarity with the health care system and those with a high level of trust in institutions are more likely to agree that new drugs are more effective than old ones and that drug development should be driven by the pharmaceutical industry. A quarter (25%) of respondents agreed that new drugs are always more effective than old ones. Agreement with this statement was stronger among respondents with a high level of familiarity with the health care system (as measured by the navigational health literacy score, OR 3.34 [2.13-5.24]). Respondents with a low level of trust in pharmaceutical companies or politicians were two times less likely to agree that new drugs are always more effective than old ones (OR 0.63 [0.42-0.95] and OR 0.68 [0.49-0.94], respectively). A high level of trust in pharmaceutical companies was reported by 42% of respondents, and 43% agreed that drug development should be driven by the pharmaceutical industry.Conclusion: Our study shows that the perceived effectiveness of innovative drugs is associated with familiarity with the health care system and trust in institutions

Public perceptions of the association between drug effectiveness and drug novelty in France during the COVID-19 pandemic

During the COVID-19 pandemic, public debates overtly addressed the promises of new innovative treatments. Many of these debates pitted those who advocated for the development of new treatments by pharmaceutical companies against those who favored the repositioning of existing drugs. Our study explored perceptions of the association between drug novelty and effectiveness as well as perceptions of the role of the pharmaceutical industry in drug development. Data were collected in January 2021 from a quota sample of the French population aged 18–75 years (N = 1,000) during the second round of the “Health Literacy Survey 2019” (HLS19). We tested the hypothesis that individuals with a high level of familiarity with the health care system and those with a high level of trust in institutions are more likely to agree that new drugs are more effective than old ones and that drug development should be driven by the pharmaceutical industry. A quarter (25%) of respondents agreed that new drugs are always more effective than old ones. Agreement with this statement was stronger among respondents with a high level of familiarity with the health care system (as measured by the Navigational Health Literacy score, OR 3.34 [2.13-5.24]) and among those with a high level of trust in pharmaceutical companies or politicians. A high level of trust in pharmaceutical companies was reported by 42% of respondents, and 43% agreed that drug development should be driven by the pharmaceutical industry. Respondents who agreed that new drugs are always more effective than old ones were almost four times more likely to agree that drug development should be driven by the pharmaceutical industry (OR 3.85 [2.76-5.39]). A better understanding of public attitudes towards new treatments is needed to elucidate individual preferences in health care and their consequences on health behavior

Public perceptions of the association between drug effectiveness and drug novelty in France during the COVID-19 pandemic

During the COVID-19 pandemic, public debates overtly addressed the promises of new innovative treatments. Many of these debates pitted those who advocated for the development of new treatments by pharmaceutical companies against those who favored the repositioning of existing drugs. Our study explored perceptions of the association between drug novelty and effectiveness as well as perceptions of the role of the pharmaceutical industry in drug development. Data were collected in January 2021 from a quota sample of the French population aged 18–75 years (N = 1,000) during the second round of the “Health Literacy Survey 2019” (HLS19). We tested the hypothesis that individuals with a high level of familiarity with the health care system and those with a high level of trust in institutions are more likely to agree that new drugs are more effective than old ones and that drug development should be driven by the pharmaceutical industry. A quarter (25%) of respondents agreed that new drugs are always more effective than old ones. Agreement with this statement was stronger among respondents with a high level of familiarity with the health care system (as measured by the Navigational Health Literacy score, OR 3.34 [2.13-5.24]) and among those with a high level of trust in pharmaceutical companies or politicians. A high level of trust in pharmaceutical companies was reported by 42% of respondents, and 43% agreed that drug development should be driven by the pharmaceutical industry. Respondents who agreed that new drugs are always more effective than old ones were almost four times more likely to agree that drug development should be driven by the pharmaceutical industry (OR 3.85 [2.76-5.39]). A better understanding of public attitudes towards new treatments is needed to elucidate individual preferences in health care and their consequences on health behavior

Public perceptions of the association between drug effectiveness and drug novelty in France during the COVID-19 pandemic

During the COVID-19 pandemic, public debates overtly addressed the promises of new innovative treatments. Many of these debates pitted those who advocated for the development of new treatments by pharmaceutical companies against those who favored the repositioning of existing drugs. Our study explored perceptions of the association between drug novelty and effectiveness as well as perceptions of the role of the pharmaceutical industry in drug development. Data were collected in January 2021 from a quota sample of the French population aged 18–75 years (N = 1,000) during the second round of the “Health Literacy Survey 2019” (HLS19). We tested the hypothesis that individuals with a high level of familiarity with the health care system and those with a high level of trust in institutions are more likely to agree that new drugs are more effective than old ones and that drug development should be driven by the pharmaceutical industry. A quarter (25%) of respondents agreed that new drugs are always more effective than old ones. Agreement with this statement was stronger among respondents with a high level of familiarity with the health care system (as measured by the Navigational Health Literacy score, OR 3.34 [2.13-5.24]) and among those with a high level of trust in pharmaceutical companies or politicians. A high level of trust in pharmaceutical companies was reported by 42% of respondents, and 43% agreed that drug development should be driven by the pharmaceutical industry. Respondents who agreed that new drugs are always more effective than old ones were almost four times more likely to agree that drug development should be driven by the pharmaceutical industry (OR 3.85 [2.76-5.39]). A better understanding of public attitudes towards new treatments is needed to elucidate individual preferences in health care and their consequences on health behavior