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Décision de participer à un essai clinique en cancérologie: influence du vécu sur les attitudes

Decision-making and participation in clinical trials

  • Essai Clinique
  • Published:
Oncologie

Résumé

L’objectif de cette étude était de comparer les attitudes théoriques par rapport à la participation ou non à un essai randomisé contrôlé (ERC) de trois groupes comparables de patientes suivies prospectivement (cancer du sein non métastatique traité par chimiothérapie standard): ayant eu une proposition de participer à un ERC (201 acceptations, 66 refus) ou pas (n = 188). Le refus de participer semble être une décision personnelle, alors que le souhait reflète davantage l’approbation de la proposition du médecin. Lors de la proposition de participation, les médecins doivent faire face à une aversion envers le procédé de randomisation et discuter abondamment des raisons et de l’importance de la randomisation ainsi que de tous les aspects de la participation à un ERC afin de transmettre aux patients toute l’information nécessaire pour prendre une décision informée.

Abstract

The aim of this study was to compare, theoretically, attitudes towards participating or declining to participate in a hypothetical randomized controlled trial (RCT) involving three comparable breast cancer patient groups surveyed prospectively (non-metastatic cancer treated with standard chemotherapy): some patients were invited to participate in the clinical RCT (201 acceptances, 66 refusals) and others were not (n = 188). Patients’ acceptance to participate reflected their physicians’ approval, whereas refusal was usually a personal choice. When proposing RCTs, physicians must address patients’ negative preconceptions about randomization. Physicians should thoroughly discuss the reasons for and importance of randomization as well as the other aspects of participating in clinical trials in order to provide patients with all the information they need to make informed decisions.

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Author information

Authors and Affiliations

  1. Inserm, UMR379, épidémiologie et sciences sociales appliquées à l’innovation médicale, institut Paoli-Calmettes, F-13273, Marseille, France

    J. Mancini & C. Julian-Reynier

  2. Faculté de médecine, université d’Aix-Marseille, Lertim, F-13385, Marseille, France

    J. Mancini

  3. Assistance publique-Hôpitaux de Marseille, hôpital de La Timone, SSPIM, F-13385, Marseille, France

    J. Mancini

  4. Fédération nationale des centres de lutte contre le cancer (FNCLCC), F-75654, Paris, France

    J. Genève & M. Jimenez

  5. Institut Claudius-Regaud, F-31052, Toulouse, France

    F. Dalenc & H. Roché

  6. Institut Paoli-Calmettes, F-13273, Marseille, France

    D. Genre & C. Tarpin

  7. Centre André-Boulloche, F-25209, Montbéliard, France

    A. Monnier

  8. Centre Eugène-Marquis, F-35042, Rennes, France

    P. Kerbrat

  9. Centre Antoine-Lacassagne, F-06189, Nice, France

    R. Largillier

  10. Institut Sainte-Catherine, F-84082, Avignon, France

    D. Serin

  11. Centre Alexis-Vautrin, F-54511, Vandoeuvre-lès-Nancy, France

    M. Rios

Authors
  1. J. Mancini
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  2. J. Genève
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  3. F. Dalenc
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  4. D. Genre
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  5. A. Monnier
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  6. P. Kerbrat
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  7. R. Largillier
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  8. D. Serin
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  9. M. Rios
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  10. H. Roché
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  11. M. Jimenez
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  12. C. Tarpin
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  13. C. Julian-Reynier
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Ie Comité de patients de la Ligue nationale contre le cancer

Corresponding author

Correspondence to C. Julian-Reynier.

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Mancini, J., Genève, J., Dalenc, F. et al. Décision de participer à un essai clinique en cancérologie: influence du vécu sur les attitudes. Oncologie 10, 149–154 (2008). https://doi.org/10.1007/s10269-007-0827-6

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  • DOI: https://doi.org/10.1007/s10269-007-0827-6

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