title: Marketing Authorization Procedures for Advanced Cancer Drugs: Exploring the Views of Patients, Oncologists, Healthcare Decision Makers, and Citizens in France.
abstract: The past decades have seen advances in cancer treatments in terms of toxicity and side effects but progress in the treatment of advanced cancer has been modest. New drugs have emerged improving progression free survival but with little impact on overall survival, raising questions about the criteria on which to base decisions to grant marketing authorizations and about the authorization procedure itself. For decisions to be fair, transparent and accountable, it is necessary to consider the views of those with relevant expertise and experience.
  
  
  
  We conducted a Q-study to explore the views of a range of stakeholders in France, involving: 54 patients (18 months after diagnosis); 50 members of the general population; 27 oncologists; 19 healthcare decision makers; and 2 individuals from the pharmaceutical industry.
  
  
  
  Three viewpoints emerged, focussing on different dimensions entitled: 1) 'Quality of life (QoL), opportunity cost and participative democracy'; 2)'QoL and patient-centeredness'; and 3) 'Length of life'. Respondents from all groups were associated with each viewpoint, except for healthcare decision makers, who were only associated with the first one.
  
  
  
  Our results highlight plurality in the views of stakeholders, emphasize the need for transparency in decision making processes, and illustrate the importance of a re-evaluation of treatments for all 3 viewpoints. In the context of advanced cancer, our results suggest that QoL should be more prominent amongst authorization criteria, as it is a concern for 2 of the 3 viewpoints.
authors.affiliation: Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France (CP).|ORS PACA, Marseille, France (CP).|Aix Marseille Univ, AMSE, Marseille, France (CP).|Yunus Centre for Social Business and Health - Glasgow Caledonian University (RB).
authors.forename: Christel
authors.initials: C
authors.lastname: Protiére
authors.affiliation: Yunus Centre for Social Business and Health - Glasgow Caledonian University (RB).
authors.forename: Rachel
authors.initials: R
authors.lastname: Baker
authors.affiliation: Institut Paoli Calmettes, Direction de la Recherche Clinique et de l'Innovation, F-13009, Marseille, France (DG).
authors.forename: Dominique
authors.initials: D
authors.lastname: Genre
authors.affiliation: Institut Paoli Calmettes, Department of Molecular Oncology, and CRCM, Inserm, U1068; Aix-Marseille Université, UM 105; CNRS, UMR7258, F-13009, Marseille, France (AG, PV).
authors.forename: Anthony
authors.initials: A
authors.lastname: Goncalves
authors.affiliation: Institut Paoli Calmettes, Department of Molecular Oncology, and CRCM, Inserm, U1068; Aix-Marseille Université, UM 105; CNRS, UMR7258, F-13009, Marseille, France (AG, PV).
authors.forename: Patrice
authors.initials: P
authors.lastname: Viens
mesh_terms: D000970:Antineoplastic Agents; D003657:Decision Making; D004345:Drug Industry / Q000458:organization & administration*; D005602:France; D006801:Humans; D040541:Marketing; D009369:Neoplasms / Q000188:drug therapy / Q000503:physiopathology; D000072103:Oncologists / Q000523:psychology*; D010361:Patients / Q000523:psychology*; D011788:Quality of Life
chemical_list: D000970:Antineoplastic Agents
keywords: Q-methodology, advanced cancer; efficacy criteria; health policy; marketing authorization; societal perspectives