Literature DB >> 28199180

Marketing Authorization Procedures for Advanced Cancer Drugs: Exploring the Views of Patients, Oncologists, Healthcare Decision Makers, and Citizens in France.

Christel Protiére1,2,3,4, Rachel Baker4, Dominique Genre5, Anthony Goncalves6, Patrice Viens6.   

Abstract

BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.

Entities:  

Keywords:  Q-methodology, advanced cancer; efficacy criteria; health policy; marketing authorization; societal perspectives

Mesh:

Substances:

Year:  2017        PMID: 28199180     DOI: 10.1177/0272989X17691953

Source DB:  PubMed          Journal:  Med Decis Making        ISSN: 0272-989X            Impact factor:   2.583


  4 in total

Review 1.  Patients' understanding of oncology clinical endpoints: A literature review.

Authors:  Vanessa Boudewyns; Brian G Southwell; Jessica T DeFrank; Kate Ferriola-Bruckenstein; Michael T Halpern; Amie C O'Donoghue; Helen W Sullivan
Journal:  Patient Educ Couns       Date:  2020-03-20

2.  Patterns of patient and healthcare provider viewpoints regarding participation in HIV cure-related clinical trials. Findings from a multicentre French survey using Q methodology (ANRS-APSEC).

Authors:  Christel Protière; Bruno Spire; Marion Mora; Isabelle Poizot-Martin; Marie Préau; Marjolaine Doumergue; Philippe Morlat; David Zucman; Cécile Goujard; François Raffi; Olivier Lambotte; Marie Suzan-Monti
Journal:  PLoS One       Date:  2017-11-02       Impact factor: 3.240

3.  Old drug, new clinical use, no man's land for the indication: an awareness call from European experts.

Authors:  Stefan Rauh; Leonidas Mavroeidis; Panagiotis Ntellas; Ioanna Gazouli; Stefania Gkoura; Alexandra Papadaki; Davide Mauri; Yannis Metaxas; Jean-Yves Douillard; George Pentheroudakis
Journal:  ESMO Open       Date:  2020-09-30

4.  A scoping review of Q-methodology in healthcare research.

Authors:  Kate Churruca; Kristiana Ludlow; Wendy Wu; Kate Gibbons; Hoa Mi Nguyen; Louise A Ellis; Jeffrey Braithwaite
Journal:  BMC Med Res Methodol       Date:  2021-06-21       Impact factor: 4.615

  4 in total

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