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Master Thesis

Utilisation des données de vie réelle dans l’évaluation du médicament : exemple dans le myélome multiple

Abstract : A multitude of data is available today throughout the patient care process. This wealth of information on the conditions of prescription, use of products and their tolerance profile represents an opportunity to continuously improve and develop the quality of care and knowledge of the pathologies. Multiple myeloma is an hematological cancer that remains incurable to this day and affects 5,000 new people per year in France. Research in this sector is active because it is an unmet therapeutic need with many options to be explored in a context of development of living innovation and targeted therapies. Clinical studies are essential to demonstrate the efficacy of a treatment and to obtain its marketing authorization. However, their strict methodology does not always allow them to be representative of the populations treated in multiple myeloma. Medico-administrative databases such as the Health Data Hub, real-life databases from private companies, and the VigiBase global pharmacovigilance database allow for the centralization of real-life data collection. This thesis cites different applications and analysis of these data and what they contribute to the management and knowledge of treatments in multiple myeloma. It also discusses the ethical and patient safety issues that these practices may raise.
Document type :
Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03479734
Contributor : Jean-Hugues Morneau Connect in order to contact the contributor
Submitted on : Tuesday, December 14, 2021 - 2:42:05 PM
Last modification on : Thursday, December 16, 2021 - 3:32:27 AM
Long-term archiving on: : Tuesday, March 15, 2022 - 7:11:04 PM

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  • HAL Id : dumas-03479734, version 1
  • PPN : 259082074

Citation

Barbara Chazot. Utilisation des données de vie réelle dans l’évaluation du médicament : exemple dans le myélome multiple. Sciences pharmaceutiques. 2021. ⟨dumas-03479734⟩

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