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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Value of post-registration studies for reimbursement renewal; [Études post-AMM: Apport dans la réinscription des produits]
Therapie, Volume 64, No. 3, Year 2009
Notification
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Description
Post-registration studies describe parameters of real-life clinical practice such as the treated population, conditions of treatment initiation, treatment duration, adherence, associated benefits/risks as well as the impact on treatment strategies, healthcare procedures and on public health. The results of these studies are used in particular for re-evaluation, re-registration or in applications for reimbursement. Since 1997, 134 requests for post-registration studies have been made either by the French Transparency Committee (CT) and/or the Committee for Pricing of Healthcare Products (CEPS) and the results of these studies were taken into account in the re-evaluation of Actual Benefit (AB) or Improvement in Actual Benefit (IAB). During the roundtable discussion on this subject at the National Clinical Pharmacology Meeting held at Giens (France), the difficulties in performing such studies were identified and proposals were made to predict and anticipate requests for these studies but also for the training of physicians. © 2009 Société Française de Pharmacologie et de Thérapeutique.
Authors & Co-Authors
Molimard, Mathieu
France, Talence
Centre Hospitalier Universitaire de Bordeaux
France, Bordeaux
Groupe Hospitalier Pellegrin
Vray, Muriel M.
France, Paris
Institut Pasteur, Paris
Blin, Patrick
France, Bordeaux
Université de Bordeaux
Girault, Danièle
Unknown Affiliation
Hamers, Françoise F.
Unknown Affiliation
Pathak, Atul
France, Toulouse
Université Toulouse Iii - Paul Sabatier
Statistics
Citations: 3
Authors: 6
Affiliations: 15
Identifiers
Doi:
10.2515/therapie/2009029
ISSN:
00405957
Research Areas
Health System And Policy
Study Design
Cross Sectional Study