Knowledge Discovery on Clinical Trials to Explore the Overall Safety of the Medicinal Produ.pdf

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2017-04-06 发布于江苏
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Knowledge Discovery on Clinical Trials to Explore the Overall Safety of the Medicinal Produ.pdf

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Knowledge Discovery on Clinical Trials to Explore the Overall Safety of the Medicinal Produ

Knowledge Discovery on Clinical Trials to Explore the Overall Safety of the Medicinal Products. A case study. Vincent HUPERTAN, Université Lyon2, 39 rue de Verdun, 78110 Le Vésinet cedex France, 3.89.01, vhupertan@wanadoo.fr Nicolas DELTOUR, I.R.I.SERVIER, 6 place des Pléiades, 92415 Courbevoie-France, 2.36.20, nicolas.deltour@ Jean-Hugues CHAUCHAT, Université Lyon2, ERIC, 5 avenue Pierre MENDES-FRANCE, 69676 Lyon- BRON; France, 7.23.79, chauchat@univ-lyon2.fr Maylis COSTE, I.R.I.SERVIER, 6 place des Pléiades, 92415 Courbevoie, France, 2.61.50, maylis.coste@ Hervé MIGNOT, SPSS France, 20, avenue André Prothin,, 92927 Paris- La-Défense Cedex France, 7.36.00, hmignot@ ABSTRACT Aims: We propose a methodological framework for the use of the Knowledge Discovery Process to improve knowledge on the safety of medicinal products, to enhance the performance of the integrated safety summaries (ISS). Backgroud: With regard to safety, it is important to show that the drug is not harmful under the intended conditions of use for any patient in the target population. The “integrated safety report” is as part of the New Drug Application file submitted to health authorities in accord with the regulatory guidelines. For this reason, data from multiple clinical trials are pooled, and safety- related data are summarized as: 1) extent of exposure, 2) common adverse events (AE) and changes in laboratory results, 3) significant AE. Combining trials increases the probability of detecting rare AE or an isolated signal, allows more precise estimation of treatment effect, and allows the impact of additional variables to be evaluated because of the increased precision. Based on CRISP-Data Mining methodology, we propose a global framework with defined 3 different strategies: to enhance the knowledge of a drug – specific AE relationship, to discover hidden patterns on data from a overall safety perspective and the must alluring is to detect specific signals anticipatin