Contribution of Modeling Approaches and Virtual Populations in Transposing the Results of Clinical Trials into Real Life and in Enlightening Public Health Decisions

¹ Clinical Pharmacology and Therapeutic Trials, Hospices Civils de Lyon, France & UMR5558, CNRS and Lyon 1 University, Lyon France
² Global Medical Affairs, Sanofi R&D, Chilly-Mazarin, France
³ National Conservatory of Arts and Crafts, Paris, France
⁴ PhiSquare, Paris, France
⁵ CIC-P 0005 Pharmacology Service, Bordeaux Segalen University, Bordeaux, France
⁶ Phisquare, Transplant Fondation, Paris, France ; University Hospital of Besançon, Saint Jacques Hospital, Besançon, France

Correspondence and offprints: François Gueyffier, Clinical Pharmacology and Clinical Trials Service, Louis Pradel Hospital, BP Lyon Monchat, 69394 Lyon Cedex 03, France. Email: francois.gueyffier@univ-lyon1.fr

Received: 20 March 2012
Accepted: 4 June 2012

Abstract

Modeling consists in aggregating separate pieces of knowledge, according to a given structure and rules. It allows studying the behavior of more or less complex systems by simulation techniques. Modeling is used in different state-of-the-art technological domains (meteorology, aeronautics). Its use has grown for the evaluation of medicines and medical devices, from conception to prescription (marketing authorization, reimbursement, price setting and re-registrations). It follows a scientific approach and is the object of good practice recommendations. Coupling models to virtual populations allows obtaining realistic results at the population level, testing diagnostic or therapeutic strategies, as well as estimating the consequences of transposing the results of clinical trials to the population. Through examples, the participants of the Round Table analyzed the contributions of the coupling of models and realistic virtual populations, and proposed guidelines for their judicious and systematic use.