CIC 1406 - Grenoble

Who are we ?

The Grenoble Clinical Investigation Center (Inserm CIC1406, coordinated by Pr Alexandre Moreau-Gaudry) comprises two modules, the multi-thematic module (coordinated by Pr Matthieu Roustit) and the module in innovative technologics (coordinated by Pr Alexandre Moreau-Gaudry). The multi-thematic module is developing part of its research on innovative methodologies in clinical research and pharmacoepidemiology, led by Pr Matthieu Roustit and Dr Charles Khouri.

Topics of interest

• Individual randomized trials (n-of-1) (Roustit, Ann Intern Med 2018; Giai, Stat in Med 2023)
• Externally controlled trials (Cucherat, Therapie 2020; Larrouquere, CPT 2020)
• Analysis of disproportionality signals (Renoud, JAMA Intern Med 2021; Khouri, JCE 2021a; Mouffak, JCE 2021; Khouri, JCE 2021b)
• Platform trials (Roustit, Therapie 2022)
• Placebo response (Roustit, Semin Arthritis Rheum 2022)

Main publications

• Giai J, Péron J, Roustit M, Cracowski JL, Roy P, Ozenne B, Buyse M, Maucort-Boulch D. Individualized Net Benefit estimation and meta-analysis using generalized pairwise comparisons in N-of-1 trials. Stat Med. 2023 Jan 3. doi: 10.1002/sim.9648.
• Roustit M, Demarcq O, Laporte S, Barthélémy P, Chassany O, Cucherat M, Demotes J, Diebolt V, Espérou H, Fouret C, Galaup A, Gambotti L, Gourio C, Guérin A, Labruyère C, Paoletti X, Porcher R, Simon T, Varoqueaux N. Platform trials. Therapie. 2022 Dec 5:S0040-5957(22)00277-3
• Roustit M, Jullien A, Jambon-Barbara C, Goudon H, Blaise S, Cracowski JL, Khouri C. Placebo response in Raynaud's Phenomenon clinical trials: The prominent role of regression towards the mean. Semin Arthritis Rheum. 2022 Dec;57:152087.
• Renoud L, Khouri C, Revol B, Lepelley M, Perez J, Roustit M, Cracowski JL. Association of Facial Paralysis With mRNA COVID-19 Vaccines: A Disproportionality Analysis Using the World Health Organization Pharmacovigilance Database.  JAMA Intern Med. 2021 Sep 1;181(9):1243-1245.
• Khouri C, Petit C, Tod M, Lepelley M, Revol B, Roustit M, Cracowski JL. Adverse drug reaction risks obtained from meta-analyses and pharmacovigilance disproportionality analyses are correlated in most cases. J Clin Epidemiol. 2021 Jun;134:14-21.
• Mouffak A, Lepelley M, Revol B, Bernardeau C, Salvo F, Pariente A, Roustit M, Cracowski JL, Khouri C. High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study. J Clin Epidemiol. 2021 Oct;138:73-79
• Khouri C, Revol B, Lepelley M, Mouffak A, Bernardeau C, Salvo F, Pariente A, Roustit M, Cracowski JL.A meta-epidemiological study found lack of transparency and poor reporting of disproportionality analyses for signal detection in pharmacovigilance databases. J Clin Epidemiol. 2021 Nov;139:191-198.
• Roustit M, Giai J, Gaget O, Khouri C, Mouhib M, Lotito A, Blaise S, Seinturier C, Subtil F, Paris A, Cracowski C, Imbert B, Carpentier P, Vohra S, Cracowski JL. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials. Ann Intern Med. 2018 Nov 20;169(10):694-703.
• Larrouquere L, Giai J, Cracowski JL, Bailly S, Roustit M. Externally Controlled Trials: Are We There Yet? Clin Pharmacol Ther. 2020 Nov;108(5):918-919.
• Cucherat M, Laporte S, Delaitre O, Behier JM; participants of Giens XXXV Round Table Clinical Research; d'Andon A, Binlich F, Bureau S, Cornu C, Fouret C, Hoog Labouret N, Laviolle B, Miadi-Fargier H, Paoletti X, Roustit M, Simon T, Varoqueaux N, Vicaut E, Westerloppe J. From single-arm studies to externally controlled studies. Methodological considerations and guidelines. Therapie. 2020 Jan-Feb;75(1):21-27.