Studies Case & Publications

MDSTAT Consulting Studies Cases & Publications

Généthon

Généthon

Methodology, choice of design and writing of a procedure of First in Man - pivotal, gene-therapy study in children with Duchenne Muscular Dystrophy. Discussions with Regulatory agencies (EMA/FDA)

IPSEN

IPSEN SMECTA ®

Participation in writing, choice of designs, within the framework of protocols for extensions of Smecta indication (new countries, new indications, new form of administration).

SANTEN

SANTEN IKERVIS ®

Biostatistics support (main biostatistician) throughout the development program (phases II - dose selection, phases III - demonstration of efficiency, participation in advices and support for submission to EMA).
Creation of a composite criterion combining the signs and symptoms of the pathology.
Obtaining the MMA from the European Commission on 03/25/2015 (first cyclosporine authorized in this context). Participation in scientific publications.

CEVA Santé Animale

CEVA Santé Animale VECTRA 3D ®

Assessing of the effectiveness of antiparasitics drugs for dog caused by an infection due to mosquitoes. Development of the methodology for statistical analysis of the experimental plan, results interpretation.

ETHYPHARM

ETHYPHARM Baclofène ®

Biostatistics assistance for the analysis of the 2 French confirmatory clinical trials. Statistical methodology, in particular on missing data imputation. Participation in the development of the dossier with the ANSM (French National Agency for the safety of medicines and Health products).

Publications

  • Avril 2020

    Journal of Market Access Health and Policy › Clinical efficacy assessment in severe vernal keratoconjunctivitis: preliminary validation of a new penalties-adjusted corneal fluorescein staining score

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  • Mai 2017

    PSI Conference 2017 › Use of a composite criterion taking into account rescue medication intake in an orphan disease with a seasonal pattern

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  • Avril 2017

    Invest Ophthalmol Vis Sci › Correlation Between the Inflammatory Marker HLA-DR and Signs and Symptoms in Moderate to Severe Dry Eye Disease.

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  • 2015

    Veterinary Record › Dog-appeasing pheromone collars reduce sound-induced fear and anxiety in beagle dogs: a placebo-controlled study

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  • Juin 2015

    ARVO Annual Meeting Abstract › Correlation between the Inflammatory Marker HLA DR and Signs and Symptoms in moderate to severe Dry Eye Disease

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  • Novembre 2013

    Contraception › Ulipristal acetate prevents ovulation more effectively than levonorgestrel: analysis of pooled data from three randomized trials of emergency contraception regimens.

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