BENEFIT-RISK INTEGRATION AND REPRESENTATION

PUBLICATIONS

• Hallgren CE, Mt-Isa S, Lieftucht A et al. PROTECT Benefit-Risk group. Literature review of visual representation of the results of benefit-risk assessments of medicinal products - Pharmacoepidemiol Drug Safety, March 2016 ;25(3):238-50.

 

• Hallgreen C.E., Van den Ham H.A., Mt-Isa S., Ashworth S., Hermann R., Hobbiger S., Luciani D., Micaleff A., Thomson A., Wang N., Van Staa T., Wise L., and on behalf of IMI-PROTECT Benefit-Risk Group - Benefit-risk assessment in a post-market setting: A case study integrating real-life experience into benefit-risk methodology, Pharmacoepidemiology and Drug Safety, September 2014.

 

• Hughes D, Waddingham E, Mt-Isa S, Goginsky A, Chan E, Downey GF, Hallgreen CE, Hockley KS, Juhaeri J, Lieftucht A, Metcalf MA, Noel RA, Phillips LD, Ashby D, Micaleff A; PROTECT Benefit-Risk Group - Recommendations for benefit-risk assessment methodologies and visual representations. Pharmacoepidemiol Drug Safety. 2016;25(3):251-62. doi: 10.1002/pds.3958. Epub January 2016.

 

• Mt-Isa S, Hallgreen C.E., Wang N., Callréus T., Genov G., Hirsch I., Hobbiger S., Hockley .S., Luciani D., Phillips L.D., Quartey G., Sarac S.B., Stoeckert I., Tzoulaki I., Micaleff A., Ashby D.- Balancing benefit and risk of medicines a systematic review and classification of available methodologies, Pharmacoepidemiology and Drug Safety, May 2014

 

• Nixon R., Dierig C., Mt-Isa S., Stöckert I., Tong T., Kuhls S., Hodgson G., Pears J., Waddingham E., Hockley K., Thomson A. - A case study comparing the BRAT and PROACT-URL framework for benefit risk assessment, Biometrical Journal, January 2015.

 

• Waddingham E., Mt-Isa S., Nixon R., Ashby D., and on behalf of IMI-PROTECT Benefit-Risk Group - A Bayesian approach to probabilistic sensitivity analysis in structured benefit-risk assessment, Biometrical Journal, January 2015.

 

 

 

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