PUBLICATIONS

1. Hughes D., Waddingham E., Mt-Isa S., Goginsky A., Chan E., Downey GF., Hallgreen C.E., Hockley K.S., Juhaeri J., Lieftucht A., Metcalf M.A., Noel R.A., Phillips L.D., Ashby D., Micaleff A., on behalf of the PROTECT Benefit-Risk Group. 2016. Recommendations for benefit-risk assessment methodologies and visual representations. Pharmacoepidemiol Drug Saf. DOI: 10.1002/pds.3958.

2. Hallgreen C.E., Mt-Isa S., Lieftucht A., Phillips L.D., Hughes D., Talbot S., Asiimwe A., Downey G., Genov G., Hermann R., Noel R., Peters R., Micaleff A., Tzoulaki I., Ashby D, on behalf of the PROTECT Benefit-Risk group. 2015. Literature review of visual representation of the results of benefit-risk assessments of medicinal products. Pharmacoepidemiol Drug Saf. DOI: 10.1002/pds.3880.

3. Nixon, R., Dierig, C., Mt-Isa, S., Stoeckert, I., Tong, T., Kuhls, S., Hodgson, G., Pears, J., Waddingham, E., Hockley, K., Thomson, A., and on behalf of the IMI-PROTECT Benefit-Risk Group. 2014. A case study using the PrOACT-URL and BRAT frameworks for structured benefit-risk assessment. Biometrical Journal, DOI: 10.1002/bimj.201300248.

4. Waddingham, E., Mt-Isa, S., Nixon, R., Ashby, D., and on behalf of the IMI-PROTECT Benefit-Risk Group. 2014. A Bayesian approach to probabilistic sensitivity analysis in structured benefit-risk assessment. Biometrical Journal, DOI: 10.1002/bimj.201300254.

5. 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.P., Wise, L., and on behalf of the IMI-PROTECT Benefit-Risk Group. 2014. Benefit-risk assessment in a post-market setting: A case study integrating real-life experience into benefit-risk methodology. Pharmacoepidemiology and Drug Safety, 23(9):974-83.

6. Mt-Isa, S., Hallgreen, C.E., Wang, N., Callreus, T., Genov, G., Hirsch, I., Hobbiger, S.F., Hockley, K.S., Luciani, D., Phillips, L.D., Quartey, G., Sarac, S.B., Stoeckert, I., Tzoulaki, I., Micaleff, A., Ashby, D., and on behalf of the IMI-PROTECT Benefit-Risk participants. 2014. Balancing benefit and risk of medicines: a systematic review and classification of available methodologies. Pharmacoepidemiology and Drug Safety, 23(7):667-78.