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Patient Engagement at a Tipping Point-The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, "Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products".
Smith MY, Hammad TA, Metcalf M, Levitan B, Noel R, Wolka AM, Michaels DL, Johnson FR. Smith MY, et al. Among authors: metcalf m. Ther Innov Regul Sci. 2016 Sep;50(5):546-553. doi: 10.1177/2168479016662902. Ther Innov Regul Sci. 2016. PMID: 30231755
Recommendations for benefit-risk assessment methodologies and visual representations.
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. Hughes D, et al. Pharmacoepidemiol Drug Saf. 2016 Mar;25(3):251-62. doi: 10.1002/pds.3958. Epub 2016 Jan 22. Pharmacoepidemiol Drug Saf. 2016. PMID: 26800458 Free article.
Recognizing that Evidence is Made, not Born.
Lim R, Lee DK, Sabourin P, Ferguson J, Metcalf M, Smith M, Corriol-Rohou S, Eichler HG, Lumpkin M, Hirsch G, Chen IM, O'Rourke B, Schiel A, Crabb N, Aronson N, Pezalla E, Boutin M, Binder L, Wilhelm L. Lim R, et al. Among authors: metcalf m. Clin Pharmacol Ther. 2019 Apr;105(4):844-856. doi: 10.1002/cpt.1317. Epub 2019 Jan 4. Clin Pharmacol Ther. 2019. PMID: 30472743 Free PMC article.
Balancing benefit and risk of medicines: a systematic review and classification of available methodologies.
Mt-Isa S, Hallgreen CE, Wang N, Callréus T, Genov G, Hirsch I, Hobbiger SF, Hockley KS, Luciani D, Phillips LD, Quartey G, Sarac SB, Stoeckert I, Tzoulaki I, Micaleff A, Ashby D; IMI-PROTECT benefit-risk participants. Mt-Isa S, et al. Pharmacoepidemiol Drug Saf. 2014 Jul;23(7):667-78. doi: 10.1002/pds.3636. Epub 2014 May 13. Pharmacoepidemiol Drug Saf. 2014. PMID: 24821575 Review.
Benefit-risk assessment in a post-market setting: a case study integrating real-life experience into benefit-risk methodology.
Hallgreen CE, van den Ham HA, Mt-Isa S, Ashworth S, Hermann R, Hobbiger S, Luciani D, Micaleff A, Thomson A, Wang N, van Staa TP, Downey G, Hirsch I, Hockley K, Juhaeri J, Metcalf M, Mwangi J, Nixon R, Peters R, Stoeckert I, Waddingham E, Tzoulaki I, Ashby D, Wise L. Hallgreen CE, et al. Among authors: metcalf m. Pharmacoepidemiol Drug Saf. 2014 Sep;23(9):974-83. doi: 10.1002/pds.3676. Epub 2014 Jul 5. Pharmacoepidemiol Drug Saf. 2014. PMID: 25043919 Free article.
281 results