Publications
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Gilsenan AW, Brainsky A, Colilla S. Applying CIRS-BRAT framework in a regulatory setting: updated benefit risk assessment for fibrinogen concentrate in the setting of complex cardiac surgery. Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):964. doi: 10.1002/pds.4864
Ritchey ME, Hollis KA, Hauber AB, Gilsenan A, Krueger WS. Reporting of "Benefit-Risk" studies for medical devices in published literature. Poster presented at the 2018 ISPOR 23rd Annual International Meeting; May 23, 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl 1):S175. doi: 10.1016/j.jval.2018.04.1167
Gilsenan A, Smith M, Wise L, Mouchantat R, Dal Pan G, Morrato E. Introduction to therapeutic risk management. Presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2017. Montreal, Canada.
Hauber AB, Gilsenan A, Juhaeri J, Zhong Y, Noel B. Benefit risk assessment: understanding and using patient preference methodologies. Presented at the 31st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2015. Boston, MA.
Gilsenan AW. European guideline on Good Pharmacovigilance Practices (GVP) – Module XVI – risk minimization measures. Presented at the SCOPE Summit for Clinical Ops Executives; February 25, 2015. Orlando, FL.
Gilsenan AW. Observational data collection studies: considerations to minimize bias. Presented at the SCOPE Summit for Clinical Ops Executives; February 24, 2015. Orlando, FL.
Freeman E, Gilsenan AW. Assess the European guideline on good pharmacovigilance practices (GVP) – module XVI – risk minimization measures. Presented at the 7th Risk Evaluation and Mitigation Strategies Summit (REMS Summit); January 22, 2015. Arlington, VA.
Andrews EB, Davis KH, DiBenedetti DB, Forsyth B, Gilsenan AW, Hollis KA, Lewis SA, Price MA, Tennis P, Zografos LJ. Risk evaluation and mitigation strategy assessments: social science methodologies to assess goals related to knowledge. 2014. Research Triangle Park: RTI Press.
Gilsenan AW, Andrews EB. Considerations and strategies for benefit-risk assessment in the real-world setting. In: Sashegyi A, Felli J, Noel R, editors. Benefit-risk assessment in pharmaceutical research and development. 1st ed. Boca Raton: United States. CRC Press; 2013. p.153-64.
Gilsenan AW, Harris DH, Midkiff KD, Andrews EB, Massica D. Seeing the big picture in long-term surveillance for rare events. Presented at the North American Association of Central Cancer Registries Annual Conference; 2013.
Chirila C, Gilligan TM, Gilsenan A, Price M, Hollis K, Calingaert B, Zografos L, Andrews E. A comparison of factors influencing patient knowledge: results across selected REMS surveys. Poster presented at the 27th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 18, 2011. Chicago, IL.
Gilsenan A, Hollis K, Zografos L, Calingaert B, Andrews E. Examination of respondent bias and patient characteristics in multiple REMS assessment surveys. Poster presented at the 27th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 18, 2011. Chicago, IL.
Mintz ML, Yawn BP, Mannino DM, Donohue JF, Hanania NA, Grellet CA, Gilsenan AW, McLeod LD, Dalal AA, Raphiou IH, Prillaman BA, Crater GD, Cicale MJ, Mapel DW. Prevalence of airway obstruction assessed by lung function questionnaire. Mayo Clin Proc. 2011 May 1;86(5):375-81.
Levitan BS, Andrews EB, Gilsenan A, Ferguson J, Noel RA, Coplan PM, Mussen F. Application of the BRAT framework to case studies: observations and insights. Clin Pharmacol Ther. 2011 Feb 1;89(2):217-24. doi: 10.1038/clpt.2010.280
Gilsenan A, Andrews E, Hollis KA. Characterization of current risk evaluation and mitigation strategies. Poster presented at the 26th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2010. Brighton, United Kingdom. [abstract] Pharmacoepidemiol Drug Saf. 2010 Aug; 19(S1):S100. doi: 10.1002/pds.2019
Andrews EB, Irish WD, Gilsenan AW, Campbell WH. Evaluation of therapeutic risk management programs. In: Hartzema AG, Tilson HH, Arnold Chan K, editors. Pharmacoepidemiology and therapeutic risk management. 1st ed. Cincinnati: United States. Harvey Whitney Books; 2008. p.637-52.
Andrews EB, Gilsenan AW, Cook SF. Therapeutic risk management interventions: feasibility and effectiveness. In: Pharmacoepidemiology and therapeutic risk management. Cincinnati: United States. Harvey Whitney Books; 2008. p.613-33.
Martin RD, Gilsenan AW, Wu Y, Midkiff KD, Masica DN. Long-term post-marketing studies: flexibility, perseverance and patience. Presented at the North American Association of Central Cancer Registries Annual Meeting; 2007.
Gilsenan A, Tennis P, Andrews EA, Zhou X, Coste F, Radigue C. Is it feasible to conduct a cohort study via the internet? Poster presented at the 21st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2005. Nashville, TN.
Gilsenan A, Zhou X, Tennis P, Andrews EA, Coste F, Radigue C. Should we believe results obtained from an internet-based cohort study? Presented at the 21st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2005. Nashville, TN.
Burdett AN, Gard C, Gilsenan A, Hirji Z, Raskin J, Miller D. Prevalence and costs associated with treating depression with painful physical symptoms in a Canadian administrative services database. Poster presented at the 21st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2005. Nashville, TN.
Gilsenan AW, Andrews EB, Burdett AN, Martin R. Post-marketing safety surveillance studies requiring access to patients and charts: does persistence yield results? Poster presented at the 21st ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2005. Nashville, TN.
Lopez R, Gilsenan AW, Zhou X, Myrie L. Attempt – Assessment methodology and study population description. Poster presented at the Sanofi-Aventis Recherche et Développement's Expert Meeting; May 2004.
West R, Curry SJ, Fiore MC, Sullivan SD, Neighbors D, Gilsenan AW, Smadja E, Lavaud V. Attempt cohort: weight gain concern of smokers intending to quit. Poster presented at the 10th Annual Scientific Sessions of the Society for Research on Nicotine and Tobacco; February 2004. Scottsdale, AZ.
Andrews EB, Gilsenan A, Cook SF. Therapeutic Risk Management Interventions: feasibility and Effectiveness. J Am Pharm Assoc. 2004 Jan 1;44(4):491-500.
Gilsenan AW. Depression and pain in the primary care setting. Presented at the Correlation Between Depression and Pain: Creating a New Treatment Paradigm to Evaluate Cost and Caliber of Care. Symposia at the Academy of Managed Care Pharmacy 2002 Educational Conference; October 2002. Washington, DC.
Andrews EB, Mitchell AA, Seligman P, Cook SF, Gilsenan AW. Risk management: what are we driving, where are we going, and how will we know when we get there? Presented at the 18th International Conference on Pharmacoepidemiology; August 2002.
Gilsenan AW. Development of a minimum dataset (MDS)-based comorbidity index for a nursing home population. Poster presented at the Fourth International Society for Pharmacoeconomics and Outcomes Research Congress; 2001. [abstract] Value Health. 2001 Sep; 4(6):417-8.
Sloan FA, Whetten-Goldstien K, Gilsenan AW. Hospital pharmacy decisions: cost-containment, and use of cost-effectiveness analysis. Soc Sci Med. 1997 Aug;45(4):523-33.
Sloan FS, Whetten-Goldstein K, Gilsenan AW. Use of cost-effectiveness analysis in US hospitals. Presented at the Cost-Effectiveness Analysis in Decision-Making Conference; 1995. Durham, NC.