Publications
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Gilsenan A, Shakir S, Jokinen J. Pharmacovigilance: beyond signal detection and spontaneous reporting. Presentation to be given at the DIA 2025 Global Annual Meeting; June 16, 2025. Washington, DC.
Nardoni V, Lippi M, Marinai S, Hyeraci G, Maccari M, Arana A, Lucenteforte E, Limoncella G, Mohammadi S, Roberto G, Dehghan Tarazjani A, Virgili G, Weibel D, Gini R. Comparing humans and large language models in filling clinical questionnaires. Presentation to be given at the 4th International Conference Series on Hybrid Human-Artificial Intelligence; June 9, 2025. Pisa, Italy.
Korver D. A gentle introduction to creating graphs in Python, R and SAS. Presentation to be given at the PharmaSUG US Conference; June 2, 2025. San Diego, CA.
Bozzi LM, Johnson R, Heidenreich S, Poulos C. Alternative recruitment options for patient preference studies: thinking outside the market research panel box. Presented at the ISPOR 2025; May 16, 2025. Montréal, Canada.
Copley-Merriman K, Doward L, Hawe E, Cope S. Clinical trial design, beyond the regulatory. Presented at the ISPOR 2025; May 15, 2025. Montréal, Canada.
Brogan A, Zhang K. From data to dialogue: mastering conversations to amplify HEOR impact and influence. Presented at the ISPOR 2025; May 15, 2025. Montreal, Canada.
Riemer J, Campbell K, Arthurs E, Knight C. Cost-effectiveness of belimumab for the treatment of adults with active lupus nephritis in Canada. Presented at the ISPOR 2025; May 15, 2025. Montréal, Canada.
Herring WL, Coon C, Lenderking W, Whittington M. Rethinking clinical meaningfulness and value assessment in the context of chronic progressive diseases. Presented at the ISPOR 2025; May 15, 2025. Montréal, Canada.
Gnanasakthy A, Crawford R, Qin S, Doward L, Rockwood NJ. Advanced patient-reported outcomes. Mastering Patient-Reported Outcomes (PRO) in Drug Development. Presented at the ISPOR 2025; May 13, 2025. Montréal, Canada. Previously presented at the ISPOR Europe 2024.
Garcia de Albeniz Martinez X. Validate study variables to reduce misclassification bias: recent tools and research needs. Presented at the ARS Toscana Webinar; March 27, 2025. Florence, Italy.
Paret K, Chaiyakunapruk N, Ronquest N, Pearson I. Introduction to best practices for country adaptations of economic models - virtual. Presented at the 2025 Virtual ISPOR Short Course Program; March 26, 2025. Previously presented at the 2024 Virtual ISPOR Short Course Program.
Vila Guilera J, Abellan A, Garcia de Albeniz X, Houghton K. External control arm studies in marketing authorisation applications submitted to the European Medicines Agency: a review of study design features and methods. Presented at the Drug Information Association (DIA) Europe 2025; March 18, 2025. Basel, Switzerland.
Ollendorf D, Tsiao E, Whittington M, Ronquest N. Role of economic evaluations in value assessments for pharmaceutical interventions in the United States. Presented at the ISPOR Education Center Online Learning; 2025.
DiBenedetti D. Design considerations for in-trial interviews. Presented at the US Food and Drug Administration Patient-Focused Drug Development Virtual Workshop - Methodological and Other Challenges Related to Patient Experience Data; December 13, 2024.
Earnshaw S, Brogan AJ, Brodtkorb TH, Davis AE. Budget impact analysis II: applications and design issues - virtual. Presented at the 2024 Virtual ISPOR Short Course Program; December 4, 2024. Previously presented at the 2015 ISPOR 20th Annual International Meeting.
Ling C, Hawe E, Stevenson A, Low EW. Giving voice to rare diseases during joint clinical assessment (JCA). Presented at the ISPOR Europe 2024; November 20, 2024. Barcelona, Spain.
van Til J, Poulos C, Thomas C. Using health preference methods for value clarification in patient decision support: current use and future developments. Presented at the ISPOR Europe 2024; November 19, 2024. Barcelona, Spain.
Gnanasakthy A, Crawford R, Qin S, Doward L, Rockwood NJ. Advanced patient-reported outcomes. Presented at the ISPOR Europe 2024; November 17, 2024. Barcelona, Spain. Previously presented at the ISPOR 2024.
Ni L, Harris M, Cotterill G, Hoog M, Basarir H, Deger K, van Hest N, Johansson E. Comparison of cost-effectiveness model outcomes using two individual-level simulation models in obesity. Presented at the ISPOR Europe 2024; November 2024. Barcelona, Spain.
Handels R, Wimo A, Herring WL, Winblad B, Jonsson L. Are anti-amyloid treatments for Alzheimer's disease ready for practice? Long-term effectiveness and cost-effectiveness in Europe. Presented at the 34th Alzheimer Europe Conference; October 9, 2024. Geneva, Switzerland.
Paret K, Chaiyakunapruk N, Ronquest N, Pearson I. Introduction to best practices for country adaptations of economic models - virtual. Presented at the 2024 Virtual ISPOR Short Course Program; October 2, 2024.
Korver D. A gentle introduction to creating SAS and R graphs. Presented at the 2024 Southeast SAS Users Group Conference; September 24, 2024. Bethesda, MD.
Haug U, Morales DR, Ehrenstein V, Esen BO, Didelez V, Schafer W, Reinbold J, Martinez D, Garcia de Albeniz X, Gini R, Ryan O, Young J. Target trial emulation with real world evidence: regulatory grade pharmacoepidemiology in the SIGMA consortium. Presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Arana A, Ehrenstein V, Guo Y, Ryan P. Should confounding control be based on subject-matter knowledge, or driven by the data? A debate. Presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Girardi A, Limoncella G, Hyeraci G, Roberto G, Bartolini C, Paoletti O, Messina D, Villalobos F, Bissacco C, Van den Burg J, Houben E, Santaca k, Lentile V, Ingrasciotta Y, Trifiro G, Hoxhaj V, Duran C, Riera-Arnau J, Garcia P, Martin-Perez M, Huerta-Alvarez C, Llorente-Garcia A, Sanchez-Saez F, Rodriguez-Bernal C, Lassalle R, Jove J, Bernard M, Thurin N, Jordan S, Thayer D, Evans H, Coldea A, Manfrini M, Van Gelder M, Hayati S, Schink T, Tari M, Pajouheshnia R, Afonso A, Noan-Laine M, Molgaard-Nielsen D, Cunnington M, Dodd C, Sturkenboom M, Nordeng H, Gini R. Impact of data source diversity on the distribution of key variables in pregnancy cohorts based on the ConcePTION pregnancy algorithm leveraging a random forest imputation model. Presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Layton JB, Muthuri S, Lindaas A, Lloyd PC, Richey MM, Gruber JF, Clarke TC, Kowarski LS, McKillop M, Fisher S, Lyu H, Cheng A, Bui CL, Duenas PF, Chen Y, Forshee RA, Anderson SA, Beers JB, Burrell T, Chillarige Y, Anthony MS, Shoaibi A. Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States. Presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Peetluk LS, Djibo DA, Layton JB, Deng J, Deshazo J, Richey MM, Ogilvie RP, Parambi RJ, Miller M, Song J, Tarazi W, Weatherby LB, Bell EJ, Anthony MS, McMahill-Walraven CN, Yang GW, Seeger JD, Amend KL. Considerations for negative control outcome analyses in vaccine effectiveness studies: post-hoc analyses from an adult vaccine effectiveness study conducted within the FDA BEST initiative. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Broe A, Willis SK, Dareng E, Haviland M, van Gelder MMHJ, Nordeng HME, Wood ME, Sahin L, Margulis AV, Rivero-Ferrer E. Building global consensus on definitions for drug safety studies in pregnancy to improve harmonized evaluation of real-world data. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Layton JB, Richey M, Lindaas A, Muthuri S, Lloyd PC, Gruber JF, Bui C, McKillop M, Kowarski L, Lyu H, Cheng A, Wan Z, Clarke TC, Kawai AT, Beers J, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS, Shoaibi A. Events on day zero of follow-up: considerations for cohort studies of adverse events after COVID-19 diagnosis. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Garcia de Albeniz Martinez X, Aguado J, Caniglia E, Hernanez-Diaz S, Maringe C, Sterne J. Specification of time zero in causal inference studies using real-world data: challenges and solutions. Presented at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
Khan S, Alkire J, Krumbach A, Talbird S. Best practices for adopting AMCP format version 5.0. Presented at RTI Webinar; August 6, 2024.
Jonsson L, Winblad B, Wimo A, Herring WL. Real-world effectiveness of anti-amyloid therapies: the feasibility of obtaining historic controls from large-scale disease registries. Presented at the Alzheimer's Association International Conference (AAIC) 2024; August 1, 2024. Philadelphia, PA.
Janssen E, Vass C, Levitan B, Hauber B, Bent R, King-Kallimanis B. Effective patient engagement in patient experience data: practical insights from case studies in hard-to-reach populations. Presented at the Drug Information Association (DIA) 2024 Global Annual Meeting; June 18, 2024. San Diego, CA.
Ridley M, Strauss RP, Drake AF, Miller MQ. Narrative study of resilience in facial paralysis: Similarities and differences in the resilience profiles and psychosocial responses of patients with congenital and acquired types. Presented at the Appearance Matters 10 Conference (UWE Bristol); June 11, 2024. Bristol, UK.
Cook C, Carrico J, Talbird S, Gountas I, Skroumpelos A, Boutselakou E, Trimis G, Sabale U, Bencina G. Public health and economic impact of pediatric immunization program in Greece. Presented at the 42nd Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) 2024; May 24, 2024. Copenhagen, Denmark.
Herring WL, Cole A, Phelps CE, Jiao B. Value assessment and reimbursement of early treatment for prevention in chronic progressive diseases: are traditional approaches up to the task? Presented at the ISPOR 2024; May 7, 2024. Atlanta, GA.
Wolowacz S, Lloyd A, Doward L, Hawe E. Estimating health-state utility for economic models in clinical trials and real-world studies. Presented at the ISPOR 2024; May 5, 2024. Atlanta, GA.
Gnanasakthy A, Crawford R, Qin S, Rockwood N, Doward L. Advanced patient-reported outcomes. Presented at the ISPOR 2024; May 5, 2024.
Rao S, Forns J, Danysh HE, Calingaert B, Dempsey C, Aquilina T, Pathak S, Anthony MS, Layton JB. Natural history and clinical outcomes in patients with Alzheimer's disease-related psychosis in the United States. Presented at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) 2024; March 5, 2024. Lisbon, Portugal.
Garcia de Albeniz Martinez X. Analysis methods - casual inference. Presented at the National Academies Board on Health Sciences Policy; February 7, 2024.
Ghaswalla P, Carrico J, Hicks KA. The annual economic burden of respiratory syncytial virus in adults in the United States. Presented at the 2024 Biomedical Advanced Research and Development Authority George Risi Memorial Journal Club; January 22, 2024.
Earnshaw S, Paret K. The role of operations research in access to pharmaceuticals. Presented at the NC State Operations Research Seminar Series; January 22, 2024. Raleigh, NC.
Wang S, Garcia de Albeniz Martinez X. Applications of causal inference frameworks. Presented at the Leveraging RWE to Determine Casual Inference Meeting; December 12, 2023. Durham, NC.
Malec L, Carcao M, Mathias M, Kragh N, Dumont J, Willemze A, Bystricka L, Wilson A, DiBenedetti D. Experiences with efanesoctocog alfa: exit interviews with caregivers of previously treated patients with hemophilia a from the XTEND-Kids phase 3 clinical trial. Presented at the 65th ASH Annual Meeting & Exposition 2023; December 10, 2023. San Diego, CA.