Gianluca Trifiro

BioOHDSI Publications

Gianluca Trifirò, MD, PhD
Assistant Professor of Pharmacology
University of Messina (& Erasmus University Medical Center)

Gianluca Trifiró is an Italian MD with Post-graduation Degree in Clinical Pharmacology, a Master of Science in Clinical Epidemiology and a PhD in pharmacoepidemiology Currently, he works as Honorary Assistant Professor at the Department of Medical Informatics of Erasmus University Medical Center and at the University of Messina. He is also appointed as member of Scientific Secretariat of Italian Drug Agency and Sicilian Regional Drug Formulary. He is consultant of the Italian College of General Practitioners for the conduct of pharmacoepidemiology studies using the GP nationwide database.

In the last years, his main research activities concern the scientific coordination and management of multicentre, international projects (i.e. EU-ADR, ARITMO, SUCRE, SAFEGUARD, MPI-AGE) aimed at assessing the post-marketing drug (including biosimilars) use and safety using multiple European electronic medical record databases.In particular, as regard the European project “EU-ADR” (Exploring and understanding adverse drug reactions by integrative mining of clinical records and biomedical knowledge), he led a work package concerning the system validation and a task force for the outcome data extraction harmonization across multiple heterogeneous databases. Some of the main activities that he specifically led were: a) the creation of a list of high priority adverse events to be investigated when applying data mining on large amount of electronic health records, and b) the comparison of signal detection using either electronic medical records or spontaneous reporting database system. For this task, a list of a surrogate reference standard of drug-adverse event associations based on existing scientific literature and expert opinion was newly developed with the final aim to evaluate the precision of the two systems in terms of signal detection. As follow-up of this task, he collaborated with OHDSI to establish an integrated knowledge base of drugs and health outcomes of interest. Also he collaborated with some OHSDI partners to develop new methodologies for detection of potential drug safety signals related to long-term drug exposure in longitudinal observational data.

Additionally, he is referee for the research grants funded by the European Commission (FP7, ERC and Horizon 2020 program), authors of more than 120 scientific peer-reviewed scientific publications in international journals in the area of pharmacovigilance and pharmacoepidemiology and member of editorial boards of several international journals including Drug Safety and Clinical Drug Investigation.

Pacurariu AC, Straus SM, Trifirò G, Schuemie MJ, Gini R, Herings R, Mazzaglia G, Picelli G, Scotti L, Pedersen L, Arlett P, van der Lei J, Sturkenboom MC, Coloma P. Useful interplay between spontaneous ADR reports and electronic healthcare records as sources of safety signals. Drug Safety. In press

de Bie S, Coloma P, Ferrajolo C, Verhamme K, Trifirò G, Schuemie M, Straus S, Gini R, Herings R, Mazzaglia G, Picelli G, Ghirardi A, Pedersen L, Stricker B, van der Lei J, Sturkenboom M. The Role of Electronic Healthcare Record Databases in Paediatric Drug Safety Surveillance: a Retrospective Cohort Study. Br J Clin Pharmacol. 2015 Aug;80(2):304-14.

Patadia VK, Schuemie MJ, Coloma P, Herings R, van der Lei J, Straus S, Sturkenboom M, Trifirò G, on behalf of the EU-ADR consortium. Evaluating performance of electronic healthcare records and spontaneous reporting data in drug safety signal detection. Int J Clin Pharm. 2015 Feb;37(1):94-104.

Patadia VK, Coloma P, Schuemie MJ, Herings R, Gini R, Mazzaglia G, Picelli G, Fornari C, Pedersen L, van der Lei J, Straus S, Sturkenboom M, Trifirò G, on behalf of the EU-ADR consortium. Using Real-World Healthcare Data for Pharmacovigilance Signal Detection – the Experience of the EU-ADR Project. Expert Rev Clin Pharmacol. 2015 Jan;8(1):95-102.

Boyce RD, Ryan PB, Norén GN, Schuemie MJ, Reich C, Duke J, Tatonetti NP, Trifirò G, Harpaz R, Overhage JM, Hartzema AG, Khayter M, Voss EA, Lambert CG, Huser V, Dumontier M. Bridging Islands of Information to Establish an Integrated Knowledge Base of Drugs and Health Outcomes of Interest. Drug Saf. 2014 Aug;37(8):557-67.

Ferrajolo C, Capuano A, Trifirò G, Moretti U, Rossi F, Santuccio C. Paediatric Drug Safety Surveillance in Italian Pharmacovigilance Network: an Overview of Adverse Drug Reactions in the years 2001-2012. Expert Opin Drug Saf. 2014 Sep;13 Suppl 1:S9-20.

Schuemie M, Trifirò G, Coloma P, Ryan P, Madigan D. Detecting adverse drug reactions following long-term exposure in longitudinal observational data: The Exposure-adjusted Self-Controlled Case Series. Stat Methods Med Res. 2014 Mar 31. [Epub ahead of print].

Valkhoff V, Coloma P, Masclee G, Gini R, Innocenti F, Lapi F, Molokhia M, Mosseveld M, Schou Nielsson M, Schuemie M, Thiessard F,van der Lei J, Sturkenboom M, Trifirò G., on behalf of the EU-ADR Consortium. Validation study in four health-care databases: upper gastrointestinal bleeding misclassification affects precision but not magnitude of drug-related upper gastrointestinal bleeding risk. J Clin Epidemiol. 2014 Aug;67(8):921-31.

Ferrajolo C, Coloma P, Verhamme KMC, Schuemie M, de Bie S, Gini R, Herings R, Mazzaglia G,Picelli G,Giaquinto C, Scotti L, Avillach P, Pedersen L, Rossi F, Capuano A, van der Lei J, Trifiró G, and Sturkenboom M.C.J.M., on behalf of EU-ADR consortium. Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network. Drug Saf. 2014; 37:99-108.

Trifirò G, P. Coloma, P. Rijnbeek, S. Romio, B. Mosseveld, D. Weibel, J. Bonhoeffer, M. Schuemie, J. van der Lei, and M. Sturkenboom. Combining multiple healthcare databases for post-marketing drug and vaccine safety surveillance: why and how? J Intern Med. 2014 Jun;275(6):551-61.

Coloma P, Schuemie M, Trifirò G, Furlong L, van Mulligen E, Bauer-Mehren A, Avillach P, Kors J, Sanz F, Mestres J, Luis Oliveira J, Boyer S, Ahlberg Helgee E, Molokhia M, Matthews J, Prieto-Merino D, Gini R, Herings R, Mazzaglia G, Picelli G, Scotti L, Pedersen L, van der Lei J, Sturkenboom M on behalf of the EU-ADR consortium. Drug-induced Acute Myocardial Infarction: Identifying ‘Prime Suspects’ from Electronic Healthcare Records-based Surveillance System. Plos One 2013; 8:e72148.

Coloma P, Valkhoff V, Mazzaglia G, Nielsson MS, Pedersen L, Molokhia M, Mosseveld M, Morabito P, Schuemie M, Sturkenboom M, Trifirò G, on behalf of the EU-ADR Consortium. Identification of acute myocardial infarction from electronic healthcare records using different disease coding systems: a validation study in three European countries. BMJ Open 2013 Jun 20; 3(6).

Avillach P, Dufour JC, Diallo G, Salvo F, Joubert M, Thiessard F, Mougin F, Trifirò G, Fourrier-Réglat A, Pariente A, Fieschi M. Design and Validation of an Automated Method to Detect Known Adverse Drug Reactions in MEDLINE: a Contribution from the EU-ADR Project. JAMIA. 2013 May; 20: 446-52.

Avillach P, Coloma P, Gini R, Schuemie M, Mougin F, Dufour JC, Mazzaglia G, Giaquinto C, Fornari C, Herings R, Molokhia M, Pedersen L, Fourrier-Réglat A, Fieschi M, Sturkenboom M, van der Lei J, Pariente A, and Trifirò G, on behalf of the EU-ADR consortium. Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project. J Am Med Inform Assoc. 2013 Jan 1;20(1):184-92

Coloma P, Avillach P, Schuemie M, Ferrajolo C, Pariente A, Salvo F, Fourrier-Reglat A, Patadia V, Ottosson A, Molokhia M, van der Lei J, Sturkenboom M, and Trifirò G. A Reference Standard for Evaluation of Methods for Drug Safety Signal Detection using Electronic Healthcare Records (EHR) Databases. Drug Saf. 2013 Jan;36(1):13-23.

Coloma P, Trifirò G, Patadia V and Sturkenboom M. Post-marketing safety surveillance: where does signal detection using electronic healthcare records fit into the big picture? Drug Saf. 2013 Mar; 36:183-97.

Schuemie M, Coloma P, Straatman H, Herings R, Trifirò G, Matthews J, Prieto-Merino D, Molokhia M, Pedersen L, Gini R, Innocenti F, Mazzaglia G, Picelli G, Scotti L, van der Lei J, Sturkenboom M. Using electronic healthcare records for drug safety signal detection: a comparative evaluation of statistical methods. Med Care. 2012 Oct;50(10):890-7.

van Mulligen E, Fourrier-Reglat A, Gurwitz D, Molokhia M, Nieto A, Trifirò G, Kors JA, Furlong LI. EU-ADR Corpus: Annotated Drugs, Diseases, Targets, and their Relationships. J Biomed Inform. 2012 Oct;45(5):879-84.

Coloma PM, Trifirò G, Schuemie MJ, Gini R, Herings R, Hippisley-Cox J, Mazzaglia G, Picelli G, Corrao G, Pedersen L, van der Lei J, and Sturkenboom MCJM on behalf of the EU-ADR consortium. Electronic healthcare databases for active drug safety surveillance: Is there enough leverage? Pharmacoepidemiol Drug Saf. 2012 Jun;21(6):611-621

Coloma P, Schuemie M, Trifirò G, Gini R, Herings R, Hippisley-Cox J, Mazzaglia G, Giaquinto C, Corrao G, Pedersen L, van der Lei J, and Sturkenboom M, on behalf of the EU-ADR consortium. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf 2011; 20(1):1-11

Trifirò G, Pariente A, Coloma PM, Kors JA, Polimeni G, Miremont-Salamé G, Catania MA, Salvo F, David A, Moore N, Caputi AP, Sturkenboom M, Molokhia M, Hippisley-Cox J, Acedo CD, van der Lei J, Fourrier-Reglat A; EU-ADR group. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf. 2009; 18:1176-84.