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QuintilesIMS Real-World Insights Bibliography
| Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy |
| Author(s): Nancy A Dreyer1, MPH, PhD ;Stella CF Blackburn2, MBBS, MA, MSc ; Shahrul Mt-Isa3, BSc, PhD ; Jonathan L Richardson4,5, BBSc (Hons) ; Simon Thomas4,5, BSc, MD, FRCP ;
Maja Laursen6, MSc, PhD ;
• Priscilla Zetstra-van der Woude7, MSc ;
Anna Jamry-Dziurla8, MSc ;
Valerie Hliva9, PhD ;
Alison Bourke10, BSc, MSc ;
Lolkje de Jong-van den Berg7, PharmD, PhD
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| Affiliations(s): 1Quintiles Real-World & Late Phase Research, Cambridge, MA, United States |
| Publication(s): |
| Document Type(s): Article |
| Countries: Denmark, Netherlands, Poland, UK |
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Drug safety, Pregnancy
2015 |
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English
direct-to-patient research, Internet or Interactive voice response system, Prospective study |
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| Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy. |
| Author(s): Dreyer NA1, Blackburn SC2, Mt-Isa S3, Richardson JL4, Thomas S4, Laursen M5, Zetstra-van der Woude P6, Jamry-Dziurla A7, Hliva V8, Bourke A9, de Jong-van den Berg L6. |
| Affiliations(s): 1Quintiles Real-World & Late Phase Research Cambridge, MA United States.
2Quintiles Real-World & Late Phase Research Reading United Kingdom.
3Imperial College London United Kingdom.
4Institute of Cellular MedicineNewcastle UniversityNewcastle upon TyneUnited Kingdom; UK Teratology Information ServiceNewcastle HospitalsNHS Foundation TrustNewcastle upon TyneUnited Kingdom.
5Statens Serum Institut Copenhagen Denmark.
6University of Groningen Groningen Netherlands.
7Poznan University of Medical Sciences Poznan Poland.
8Quintiles Real-World & Late-Phase Research St. Prex Switzerland.
9IMS London United Kingdom. |
| Publication(s): JMIR Public Health Surveill. 2015 Dec 22;1(2):e22. |
| Document Type(s): Article |
| Countries: Denmark, Netherlands, Poland, UK |
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Drug safety, Womens Health
2015 |
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English
direct-to-patient research |
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| Direct-To-Patient Research: The Future of Pharmacovigilance |
| Author(s): Dreyer NA, Mt. Isa S, Richardson JL, Laursen M, Zetstravan der Woude PA, Jamry-Dziurla A, Hliva V, Bourke A |
| Affiliations(s): |
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| Document Type(s): Poster |
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Drug safety
2015 |
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English
RWLPR (Real-World Late Phase Research-quintiles |
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| Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection |
| Author(s): Pacurariu AC1,2, Straus SM1,2, Trifirò G1,3, Schuemie MJ1, Gini R4, Herings R5, Mazzaglia G6, Picelli G7, Scotti L8, Pedersen L9, Arlett P10, van der Lei J1, Sturkenboom MC1, Coloma PM11. |
| Affiliations(s): 1Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.2Dutch Medicines Evaluation Board, Utrecht, The Netherlands.
3Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.4Agenzia Regionale di Sanità della Toscana, Florence, Italy.5PHARMO Institute, Utrecht, The Netherlands.6Società Italiana di Medicina Generale, Florence, Italy.7Pedianet-Società Servizi Telematici SRL, Padua, Italy.8Department of Statistics, Università di Milano-Bicocca, Milan, Italy.9Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.10European Medicines Agency, London, UK.11Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands |
| Publication(s): Drug Saf. 2015 Sep 14 |
| Document Type(s): Abstract |
| Countries: Italy |
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Drug safety
2014 |
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English
Retrospective database analysis |
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| Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network. |
| Author(s): Ferrajolo C, Coloma PM, Verhamme KM, Schuemie MJ, 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, Trifiro G, Sturkenboom MC, EU-ADR consortium. |
| Affiliations(s): C. Ferrajolo (&) P. M. Coloma K. M. C. Verhamme
M. J. Schuemie S. de Bie J. van der Lei G. Trifiro´
M. C. J. M. Sturkenboom :Department of Medical Informatics, Erasmus University
Medical Center, Dr. Molewaterplein 50, 3015 GE Rotterdam,
The Netherlands
C. Ferrajolo F. Rossi A. Capuano :Pharmacology Section, Department of Experimental Medicine,Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Second University of Naples, Via L. De Crecchio, 7, 80138 Naples, Italy
R. Gini :Regional Health Agency of Tuscany, Florence, Italy
R. Herings: PHARMO Institute, Utrecht, The Netherlands
G. Mazzaglia :Italian College of General Practitioners, Florence, Italy
G. Picelli :Pedianet-Societa` Servizi Telematici SRL, Padua, Italy
C. Giaquinto: Department of Paediatrics, University Hospital of Padua, Padua,
Italy
L. Scotti :Department of Statistics and Quantitative Methods, University of
Milano-Bicocca, Milan, Italy
P. Avillach: LESIM, ISPED, University of Bordeaux 2, Bordeaux, France
L. Pedersen: Department of Clinical Epidemiology, Aarhus University
Hospital, Aarhus, Denmark
G. Trifiro´: Department of Clinical and Experimental Medicine, University
of Messina, Messina, Italy
M. C. J. M. Sturkenboom: Epidemiology, Erasmus University Medical Center, Rotterdam,The Netherlands |
| Publication(s): Drug Saf. 2014 Feb;37(2):99-108 |
| Document Type(s): Article |
| Countries: Italy |
| Click here for the abstract |
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Drug safety, Miscellaneous
2014 |
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English
Retrospective database analysis |
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| Validation study in four health-care databases: upper gastrointestinal bleeding misclassification affects precision but not magnitude of drug-related upper gastrointestinal bleeding risk. |
| Author(s): Valkhoff VE1, Coloma PM2, Masclee GM1, Gini R3, Innocenti F4, Lapi F5, Molokhia M6, Mosseveld M2, Nielsson MS7, Schuemie M2, Thiessard F8, van der Lei J2, Sturkenboom MC9, Trifirò G10; EU-ADR Consortium. |
| Affiliations(s): 1Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam The Netherlands.2Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.3Agenzi Regionali di Sanità della Toscana, Via Pietro Dazzi 1 - 50141, Firenze, Italy.4Health Search, Italian College of General Practitioners, Via del Pignoncino, 9-11,50142, Florence, Italy.5Centre for Clinical Epidemiology, Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montréal, QC H3T 1E2, Canada; Department of Preclinical and Clinical Pharmacology, University of Florence, Piazza di San Marco, 4, 50121 Firenze, Italy.6Department of Primary Care and Public Health Sciences, Kings College London, Division of Health and Social Care Research, 7th Floor, Capital House, 42 Weston Street, London SE1 3QD, United Kingdom.7Department of Clinical Epidemiology, Aarhus University Hospital, Olof Palmes Allé 43-45 DK-8200 Aarhus N, Denmark.8LESIM, ISPED, Universite Bordeaux 2', 146 Rue Léo Saignat, 33076 Bordeaux, France.9Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands; Department of Epidemiology, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.10Department of Medical Informatics, Erasmus University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands; Department of Clinical and Experimental Medicine and Pharmacology, Via Consolare Pompea, 1, Messina, University of Messina, Italy. |
| Publication(s): J Clin Epidemiol. 2014 Aug;67(8):921-31. doi: 10.1016/j.jclinepi.2014.02.020. Epub 2014 May 1. |
| Document Type(s): Article |
| Countries: Europe |
| Click here for the abstract |
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Drug safety, Gastrointestinal disorders
2014 |
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English
Retrospective database analysis |
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| The risk of metabolic disorders in patients treated with asenapine or olanzapine: a study conducted on real-world data in Italy and Spain. |
| Author(s): Maina G, Ripellino C, Pegoraro V, Caresano C. |
| Affiliations(s): |
Publication(s): ISPOR Annual European Congress. 2014, Amsterdam
Value in health |
| Document Type(s): Poster |
| Countries: Italy, Spain |
| Click here for the abstract |
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Drug safety, Neurological disorders
2014 |
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English
Real World Data |
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| Emergency hospitalizations for unsupervised prescription medication ingestions by young children |
| Author(s): Lovegrove MC, Mathew J, Hampp C, Governale L, Wysowski DK, Budnitz DS |
| Affiliations(s): Food and Drug Administration
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| Publication(s): Pediatrics 2014;134(4):e1009-1016. |
| Document Type(s): Article |
| Countries: |
| Click here for the abstract |
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Drug safety
2014 |
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English
Real World Evidence |
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| Prescription Opioid and Heroin Abuse, April 29, 2014 |
| Author(s): Volkow ND, |
| Affiliations(s): House Committee on Energy and Commerce Subcommittee on Oversight and Investigations
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| Publication(s): Testimony to congress.House Committee on Energy and Commerce Subcommittee on Oversight and Investigations |
| Document Type(s): Abstract |
| Countries: |
| Click here for the abstract |
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Drug safety
2014 |
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English
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| Replication of the OMOP experiment in Europe: evaluating methods for risk identification in electronic health record databases. |
| Author(s): Schuemie MJ, Gini R, Coloma PM, Straatman H, Herings RM, Pedersen L, Innocenti F, Mazzaglia G, Picelli G, Van Der Lai J, Sturkenboom MC. |
| Affiliations(s): |
| Publication(s): Drug Saf. 2013 Oct;36 Suppl 1:S159-69. doi: 10.1007/s40264-013-0109-8. |
| Document Type(s): Article |
| Countries: Europe, Italy |
| Click here for the abstract |
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Drug safety, Methodology
2013 |
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English
Methodology, Retrospective database analysis |
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