IQVIA™ Real-World Insights Bibliography

Replication of randomized clinical trial results using real-world data: paving the way for effectiveness decisions
Author(s): Kristin M Sheffield , Nancy A Dreyer , James F Murray, Douglas E Faries & Megan N Klopchin
Affiliations(s): 1Global Patient Outcomes & Real World Evidence, Eli Lilly & Company, Indianapolis, IN 46225, USA 2IQVIA Real-World & Analytic Solutions, Cambridge, MA 02139, USA 3Real World Analytics, Eli Lilly & Company, Indianapolis, IN 46225, USA
Publication(s):  Published Online:11 Sep 2020https://doi.org/10.2217/cer-2020-0161
Document Type(s): Article,
Countries: USA,
Click here for the abstract
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Drug safety, Drug Utlization Study, Guidelines, Methodology, Public Health,
2020
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English
Methodology, Observational study, Population Based Study,
  Add to report
 
 
Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms
Author(s): Mehmet Burcu 1, Nancy A Dreyer 2, Jessica M Franklin 3, Michael D Blum 4, Cathy W Critchlow 5, Eleanor M Perfetto 6, Wei Zhou 1
Affiliations(s): 1Center for Observational and Real-World Evidence, Merck & Co., Inc., West Point, Pennsylvania, United States. 2Real-World Solutions, IQVIA, Cambridge, Massachusetts. 3Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. 4Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, White Oak, Maryland. 5Center for Observational Research, Amgen Inc., Thousand Oaks, California. 6National Health Council, Washington, District of Columbia, and University of Maryland Baltimore (UMB), Baltimore, Maryland.
Publication(s):  Pharmacoepidemiol Drug Saf . 2020 Oct;29(10):1228-1235. doi: 10.1002/pds.4975. Epub 2020 Mar 11.
Document Type(s): Article,
Countries: USA,
Click here for the abstract
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Drug safety,
2020
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English
Epidemiological study, Real World Data, Real World Evidence,
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Ability of primary care health databases to assess medicinal products discussed by the European Union Pharmacovigilance Risk Assessment Committee
Author(s): Robert Flynn1,2,*, Karin Hedenmalm1, Tarita Murray-Thomas3, Alexandra Pacurariu1, Peter Arlett1, Hilary Shepherd3, Puja Myles3, Xavier Kurz1
Affiliations(s): 1 Pharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The Netherlands 2 Medicines Monitoring Unit (MEMO), Division of Molecular and Clinical Medicine, University of Dundee, Dundee, United Kingdom 3 Clinical Practice Research Datalink (CPRD), MHRA, London, United Kingdom
Publication(s):  First published: 18 January 2020 https://doi.org/10.1002/cpt.1775
Document Type(s): Abstract, Article,
Countries: France, Germany, UK,
Click here for the abstract
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Database Validity and methodology, Drug safety, Health policy,
2020
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English
Retrospective database analysis,
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Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe
Author(s): Fife D, Waller J, Kaplan S, Hu P, Phillips S, Oliveria SA, Richarz U
Affiliations(s): Fife: Janssen Research and Development, LLC Waller: Adephi Real World Kaplan: Teva Pharmaceutical Indusries Ltd. Hu: Janssen Global Services Phillips: IQVIA Oliveria, IQVIA Richarz: Janssen Research and Development, LLC
Publication(s):  Clin Drug Investig (2019). https://doi.org/10.1007/s40261-019-00831-3
Document Type(s): Article,
Countries: Belgium, France, Germany, Spain, UK,
Click here for the abstract
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Drug safety, Drug Utlization Study,
2019
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English
Population Based Study, Retrospective database analysis,
  Add to report
 
 
European Multi-Country Drug Utilization Study of Dulaglutide
Author(s): Ayad K. Ali1, Karen E. Wells2, Mathieu Ros?3, Massoud Toussi3
Affiliations(s): 1Eli Lilly and Company, Indianapolis, IN, USA 2IQVIA, Oakland, MI, USA 3IQVIA, Courbevoie, France
Publication(s):  ICPE, Philadelphia, USA, 24-28 August 2019
Document Type(s): Abstract,
Countries: France, Germany, Spain, Sweden, UK,
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Diabetes, Drug safety,
2019
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English
Epidemiological study, Observational study, Retrospective cohort analysis, Retrospective database analysis,
  Add to report
 
 
Methods, Results, and Lessons Learned from Two Postmarketing Drug Safety Surveillance Studies Linking State Cancer Registry Data to Large Pharmacy Databases
Author(s): Harris D1; Casso D2; Midkiff K1; Anderson A2; Gilsenan A1; Oliveria SA2; Andrews E1; KellierSteele N3
Affiliations(s): 1RTI Health Solutions, Research Triangle Park, NC, United States 2IQVIA, Plymouth Meeting, PA, United States 3Eli Lilly and Company, Indianapolis, IN, United States
Publication(s):  NAACCR / IACR Combined Annual Conference, Vancouver, Canada, 9-13 June 2019
Document Type(s): Abstract,
Countries: USA,
Click here for the abstract
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Drug safety,
2019
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English
Epidemiological study, Observational study, Retrospective cohort analysis, Retrospective database analysis,
  Add to report
 
 
Osteosarcoma Surveillance Program Estimating the Incidence of Osteosarcoma Among Teriparatide (Forteo) Users by Linking State Cancer Registry Data to Pharmacy Database Data (United States)
Author(s): Kellier-Steele N1, Anderson A2, Casso D2, Oliveria SA2, Gilsenan A3, Midkiff K3, Harris D3, Andrews E3
Affiliations(s): 1Eli Lilly and Company, Indianapolis, USA, 2IQVIA, Durham, USA, 3RTI-HS, Raleigh, USA
Publication(s):  WCO, Paris France, 4-7 April 2019
Document Type(s): Abstract,
Countries: USA,
Click here for the abstract
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Drug safety,
2019
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A:
English
Epidemiological study, Observational study, Retrospective cohort analysis, Retrospective database analysis,
  Add to report
 
 
Evaluation of the effectiveness of risk minimisation measures: a survey among health care professionals to assess their knowledge and attitudes on prescribing conditions of Instanyl® in France and the Netherlands.
Author(s): Toussi M1, Garofano A1, Jouaville L1, Bardoulat I1, Mitrofan L1
Affiliations(s): 1 QuintilesIMS, La Défense, France
Publication(s):  33rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management, 2017, August 26-30, Montreal, Canada
Document Type(s): Poster,
Countries: France, Netherlands,
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Drug safety, Pain, Risk Management & REMS,
2017
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English
Clinical setting: hospital, Clinical setting: Primary care, clinical setting: Secondary care, Public Health, Survey research,
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Developing a Multi-Phase Claims-Based Algorithm to Facilitate the Study of Drug Exposure During Pregnancy
Author(s): Phillips S, Johnson KJ, Shen SW, Woodcroft KJ, Oliveria SA, Simon TA
Affiliations(s): Phillips S: IQVIA; Johnson KJ: IQVIA (formerly); Shen SW: Bristol-Meyers Squibb; Woodcroft KJ: Henry Ford Health System; Oliveria SA: IQVIA; Simon TA: Bristol Meyers Squibb
Publication(s):  American College of Rheumatology Annual Meeting, 3-8 November 2017
Document Type(s): Abstract,
Countries: USA,
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Database Validity and methodology, Drug safety, Patient Registries & Real-World Study Methods, Pregnancy,
2017
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English
Database Study, Epidemiological study, Retrospective database analysis,
  Add to report
 
 
Unspecified intestinal malabsorption in patients treated with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers: a retrospective analysis in primary care settings
Author(s): De Bortoli N1, Ripellino C2, Cataldo N3, Marchi S1
Affiliations(s): 1 Gastroenterology Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy 2 Department of Real World Evidence, HEOR Consultant Freelance, Milan, Italy 3 Department of Real World Evidence, QuintilesIMS, Milan, Italy
Publication(s):  Expert Opinion on Drug Safety. doi: 10.1080/14740338.2017.1376647. [Epub ahead of print]
Document Type(s): Article,
Countries: Germany, Italy,
Click here for the abstract
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Drug safety, Gastrointestinal disorders, Rare Diseases,
2017
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English
Clinical setting: Primary care, Database Study, Real World Data, Real World Evidence, Retrospective cohort analysis, Retrospective database analysis,
  Add to report
 
 
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