IQVIA™ Real-World Insights Bibliography

A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe.
Author(s): Jouaville LS, Paul T, Almas MF
Affiliations(s): IQVIA
Publication(s):  Pharmacoepidemiol Drug Saf. 2021 Sep;30(9):1143-1152. doi: 10.1002/pds.5301.
Document Type(s): Article,
Countries: Europe,
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Guidelines, Methodology, Risk Management & REMS,
2021
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English
Literature Review,
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Real-world evidence to support regulatory decision making: New or expanded medical product indications
Author(s): Franklin JM, Liaw KL, Iyasu S, Critchlow CW, Dreyer NA.
Affiliations(s): 1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. 2Center for Observational and Real-world Evidence, Merck & Co., Inc, Kenilworth, New Jersey, USA. 3Research & Development Strategy and Operations, Amgen, Thousand Oaks, California, USA. 4Real World Solutions, IQVIA, Cambridge, Massachusetts, USA.
Publication(s):  Pharmacoepidemiol Drug Saf . 2021 Jun;30(6):685-693. doi: 10.1002/pds.5222. Epub 2021 Mar 18.
Document Type(s): Article,
Countries: USA,
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Guidelines, Regulatory,
2021
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A:
English
Real World Data, Real World Evidence,
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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,
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Y:
Drug safety, Drug Utlization Study, Guidelines, Methodology, Public Health,
2020
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A:
English
Methodology, Observational study, Population Based Study,
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Methods for external control groups for single arm trials or long-term uncontrolled extensions to randomized clinical trials
Author(s): John D Seeger 1, Kourtney J Davis 2, Michelle R Iannacone 3, Wei Zhou 4, Nancy Dreyer 5, Almut G Winterstein 6, Nancy Santanello 7, Barry Gertz 8, Jesse A Berlin 2
Affiliations(s): 1Life Sciences Epidemiology, Optum, Boston, Massachusetts, USA. 2Global Epidemiology, Johnson & Johnson, Titusville, New Jersey, USA. 3Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. 4Pharmacoepidemiology, Merck & Co., Inc., Kenilworth, New Jersey, USA. 5Real-World Solutions, IQVIA, Cambridge, Massachusetts, USA. 6University of Florida, Gainesville, Florida, USA. 7Nancy Santanello Research Consultant, Philadelphia, Pennsylvania, USA. 8Blackstone, Cambridge, Massachusetts, USA.
Publication(s):  PMID: 32964514 PMCID: PMC7756307 DOI: 10.1002/pds.5141 Published online 2020 Oct 4. doi: 10.1002/pds.5141
Document Type(s): Article,
Countries: USA,
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Guidelines,
2020
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A:
English
Epidemiological study, Real World Data, Real World Evidence,
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Dose increase beyond labelled dose of biologics is associated with incremental pharmacy costs: results from a real-world study in the UK
Author(s): Anthony Bewley 1, Cristiana Miglio 2, Haijun Tian 3, Isabelle Gilloteau 4, Joannah Whitehead 5, Ruben Hermans 2
Affiliations(s): 1a Whipps Cross University Hospital , London , UK. 2b IQVIA , London , UK. 3c Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA. 4d Novartis Pharma AG , Novartis Campus , Basel , Switzerland. 5e Novartis UK Pharmaceuticals Ltd , Frimley, Camberley , UK.
Publication(s):  J Dermatolog Treat . 2019 Jun;30(4):376-382. doi: 10.1080/09546634.2018.1524820. Epub 2018 Nov 19.
Document Type(s): Article,
Countries: UK,
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Dermatology, Guidelines, Health status & patient reported outcomes, Infectious disease, Infectious disease,
2019
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A:
English
Burden of illness, Clinical setting: Primary care, direct-to-patient research, Observational study,
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Dose increase beyond labelled dose of biologics is associated with incremental pharmacy costs: results from a real-world study in the UK
Author(s): Anthony Bewley 1, Cristiana Miglio 2, Haijun Tian 3, Isabelle Gilloteau 4, Joannah Whitehead 5, Ruben Hermans 2
Affiliations(s): 1a Whipps Cross University Hospital , London , UK. 2b IQVIA , London , UK. 3c Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA. 4d Novartis Pharma AG , Novartis Campus , Basel , Switzerland. 5e Novartis UK Pharmaceuticals Ltd , Frimley, Camberley , UK.
Publication(s):  PMID: 30256686 DOI: 10.1080/09546634.2018.1524820
Document Type(s): Article,
Countries: UK,
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Y:
Drug safety, Drug Utlization Study, Guidelines, Health status & patient reported outcomes,
2019
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A:
English
direct-to-patient research, Methodology, Survey research,
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Guidelines in Germany Early Benefit Assessment - Which Guidelines are Considered by Federal Joint Committee for Determining the Appropriate Comparator?
Author(s): Scheler E, Stratil AS, Roxlau T, Bonduelle D
Affiliations(s): IQVIA Commercial GmbH & Co. OHG, Munich, Germany
Publication(s): 
Document Type(s): Abstract, Poster,
Countries: Germany,
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Y:
Guidelines, Health policy,
2018
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A:
German
Review,
  Add to report
 
 
Cost and treatment of asthma and COPD in the real practice: a regional segmentation
Author(s): Sernissi F1, Rova A1, Mantuano M1, Urbinati D1
Affiliations(s): QuintilesIMS, Milan, Italy
Publication(s):  ISPOR 20th Annual European Congress, 4-8 November 2017, Glasgow, Scotland
Document Type(s): Poster,
Countries: Italy,
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Guidelines, Respiratory disease,
2017
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A:
English
Database Study, Literature Review,
  Add to report
 
 
Comparison of biosimilar guideline and real consumption among Italian regions.
Author(s): Tettamanti A1, Tucci C1, Urbinati D1.
Affiliations(s): 1 IMS Health, Milan, Italy.
Publication(s):  ISPOR 19th Annual European Congress, 2016, 29 October-2 November, Vienna, Austria.
Document Type(s): Poster,
Countries: Italy,
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Guidelines, Health policy,
2016
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A:
English
Review,
  Add to report
 
 
The impact of regional legislative measures on the prescription of off-patent medicines.
Author(s): Tettamanti A1, Tucci C1, Urbinati D1.
Affiliations(s): IMS Health, Milan, Italy
Publication(s):  ISPOR 19th Annual European Congress, 2016, 29 October-2 November, Vienna, Austria.
Document Type(s): Poster,
Countries: Italy,
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Guidelines, Health policy,
2016
  L:
A:
English
Review,
  Add to report
 
 
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