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.
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Document Type(s): Article, |
Countries: Europe, |
Click here for the abstract |
C: Y: |
Guidelines, Methodology, Risk Management & REMS, 2021 |
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L: A: |
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.
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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.
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Document Type(s): Article, |
Countries: USA, |
Click here for the abstract |
C: Y: |
Guidelines, Regulatory, 2021 |
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L: 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
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Document Type(s): Article, |
Countries: USA, |
Click here for the abstract |
C: Y: |
Drug safety, Drug Utlization Study, Guidelines, Methodology, Public Health, 2020 |
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L: 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
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Document Type(s): Article, |
Countries: USA, |
Click here for the abstract |
C: Y: |
Guidelines, 2020 |
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L: 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
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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.
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Document Type(s): Article, |
Countries: UK, |
Click here for the abstract |
C: Y: |
Dermatology, Guidelines, Health status & patient reported outcomes, Infectious disease, Infectious disease, 2019 |
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L: 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
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Document Type(s): Article, |
Countries: UK, |
Click here for the abstract |
C: Y: |
Drug safety, Drug Utlization Study, Guidelines, Health status & patient reported outcomes, 2019 |
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L: A: |
English direct-to-patient research, Methodology, Survey research, |
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Guidelines in Germany Early Benefit Assessment - Which Guidelines are Considerend by Federal Joint Committee for Determing 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, |
Countries: Germany, |
C: Y: |
Guidelines, Health policy, 2018 |
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L: A: |
German Review, |
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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
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Document Type(s): Poster, |
Countries: Italy, |
C: Y: |
Guidelines, Respiratory disease, 2017 |
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L: A: |
English Database Study, Literature Review, |
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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.
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Document Type(s): Poster, |
Countries: Italy, |
C: Y: |
Guidelines, Health policy, 2016 |
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L: A: |
English Review, |
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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.
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Document Type(s): Poster, |
Countries: Italy, |
C: Y: |
Guidelines, Health policy, 2016 |
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L: A: |
English Review, |
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