Selection from HEOR Bibliography

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Condition: Guidelines
 
A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe.
Authors: Jouaville LS, Paul T, Almas MF
Affiliations: IQVIA
Publications: 
Pharmacoepidemiol Drug Saf. 2021 Sep;30(9):1143-1152. doi: 10.1002/pds.5301.
Document Types: , Article
Countries: , Europe
Abstract: https://onlinelibrary.wiley.com/doi/full/10.1002/pds.5301
Condition Year Language Analysis type
, Guidelines, Methodology, Risk Management & REMS 2021 English , Literature Review
 
 
Real-world evidence to support regulatory decision making: New or expanded medical product indications
Authors: Franklin JM, Liaw KL, Iyasu S, Critchlow CW, Dreyer NA.
Affiliations: 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.
Publications: 
Pharmacoepidemiol Drug Saf . 2021 Jun;30(6):685-693. doi: 10.1002/pds.5222. Epub 2021 Mar 18.
Document Types: , Article
Countries: , USA
Abstract: https://pubmed.ncbi.nlm.nih.gov/33675248/
Condition Year Language Analysis type
, Guidelines, Regulatory 2021 English , Real World Data, Real World Evidence
 
 
Replication of randomized clinical trial results using real-world data: paving the way for effectiveness decisions
Authors: Kristin M Sheffield , Nancy A Dreyer , James F Murray, Douglas E Faries & Megan N Klopchin
Affiliations: 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
Publications: 
Published Online:11 Sep 2020https://doi.org/10.2217/cer-2020-0161
Document Types: , Article
Countries: , USA
Abstract: https://www.futuremedicine.com/doi/10.2217/cer-2020-0161
Condition Year Language Analysis type
, Drug safety, Drug Utlization Study, Guidelines, Methodology, Public Health 2020 English , Methodology, Observational study, Population Based Study
 
 
Methods for external control groups for single arm trials or long-term uncontrolled extensions to randomized clinical trials
Authors: 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: 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.
Publications: 
PMID: 32964514 PMCID: PMC7756307 DOI: 10.1002/pds.5141 Published online 2020 Oct 4. doi: 10.1002/pds.5141
Document Types: , Article
Countries: , USA
Abstract: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756307/
Condition Year Language Analysis type
, Guidelines 2020 English , Epidemiological study, Real World Data, Real World Evidence
 
 
Dose increase beyond labelled dose of biologics is associated with incremental pharmacy costs: results from a real-world study in the UK
Authors: Anthony Bewley 1, Cristiana Miglio 2, Haijun Tian 3, Isabelle Gilloteau 4, Joannah Whitehead 5, Ruben Hermans 2
Affiliations: 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.
Publications: 
J Dermatolog Treat . 2019 Jun;30(4):376-382. doi: 10.1080/09546634.2018.1524820. Epub 2018 Nov 19.
Document Types: , Article
Countries: , UK
Abstract: https://pubmed.ncbi.nlm.nih.gov/30256686/
Condition Year Language Analysis type
, Dermatology, Guidelines, Health status & patient reported outcomes, Infectious disease, Infectious disease 2019 English , Burden of illness, Clinical setting: Primary care, direct-to-patient research, Observational study
 
 
Dose increase beyond labelled dose of biologics is associated with incremental pharmacy costs: results from a real-world study in the UK
Authors: Anthony Bewley 1, Cristiana Miglio 2, Haijun Tian 3, Isabelle Gilloteau 4, Joannah Whitehead 5, Ruben Hermans 2
Affiliations: 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.
Publications: 
PMID: 30256686 DOI: 10.1080/09546634.2018.1524820
Document Types: , Article
Countries: , UK
Abstract: https://pubmed.ncbi.nlm.nih.gov/30256686/
Condition Year Language Analysis type
, Drug safety, Drug Utlization Study, Guidelines, Health status & patient reported outcomes 2019 English , direct-to-patient research, Methodology, Survey research
 
 
Guidelines in Germany Early Benefit Assessment - Which Guidelines are Considered by Federal Joint Committee for Determining the Appropriate Comparator?
Authors: Scheler E, Stratil AS, Roxlau T, Bonduelle D
Affiliations: IQVIA Commercial GmbH & Co. OHG, Munich, Germany
Publications: 
Document Types: , Abstract, Poster
Countries: , Germany
Condition Year Language Analysis type
, Guidelines, Health policy 2018 German , Review
 
 
Cost and treatment of asthma and COPD in the real practice: a regional segmentation
Authors: Sernissi F1, Rova A1, Mantuano M1, Urbinati D1
Affiliations: QuintilesIMS, Milan, Italy
Publications: 
ISPOR 20th Annual European Congress, 4-8 November 2017, Glasgow, Scotland
Document Types: , Poster
Countries: , Italy
Condition Year Language Analysis type
, Guidelines, Respiratory disease 2017 English , Database Study, Literature Review
 
 
Comparison of biosimilar guideline and real consumption among Italian regions.
Authors: Tettamanti A1, Tucci C1, Urbinati D1.
Affiliations: 1 IMS Health, Milan, Italy.
Publications: 
ISPOR 19th Annual European Congress, 2016, 29 October-2 November, Vienna, Austria.
Document Types: , Poster
Countries: , Italy
Condition Year Language Analysis type
, Guidelines, Health policy 2016 English , Review
 
 
The impact of regional legislative measures on the prescription of off-patent medicines.
Authors: Tettamanti A1, Tucci C1, Urbinati D1.
Affiliations: IMS Health, Milan, Italy
Publications: 
ISPOR 19th Annual European Congress, 2016, 29 October-2 November, Vienna, Austria.
Document Types: , Poster
Countries: , Italy
Condition Year Language Analysis type
, Guidelines, Health policy 2016 English , Review
 
 
Discrepancy between guidelines for stroke prevention in atrial fibrillation and practice patterns in primary care. The nationwide French AFIGP survey
Authors: Sabouret P1, Bricard M2, Hermann MA2, Cotté FE2, Deret-Bixio L2, Rushton-Smith S3.
Affiliations: Heart Institute, Department of Cardiology, Pitié-Salpétrière Hospital, Pierre-and-Marie-Curie University, 75013 Paris, France. Electronic address: pierre.sabouret@psl.aphp.fr. 2Bristol-Myers Squibb, 92500 Rueil-Malmaison, France. 3Thrombosis Research Institute, SW3 6LR London, UK.
Publications: 
Arch Cardiovasc Dis. 2015 Nov;108(11):544-53. doi: 10.1016/j.acvd.2015.05.005. Epub 2015 Jun 22.
Document Types: , Article
Countries: , France
Condition Year Language Analysis type
, Cardiovascular disease, Guidelines, Public Health 2015 English , Retrospective database analysis
 
 
Use of ADH antagonists results in lower hospital resource usage: a retrospective cohort study
Authors: Paul Grant 1 , Clare Jamookeeah 2 , Penny Dhanjal 2 & Gethin Griffith 2
Affiliations: 1Royal Sussex County Hospital, Brighton, UK; 2Otsuka Pharmaceuticals (UK) Ltd, Wexham, UK.
Publications: 
Endocrine Abstracts (2015) 38 P20 | DOI: 10.1530/endoabs.38.P20
Document Types: , Abstract
Countries: , UK
Abstract: https://www.endocrine-abstracts.org/ea/0038/ea0038p20
Condition Year Language Analysis type
, Guidelines, Hematology, Methodology 2015 English , Burden of illness, direct to patient research, Retrospective cohort analysis, Review
 
 
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