| 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.
|
| Document Type(s): Article, |
| Countries: USA, |
| Click here for the abstract |
C:
Y: |
Guidelines, Regulatory,
2021 |
|
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 |
|
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
|
| Document Type(s): Article, |
| Countries: USA, |
| Click here for the abstract |
C:
Y: |
Guidelines,
2020 |
|
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
|
| 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, |
| Click here for the abstract |
C:
Y: |
Dermatology, Guidelines, Health status & patient reported outcomes, Infectious disease, Infectious disease,
2019 |
|
L:
A: |
English
Burden of illness, Clinical setting: Primary care, direct-to-patient research, Observational study, |
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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
|
| Document Type(s): Poster, |
| Countries: Italy, |
C:
Y: |
Guidelines, Respiratory disease,
2017 |
|
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.
|
| Document Type(s): Poster, |
| Countries: Italy, |
C:
Y: |
Guidelines, Health policy,
2016 |
|
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.
|
| Document Type(s): Poster, |
| Countries: Italy, |
C:
Y: |
Guidelines, Health policy,
2016 |
|
L:
A: |
English
Review, |
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| Discrepancy between guidelines for stroke prevention in atrial fibrillation and practice patterns in primary care. The nationwide French AFIGP survey |
| Author(s): Sabouret P1, Bricard M2, Hermann MA2, Cotté FE2, Deret-Bixio L2, Rushton-Smith S3. |
| Affiliations(s): 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. |
Publication(s): Arch Cardiovasc Dis. 2015 Nov;108(11):544-53. doi: 10.1016/j.acvd.2015.05.005. Epub 2015 Jun 22.
|
| Document Type(s): Article, |
| Countries: France, |
C:
Y: |
Cardiovascular disease, Guidelines, Public Health,
2015 |
|
L:
A: |
English
Retrospective database analysis, |
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