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IQVIA™ Real-World Insights Bibliography
| Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions |
| Author(s): Oriol Sola- Morales (1), Lesley H. Curtis (2), Julien Heidt (3),*, Laura Walsh (4), Deborah Casso (5),?, Susan Oliveria (6),?, Patrick Saunders- Hastings (7), Yufei Song (8),?, Tiffany Mercado (3), Robbert Zusterzeel (3),?, Vera Mastey (9), James Harnett (9) and Ruben G. W. Quek (9) |
| Affiliations(s): (1) Fundació Health Innovation Technology Transfer and International, University of Catalonia, Barcelona, Spain; (2) Duke Clinical Research Institute, Durham, North Carolina, USA; (3) IQVIA, Regulatory Science and Strategy, Falls Church, Virginia, USA; (4) IQVIA, Epidemiology and Drug Safety Practice, Boston, Massachusetts, USA; (5) IQVIA, Epidemiology and Drug Safety Practice, Seattle, Washington, USA; (6) IQVIA, Epidemiology and Drug Safety Practice, New York, New York, USA; (7) Epi Excellence LLC, Garnet Valley, Pennsylvania, USA; (8) IQVIA, Epidemiology and Drug Safety Practice, Beijing, China; (9) Regeneron Pharmaceuticals Inc., Health Economics & Outcomes Research, Tarrytown, New York, USA |
Publication(s): Clinical pharmacology and therapeutics vol. 114,2 (2023): 325-355. doi:10.1002/cpt.2914
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| Document Type(s): Article, |
| Countries: Europe, USA, |
| Click here for the abstract |
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Comparative Effectiveness & Health Technology Assessment, Methodology, Regulatory,
2023 |
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English
Review, |
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| Regulatory and HTA Considerations for Development of Real- World Data Derived External Controls |
| Author(s): Lesley H. Curtis (1), Oriol Sola-Morales (2), Julien Heidt (3),*, Patrick Saunders- Hastings (4), Laura Walsh (5), Deborah Casso (6),?, Susan Oliveria (7),?, Tiffany Mercado (3), Robbert Zusterzeel (3),?, Rachel E. Sobel (8), Jessica J. Jalbert (9), Vera Mastey (9), James Harnett (9) and Ruben G. W. Quek (9) |
| Affiliations(s): 1Duke Department of Population Health Sciences and Duke Clinical Research Institute, Durham, North Carolina, USA; 2Fundació HiTT and Universitat Internacional de Catalunya (UIC), Barcelona, Spain; 3IQVIA, Regulatory Science and Strategy, Falls Church, Virginia, USA; 4Epi Excellence LLC, Garnet Valley, Pennsylvania, USA; 5IQVIA, Epidemiology and Drug Safety Practice, Boston, Massachusetts, USA; 6IQVIA, Epidemiology and Drug Safety Practice, Seattle, Washington, USA; 7IQVIA, Epidemiology and Drug Safety Practice, New York, New York, USA; 8Regeneron Pharmaceuticals Inc., Pharmacoepidemiology, Tarrytown, New York, USA; 9Regeneron Pharmaceuticals Inc., Health Economics & Outcomes Research, Tarrytown, New York, USA. |
Publication(s): Clin Pharmacol Ther, 114: 303-315. https://doi.org/10.1002/cpt.2913
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| Document Type(s): Article, |
| Countries: USA, |
| Click here for the abstract |
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Comparative Effectiveness & Health Technology Assessment, Methodology, Regulatory,
2023 |
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English
Review, |
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| The CLARION study: first report on safety findings in patients newly initiating treatment with cladribine tablets or fingolimod for multiple sclerosis
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| Author(s): Helmut Butzkueven, Jan Hillert, Merja Soilu-Hänninen, Tjalf Ziemssen, Jens
Kuhle, Stig Wergeland, Melinda Magyari, Joseph R. Berger, Nicholas Moore,
Aida Aydemir, Irene Bezemer & Meritxell Sabidó
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| Affiliations(s): "a Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia;
b The Alfred Hospital, Melbourne, VIC, Australia;
c Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden;
d Turku University Hospital Neurocenter and Division of Clinical Neurosciences, University of Turku, Turku, Finland;
e Center of Clinical Neuroscience, Department of Neurology, Dresden University of Technology, Dresden, Germany;
f Multiple Sclerosis Center and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), Departments of Biomedicine and Clinical Research, University Hospital and University of Basel, Basel, Switzerland;
g Department of Neurology, University Hospital and University of Basel, Basel, Switzerland;
h Norwegian MS Registry and Biobank, Department of Neurology, Haukeland University Hospital, Bergen, Norway;
i Department of Clinical Medicine, University of Bergen, Bergen, Norway;
j Danish Multiple Sclerosis Center and the Danish Multiple Sclerosis Registry, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;
k Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA;
l Bordeaux PharmacoEpi (BPE), Universit?e de Bordeaux, Bordeaux, France;
m EMD Serono Research & Development Institute, Inc, Billerica, MA, USA, an affiliate of Merck KGaA;
n Global Epidemiology, IQVIA, Amsterdam, The Netherlands;
o Merck Healthcare KGaA, Darmstadt, Germany"
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| Publication(s): |
| Document Type(s): Article, |
| Countries: Australia, Denmark, Finland, Germany, Norway, Sweden, Switzerland, Turkey, |
| Click here for the abstract |
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Comparative Effectiveness & Health Technology Assessment, Drug safety, Neurological disorders,
2023 |
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English
clinical setting: Secondary care, Epidemiological study, Population Based Study, |
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| The emerging role of real-world data in advanced breast cancer therapy: Recommendations for collaborative decision-making
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| Author(s): Paul Cottu 1, Scott David Ramsey 2, Oriol Solà-Morales 3, Patricia A Spears 4, Lockwood Taylor 5 |
| Affiliations(s): 1Department of Medical Oncology, Institut Curie, 26 Rue D'Ulm, 75005, Paris, France. Electronic address: paul.cottu@curie.fr.
2Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, M2-B232, Seattle, WA, 98155, USA. Electronic address: sramsey@fredhutch.org.
3Health Innovation Technology Transfer Foundation, Aragó 60, E-08015, Barcelona, Spain. Electronic address: osola@fhitt.org.
48605 Carolingian Court, Raleigh, NC, 27615, USA. Electronic address: paspears88@gmail.com.
5Epidemiology, Real World Solutions at IQVIA, 4820 Emperor Boulevard, Durham, NC, 27703, USA. Electronic address: lockwood.taylor@iqvia.com. |
Publication(s): Breast. 2021 Dec 22;61:118-122. doi: 10.1016/j.breast.2021.12.015.
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| Document Type(s): Article, |
| Countries: France, Italy, USA, |
| Click here for the abstract |
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Comparative Effectiveness & Health Technology Assessment, Drug safety, Oncology, Regulatory,
2022 |
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English
Review, |
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| Evidence synthesis in pulmonary arterial hypertension: a systematic review and critical appraisal |
| Author(s): Max Schlueter, Amélie Beaudet, Evan Davies, Binu Gurung, Andreas Karabis |
| Affiliations(s): IQVIA, 210 Pentonville Road, London, N1 9JY; IQVIA, Herikerbergweg 314, 1101 CT, Amsterdam, Netherlands; Department of Statistical Science, University College London, London, WC1E 6BT, UK. |
Publication(s):
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| Document Type(s): Article, |
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| Click here for the abstract |
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Comparative Effectiveness & Health Technology Assessment, Methodology, Rare Diseases,
2020 |
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English
Literature Review, Review, |
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| Cost-utility model for 2nd generation treatment of chronic HCV in general population: impact of EASL recommendations in 2016 and 2018 |
| Author(s): Nat?lia Pascual-Argent? (1,2); Carlos Crespo (1,3); Laura Planellas (4); M?riam Solozabal (4), N?ria Perulero (4); Jaume Puig-Junoy (1,2) |
| Affiliations(s): (1) UPF Barcelona School of Management; (2) Dept. Econom?a y Empresa ? CRES UPF; (3) Universitat de Barcelona; (4) HEOR-RWE, IQVIA Spain |
Publication(s): XXXIX Jornadas de Econom?a de la Salud. Albacete, 12 al 14 de junio de 2019
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| Document Type(s): Poster, |
| Countries: Spain, |
| Click here for the abstract |
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Comparative Effectiveness & Health Technology Assessment, Health economics, Infectious disease,
2019 |
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Spanish
Clinical setting: hospital, Cost effectiveness, |
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| Assessing the Outcomes for Orphan Status or Accelerated Assessment EMA Approved Medicines: A Comparison of Health Technology Assessment in Denmark, Finland, Norway and Sweden |
| Author(s): Falla, Edel; Pitcher, Ashley; Acs, Annabel; Heller, Vincent; Zhang, Rongrong |
| Affiliations(s): IQVIA, Real-World Insights, London, LON, UK
IQVIA, Real-World Insights, Copenhagen, Denmark
IQVIA, Real-World Insights, Copenhagen, Denmark
IQVIA, Real-World Insights, Solna, AB, Sweden
IQVIA, Real-World Insights, Stockholm, Sweden |
Publication(s): ISPOR Europe 2019, November 5, 2019, Copenhagen, Denmark
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| Document Type(s): Poster, |
| Countries: Denmark, Finland, Nordic, Norway, Sweden, |
| Click here for the abstract |
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Comparative Effectiveness & Health Technology Assessment,
2019 |
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English
Review, |
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| LIMITATIONS AND EXPECTED CHALLENGES OF CAR-T ECONOMIC EVALUATION. |
| Author(s): Allou A*, Carette J*, Minacori R*, Touahmia S*, Bourguignon S*, Troubat A*, Maurel F* |
| Affiliations(s): IQVIA France - RWI |
Publication(s): ISPOR 2018
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| Document Type(s): Poster, |
| Countries: France, |
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Comparative Effectiveness & Health Technology Assessment, Health economics, Hematology,
2018 |
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English
Cost effectiveness, Market impact, Review, |
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| WHAT INTERPRETATION OF ICERS IN ORPHAN DISEASES? A FRENCH EXAMPLE. |
| Author(s): Moutier Hélène; Bourguignon Sandrine; Maurel Frédérique; Bodaghi Charles |
| Affiliations(s): RWI IQVIA France |
Publication(s): ISPOR 2018
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| Document Type(s): Poster, |
| Countries: France, |
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Comparative Effectiveness & Health Technology Assessment, Health economics, Pricing and reimbursement, Rare Diseases,
2018 |
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English
Cost effectiveness, Pricing & Reimbursement, Willingness to pay, |
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| ASSESSMENT OF THE UNIT COSTS IN IMAGING ACTS: THE EXAMPLE OF MRI AND CT-SCAN ACTS IN France |
| Author(s): Vasilescu L., Faller M., Allou A. |
| Affiliations(s): IQVIA France - RWI |
Publication(s): ISPOR 2018
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| Document Type(s): Poster, |
| Countries: France, |
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Comparative Effectiveness & Health Technology Assessment, Methodology,
2018 |
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English
Literature Review, Public Health, Review, |
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