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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 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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| 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 |
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Guidelines, Regulatory,
2021 |
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English
Real World Data, Real World Evidence, |
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| Bridging the Gap Between RCTs and RWE Through Endpoint Selection |
| Author(s): Robert J LoCasale 1, Chris L Pashos 2, Ben Gutierrez 3, Nancy A Dreyer 4, Toby Collins 5, Alan Calleja 5, Michael J Seewald 6, Jonathan M Plumb 7, Johan Liwing 8, Maurille Feudjo Tepie 9, Sajan Khosla 10 |
| Affiliations(s): 1Real World Evidence, Sanofi, Bridgewater, NJ, USA.
2AbbVie, Chicago, IL, USA.
3GSK, Philadelphia, PA, USA.
4IQVIA, Real-World Solutions, Cambridge, MA, USA.
5IQVIA, Real-World Solutions, London, UK.
6Novartis Pharma AG/Pharma Medical Affairs, Basel, Switzerland.
7Ferring Pharmaceuticals SA, St Prex, Switzerland.
8CellProtect Nordic Pharmaceuticals, Stockholm, Sweden.
9Center for Observational Research, Amgen, Cambridge, UK.
10Real-World Evidence Center of Excellence, AstraZeneca, Cambridge, UK. sajan.khosla@astrazeneca.com. |
Publication(s): Ther Innov Regul Sci
. 2021 Jan;55(1):90-96. doi: 10.1007/s43441-020-00193-5. Epub 2020 Jul 6.
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| Document Type(s): Article, |
| Countries: USA, |
| Click here for the abstract |
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Regulatory,
2021 |
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English
Real World Data, Real World Evidence, |
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| When Can We Trust Real-World Data To Evaluate New Medical Treatments? |
| Author(s): Gregory E Simon 1, Andrew B Bindman 2, Nancy A Dreyer 3, Richard Platt 4, Jonathan H Watanabe 5, Michael Horberg 6, Adrian Hernandez 7, Robert M Califf 8 |
| Affiliations(s): 1Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
2Kaiser Foundation Health Plan and Hospitals, Redwood City, California, USA.
3IQVIA Real World Solutions, Durham, North Carolina, USA.
4Harvard Pilgrim Health Care Institute and Harvard Medical School, Hartford, Connecticut, USA.
5University of California Irvine School of Pharmacy and Pharmaceutical Sciences, Irvine, California, USA.
6Kaiser Permanente Mid-Atlantic Permanente Research Institute and Mid-Atlantic Permanente Medical Group, Rockville, Maryland, USA.
7Duke Clinical Research Institute, Durham, North Carolina, USA.
8Verily Life Sciences and Google Health, South San Francisco, California, USA. |
Publication(s): Clinical Pharmacology & Therapeutics 2022; 111(1):24-29, 2022/1
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| Document Type(s): Article, |
| Countries: USA, |
| Click here for the abstract |
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Regulatory,
2021 |
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English
Real World Data, |
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| The impact of the new innovative algorithm in Italy |
| Author(s): Rova A1, Cioni L1, Urbinati D1 |
| Affiliations(s): 1 IQVIA, RWI, Milan, Italy |
Publication(s): ISPOR 21st Annual European Congress, 10-14 November 2018, Barcelona, Spain
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| Document Type(s): Poster, |
| Countries: Italy, |
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Health policy, Public Health, Regulatory,
2018 |
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English
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| The evolution of standard monitoring registries in the Italian market |
| Author(s): Cioni L1, Rova A1, Urbinati D1 |
| Affiliations(s): 1 IQVIA, RWI, Milan, Italy |
Publication(s): ISPOR 21st Annual European Congress, 10-14 November 2018, Barcelona, Spain
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| Document Type(s): Poster, |
| Countries: Italy, |
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Health policy, Public Health, Regulatory,
2018 |
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English
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| Off-Label Prescription of Drugs Compared to Prescription After Label Extension in Children for Germany |
| Author(s): Gohlke A, Kostev K, Kuschel AS |
| Affiliations(s): IQVIA Commercial GmbH & Co. OHG, Munich, Germany |
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Health policy, Pediatrics, Regulatory,
2018 |
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English
Utility analysis, |
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| The impact of managed entry agreements on drug time to market in Italy |
| Author(s): Mantuano M1, Rova A1, Urbinati D1 |
| Affiliations(s): 1 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, |
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Health policy, Regulatory,
2017 |
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English
Literature Review, |
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