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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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| Assessing definitions and incentives adopted for innovation for pharmaceutical products in five high-income countries: a systematic literature review |
| Author(s): Naohiko Wakutsu 1, Emi Hirose 2, Naohiro Yonemoto 3, Sven Demiya 4 (rwesheorj 4) |
| Affiliations(s): 1) Graduate School of Economics, Nagoya City University, Nagoya, Japan
2) Health & Value, Pfizer Japan Inc., Tokyo, Japan. emi.hirose@pfizer.com
3) Health & Value, Pfizer Japan Inc., Tokyo, Japan
4) IQVIA Solutions Japan K.K., Tokyo, Japan |
Publication(s): Pharmaceutical Medicine
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| Document Type(s): Article, |
| Countries: France, Germany, Japan, UK, USA, |
| Click here for the abstract |
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Miscellaneous,
2023 |
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English
Literature Review, |
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| Comparison of depression trends in the Japanese and US populations before and during the COVID-19 pandemic: a retrospective observational study using real-world data |
| Author(s): Sven Demiya 1, Shujiro Takeno 1, Louis P. Watanabe 1, Wen Shi Lee 1, Yuri Sakai 1, Todd D. Taylor 1, Seok-Won Kim 1 (rwesheorj 1) |
| Affiliations(s): 1) IQVIA Solutions Japan KK, Tokyo Japan |
Publication(s): Value & Outcomes Spotlight
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| Document Type(s): Article, |
| Countries: Japan, USA, |
| Click here for the abstract |
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Mental health,
2023 |
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English
Database Study, Observational study, Retrospective database analysis, |
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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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| Georgraphic Variation in the Use of Gabapentinoids and Opioids for Pain in a Commercially Insured Adult Population in the United States |
| Author(s): Danni Zhao, Jonggyu Baek, Anne L Hume, Emily A McPhillips, and Kate L Lapane
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| Affiliations(s): 1Department of Population and Quantitative Health Sciences, UMass Chan Medical School, Worcester, MA, USA.
2Department of Family Medicine, Alpert Medical School, Brown University, Memorial Hospital of Rhode Island, Providence, RI, USA.
3Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, RI, USA. |
Publication(s): J Pain Res
. 2022 Feb 11;15:443-454. doi: 10.2147/JPR.S345521. eCollection 2022.
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| Document Type(s): Article, |
| Countries: USA, |
| Click here for the abstract |
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Drug Utlization Study, Pain,
2022 |
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English
Epidemiological study, Observational study, Public Health, |
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| Validation of safety outcomes in routinely collected data: lessons learned from a multinational post-approval safety study
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| Author(s): Arena PJ, Huang K, Löfling L, Bahmanyar S, Mo J, Schachterle SE, Nunes AP, Smits E, Juuti R, Hoti F, Korhonen P, Adelborg K, Sundbøll J, Rasmussen TR, Løkke A, Ehrenstein V.
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| Affiliations(s): "Pfizer Inc., New York, New York, United States of America.
Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, California, United States of America.
EPID Research (an IQVIA company), Espoo, Finland."
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Publication(s): Pharmacoepidemiol Drug Saf. 2022 Dec 10. doi: 10.1002/pds.5582
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| Document Type(s): Article, |
| Countries: Denmark, Finland, Netherlands , Sweden, USA, |
| Click here for the abstract |
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Database Validity and methodology, Drug safety, Oncology,
2022 |
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English
Clinical setting: hospital, Clinical setting: Primary care, clinical setting: Secondary care, Retrospective database analysis, |
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| Prevalence of depression in Japan and the US populations before and during the COVID-19 pandemic: a retrospective observational study using real-world data |
| Author(s): Demiya S 1, Takeno S 1, Kim SW 2, Lee WS 3, Sakai Y 1 (rwesheorj 1-3) |
| Affiliations(s): 1) IQVIA Solutions Japan, Tokyo, Japan
2) IQVIA Solutions Japan, Tokyo, 13, Japan
3) IQVIA Solutions Japan, Tokyo, 12, Japan |
Publication(s): ISPOR Europe
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| Document Type(s): Conference, Poster, Presentation, |
| Countries: Japan, USA, |
| Click here for the abstract |
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Mental health,
2022 |
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English
Database Study, Retrospective database analysis, |
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| Leveraging unstructured data to identify hereditary angioedema patients in electronic medical records |
| Author(s): Emily S Brouwer 1 , Emily W Bratton 2 , Aimee M Near 2 , Lynn Sanders 1 , Christina D Mack 2 |
| Affiliations(s): 1 Takeda Pharmaceutical Company Limited, 300 Shire Way, Lexington, MA, USA.
2 IQVIA, Durham, NC, USA. |
Publication(s): Allergy Asthma Clin Immunol
. 2021 Apr 20;17(1):41. doi: 10.1186/s13223-021-00541-6.
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| Document Type(s): Article, |
| Countries: USA, |
| Click here for the abstract |
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Rare disease,
2021 |
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English
Clinical setting: Primary care, clinical setting: Secondary care, Epidemiological study, Observational study, Retrospective database analysis, |
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| Epidemiology of Concussion in the National Football League, 2015-2019
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| Author(s): Christina D Mack 1, Gary Solomon 2 3, Tracey Covassin 4, Nicholas Theodore 5, Javier Cárdenas 6, Allen Sills 2 3 |
| Affiliations(s): 1 IQVIA, Durham, NC, USA.
2 Department of Neurological Surgery and Vanderbilt Sports Concussion Center, Vanderbilt University School of Medicine, Nashville, Tennessee
3 National Football League Player Health and Safety Department, New York, New York
4 Department of Kinesiology, Michigan State University, East Lansing, Michigan
5 Department of Neurological Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland
6 Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona |
Publication(s): Sports Health
. 2021 Apr 19;19417381211011446. doi: 10.1177/19417381211011446.
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| Document Type(s): Article, |
| Countries: USA, |
| Click here for the abstract |
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Injuries,
2021 |
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English
Epidemiological study, Observational study, Retrospective database analysis, |
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