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) FundaciĆ³ 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
Document Type(s): Article,
Countries: Europe, USA,
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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; 2FundaciĆ³ 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
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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How well can we assess the validity of non-randomised studies of medications? A systematic review of assessment tools
Author(s): Elvira D'Andrea, Lydia Vinals, Elisabetta Patorno, Jessica M. Franklin, Dimitri Bennett , Joan A. Largent, Daniela C. Moga, Hongbo Yuan, Xuerong Wen, Andrew R. Zullo, Thomas P. A. Debray, Grammati Sarri
Affiliations(s): D'Andrea: Harvard; Largent: IQVIA
Publication(s):  http://orcid.org/0000-0002-5263-3964PubMed articles
Document Type(s): Article,
Countries: Europe, USA,
Click here for the abstract
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Methodology,
2021
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English
Literature Review,
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Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making
Author(s): Grammati Sarri 1, Elisabetta Patorno 2, Hongbo Yuan 3, Jianfei Jeff Guo 4, Dimitri Bennett 5, Xuerong Wen 6, Andrew R Zullo 7, Joan Largent 8, Mary Panaccio 9, Mugdha Gokhale 10, Daniela Claudia Moga 11, M Sanni Ali 12 13 14, Thomas P A Debray 15 16
Affiliations(s): 1Real World Evidence Sciences, Visible Analytics Ltd, Oxford, UK grammati.sarri@visibleanalytics.co.uk. 2Division of Pharmacoepidemiology and Pharmacoeconomics, Dept. of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. 3Canadian Agency for Drugs and Technologies in Health (CADTH), Ottawa, Ontario, Canada. 4Department of Pharmacy Practice & Administrative Sciences, University of Cincinnati College of Pharmacy, Cincinnati, Ohio, USA. 5Takeda, Cambridge, Massachusetts, USA. 6Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, Rhode Island, USA. 7Health Services, Policy, and Practice, Brown University, Providence, Rhode Island, USA. 8Real-World Solutions, IQVIA, California, Colorado, USA. 9Epidemiology and Outcomes Research, Research Outcomes Innovations LLC, New York City, New York, USA. 10GlaxoSmithKline USA, Philadelphia, Pennsylvania, USA. 11University of Kentucky, Department of Pharmacy Practice and Science, Lexington, Kentucky, USA. 12NDORMS, Center for Statistics in Medicine, University of Oxford, Oxford, UK. 13Department of Non-communicable Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine (LSHTM), London, UK. 14Department of Public Heath, Environments and Society, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine (LSHTM), London, UK. 15Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands. 16Smart Data Analysis and Statistics, Utrecht, The Netherlands.
Publication(s):  PMID: 33298465 DOI: 10.1136/bmjebm-2020-111493
Document Type(s): Article,
Countries: Europe, USA,
Click here for the abstract
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Methodology,
2021
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English
Literature Review,
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Clinical and Economic Burden of Mild-to-Moderate Atopic Dermatitis in the UK: A Propensity-Score-Matched Case-Control Study
Author(s): Farah Toron 1, Maureen P Neary 2, Timothy W Smith 3, David Gruben 4, William Romero 5, Amy Cha 3, Keyur Patel 1, Simona Z Vasileva 6, Mahreen Ameen 7
Affiliations(s): 1Health Economics and Outcomes Research, Real World Solutions, IQVIA, 210 Pentonville Road, London, N1 9JY, UK. 2Inflammation & Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA. 3Inflammation & Immunology, Pfizer Inc, New York, New York, USA. 4Global Biometrics and Data Management (Statistics), Pfizer Inc, Groton, Connecticut, USA. 5Inflammation & Immunology, Pfizer Ltd, Surrey, UK. 6Health Economics and Outcomes Research, Real World Solutions, IQVIA, 210 Pentonville Road, London, N1 9JY, UK. simona.vasileva@iqvia.com. 7Royal Free London National Health Services Foundation Trust, London, UK.
Publication(s):  PMID: 33846907 PMCID: PMC8163940 DOI: 10.1007/s13555-021-00519-7
Document Type(s): Article,
Countries: UK,
Click here for the abstract
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Dermatology, Drug Utlization Study, Methodology,
2021
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English
direct to patient research, direct-to-patient research, Economic evaluation, Population Based Study, Retrospective database analysis,
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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.
Document Type(s): Article,
Countries: Europe,
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Guidelines, Methodology, Risk Management & REMS,
2021
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English
Literature Review,
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Comparison of ICD-9-CM to ICD-10-CM Crosswalks Derived by Physician and Clinical Coder vs. Automated Methods
Author(s): Jason C Simeone, Xinyue Liu, Tarun Bhagnani, Matthew W Reynolds, Jenna Collins, Edward A Bortnichak
Affiliations(s): CAEG
Publication(s):  Perspective Health Information Management 2021 Mar 15;18(Spring):1e.
Document Type(s): Article,
Countries: USA,
Click here for the abstract
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Methodology,
2021
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English
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When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments?
Author(s): Jessica M Franklin 1 2, Richard Platt 3, Nancy A Dreyer 4, Alex John London 5, Gregory E Simon 6, Jonathan H Watanabe 7, Michael Horberg 8, Adrian Hernandez 9, Robert M Califf 10
Affiliations(s): 1Optum Epidemiology, Boston, Massachusetts, USA. 2Division of Pharmacoepidemiology & Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. 3Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, Massachusetts, USA. 4IQVIA Real World Solutions, Cambridge, Massachusetts, USA. 5Philosophy Department & Center for Ethics and Policy, Carnegie Mellon University, Pittsburgh, Pennsylvania, USA. 6Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA. 7School of Pharmacy and Pharmaceutical Sciences, University of California Irvine, Irvine, California, USA. 8Kaiser Permanente Mid-Atlantic Permanente Research Institute and Mid-Atlantic Permanente Medical Group, Bethesda, Maryland, USA. 9Duke Clinical Research Institute, Durham, North Carolina, USA. 10Verily Life Sciences and Google Health, Cambridge, Massachusetts, USA.
Publication(s):  Clinical Pharmacology & Therapeutics. 2021 Apr 7.
Document Type(s): Article,
Countries: USA,
Click here for the abstract
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Methodology,
2021
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English
Real World Data,
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Uncontrolled Extensions of Clinical Trials and the Use of External Controls?scoping opportunities and methods.
Author(s): Ching-Yu Wang 1, Jesse A Berlin 2, Barry Gertz 3, Kourtney Davis 4, Jie Li 5, Nancy A Dreyer 6, Wei Zhou 7, John D Seeger 8, Nancy Santanello 9, Almut G Winterstein 1
Affiliations(s): 1Pharmaceutical Outcomes & Policy, Center for Drug Evaluation & Safety, University of Florida, Gainesville, Florida, USA. 2Epidemiology, Johnson & Johnson, Titusville, New Jersey, USA. 3Blackstone Life Sciences, Cambridge, Massachusetts, USA. 4Global Epidemiology, Janssen R&D, Titusville, New Jersey, USA. 5US Food and Drug Administration, Silver Spring, Maryland, USA. 6Real-World Solutions, IQVIA, Cambridge, Massachusetts, USA. 7Merck & Co., Inc., Kenilworth, New Jersey, USA. 8Optum, Boston, Massachusetts, USA. 9Pharmacoepidemiology Consultant, New Hope, Pennsylvania, USA.
Publication(s):  Clinical Pharmacology & Therapeutics. 2021 Jun 24.
Document Type(s): Article,
Countries: USA,
Click here for the abstract
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Methodology,
2021
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English
Real World Data,
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A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe
Author(s): Laurence Sophie Jouaville 1, Tulika Paul 2, Mariana Ferreira Almas
Affiliations(s): QVIA Real World Solutions, La Defense, France. 2IQVIA Real World Solutions, Gurugram, Haryana, India. 3IQVIA Real World Solutions, Porto Salvo, Portugal.
Publication(s):  Pharmacoepidemiol Drug Saf . 2021 Sep;30(9):1143-1152. doi: 10.1002/pds.5301. Epub 2021 Jun 24.
Document Type(s): Article,
Countries: 
Click here for the abstract
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Methodology, Risk Management & REMS,
2021
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English
Database Study,
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