Selection from HEOR Bibliography

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Condition: Regulatory
 
Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions
Authors: 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: (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
Publications: 
Clinical pharmacology and therapeutics vol. 114,2 (2023): 325-355. doi:10.1002/cpt.2914
Document Types: , Article
Countries: , Europe, USA
Abstract: https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1002/cpt.2914
Condition Year Language Analysis type
, Comparative Effectiveness & Health Technology Assessment, Methodology, Regulatory 2023 English , Review
 
 
Regulatory and HTA Considerations for Development of Real- World Data Derived External Controls
Authors: 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: 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.
Publications: 
Clin Pharmacol Ther, 114: 303-315. https://doi.org/10.1002/cpt.2913
Document Types: , Article
Countries: , USA
Abstract: https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1002/cpt.2913
Condition Year Language Analysis type
, Comparative Effectiveness & Health Technology Assessment, Methodology, Regulatory 2023 English , Review
 
 
The emerging role of real-world data in advanced breast cancer therapy: Recommendations for collaborative decision-making
Authors: Paul Cottu 1, Scott David Ramsey 2, Oriol Solà-Morales 3, Patricia A Spears 4, Lockwood Taylor 5
Affiliations: 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.
Publications: 
Breast. 2021 Dec 22;61:118-122. doi: 10.1016/j.breast.2021.12.015.
Document Types: , Article
Countries: , France, Italy, USA
Abstract: https://pubmed.ncbi.nlm.nih.gov/34959093/
Condition Year Language Analysis type
, Comparative Effectiveness & Health Technology Assessment, Drug safety, Oncology, Regulatory 2022 English , Review
 
 
Real-world evidence to support regulatory decision making: New or expanded medical product indications
Authors: Franklin JM, Liaw KL, Iyasu S, Critchlow CW, Dreyer NA.
Affiliations: 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.
Publications: 
Pharmacoepidemiol Drug Saf . 2021 Jun;30(6):685-693. doi: 10.1002/pds.5222. Epub 2021 Mar 18.
Document Types: , Article
Countries: , USA
Abstract: https://pubmed.ncbi.nlm.nih.gov/33675248/
Condition Year Language Analysis type
, Guidelines, Regulatory 2021 English , Real World Data, Real World Evidence
 
 
Bridging the Gap Between RCTs and RWE Through Endpoint Selection
Authors: 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: 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.
Publications: 
Ther Innov Regul Sci . 2021 Jan;55(1):90-96. doi: 10.1007/s43441-020-00193-5. Epub 2020 Jul 6.
Document Types: , Article
Countries: , USA
Abstract: https://doi.org/10.1007/s43441-020-00193-5
Condition Year Language Analysis type
, Regulatory 2021 English , Real World Data, Real World Evidence
 
 
When Can We Trust Real-World Data To Evaluate New Medical Treatments?
Authors: 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: 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.
Publications: 
Clinical Pharmacology & Therapeutics 2022; 111(1):24-29, 2022/1
Document Types: , Article
Countries: , USA
Abstract: https://pubmed.ncbi.nlm.nih.gov/33932030/
Condition Year Language Analysis type
, Regulatory 2021 English , Real World Data
 
 
The impact of the new innovative algorithm in Italy
Authors: Rova A1, Cioni L1, Urbinati D1
Affiliations: 1 IQVIA, RWI, Milan, Italy
Publications: 
ISPOR 21st Annual European Congress, 10-14 November 2018, Barcelona, Spain
Document Types: , Poster
Countries: , Italy
Condition Year Language Analysis type
, Health policy, Public Health, Regulatory 2018 English
 
 
The evolution of standard monitoring registries in the Italian market
Authors: Cioni L1, Rova A1, Urbinati D1
Affiliations: 1 IQVIA, RWI, Milan, Italy
Publications: 
ISPOR 21st Annual European Congress, 10-14 November 2018, Barcelona, Spain
Document Types: , Poster
Countries: , Italy
Condition Year Language Analysis type
, Health policy, Public Health, Regulatory 2018 English
 
 
Off-Label Prescription of Drugs Compared to Prescription After Label Extension in Children for Germany
Authors: Gohlke A, Kostev K, Kuschel AS
Affiliations: IQVIA Commercial GmbH & Co. OHG, Munich, Germany
Publications: 
Document Types: 
Countries: 
Condition Year Language Analysis type
, Health policy, Pediatrics, Regulatory 2018 English , Utility analysis
 
 
The impact of managed entry agreements on drug time to market in Italy
Authors: Mantuano M1, Rova A1, Urbinati D1
Affiliations: 1 QuintilesIMS, Milan, Italy
Publications: 
ISPOR 20th Annual European Congress, 4-8 November 2017, Glasgow, Scotland
Document Types: , Poster
Countries: , Italy
Condition Year Language Analysis type
, Health policy, Regulatory 2017 English , Literature Review
 
 
The impact of biosimilar launch on molecule price and pharmaceutical expense: the case of the insulin glargine in Italy
Authors: Tucci C1, Cioni L1, Mantuano M1, Tettamanti A1
Affiliations: 1 QuintilesIMS, Milan, Italy
Publications: 
ISPOR 20th Annual European Congress, 4-8 November 2017, Glasgow, Scotland
Document Types: , Poster
Countries: , Italy
Condition Year Language Analysis type
, Diabetes, Health policy, Pricing and reimbursement, Regulatory 2017 English , Literature Review, Pricing & Reimbursement, Public Health
 
 
Drug commercialization before the pricing and reimbursement in Italy: the non negotiated C Class (C-nn)
Authors: Mantuano M1, Cioni L1
Affiliations: 1 QuintilesIMS, Milan, Italy
Publications: 
ISPOR 20th Annual European Congress, 4-8 November 2017, Glasgow, Scotland
Document Types: , Poster
Countries: , Italy
Condition Year Language Analysis type
, Health policy, Pricing and reimbursement, Regulatory 2017 English , Literature Review, Pricing & Reimbursement, Public Health
 
 
Centralization and complexity of drug market access process across Italian regions
Authors: Tucci C1, Cioni L1, Mantuano M1, Urbinati D1
Affiliations: QuintilesIMS, Milan, Italy
Publications: 
ISPOR 20th Annual European Congress, 4-8 November 2017, Glasgow, Scotland
Document Types: , Poster
Countries: , Italy
Condition Year Language Analysis type
, Health policy, Public Health, Regulatory 2017 English , Literature Review, Public Health, Survey research
 
 
Regional market access pathways for diagnostics in Italy.
Authors: Mantuano M1, Dionisi M2, Paolini D2, Gancitano G2, Urbinati D1
Affiliations: 1 IMS Health, Milan, Italy 2 Roche Diagnostics, Italy.
Publications: 
ISPOR 19th Annual European Congress, 2016, 29 October-2 November, Vienna, Austria.
Document Types: , Poster
Countries: , Italy
Condition Year Language Analysis type
, Health policy, Pricing and reimbursement, Regulatory 2016 English , Review
 
 
Between Risk Management and Pharmacoepidemiology: Where Do Post-Authorisation Safety Studies Stand Today?
Authors: Mariana F. Almas1, Pierre Engel2, Marieke L. De Bruin3, Kathryn Starzyk4, Blackburn Stella1 and Dreyer A. Nancy5
Affiliations: 1Real-World & Late Phase Research, Reading, Berkshirek, United Kingdom; 2Real-World & Late Phase Research, France; 3Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, Netherlands; 4Real-World & Late Phase Research, Cambridge, United States; 5University of North Carolina, Chapel Hill, United States
Publications: 
Document Types: , Abstract
Countries: 
Abstract: https://onlinelibrary.wiley.com/doi/full/10.1002/pds.4070
Condition Year Language Analysis type
, Drug safety, Regulatory, Risk Management & REMS 2016 English , Review
 
 
Prevention of venous thromboembolic events by fondaparinux 2.5mg in general practice. ArchiMed Ville
Authors: Mahé I1, Daurès JP2, Pouchain D3, Quéré I4, Aubin C5, Doussaint J6, Schück S6, Leroyer C7
Affiliations: 1EA 7334 méthodologies et société (REMES), hôpital Louis-Mourier, université Paris 7, AP-HP, 178, rue des Renouillers, 92700 Colombes, France. 2IURC de Montpellier, 641, avenue du Doyen-Gaston-Giraud, 34093 Montpellier cedex, France; CHU de Nîmes, 30029 Nîmes, France. 3Département de médecine générale, UFR Tours, 10, boulevard Tonnellé, BP 3223, 37032 Tours cedex 1, France. 4Hôpital Saint-Eloi, CHRU de Montpellier, 80, avenue Augustin-Fliche, 34295 Montpellier cedex 5, France. 5Laboratoire GlaxoSmithKline, 100, route de Versailles, 78160 Marly-le-roi, France. 6Kappa Santé, 4, rue de Cléry, 75002 Paris, France. 7Département de médecine interne et de pneumologie, université européenne de Bretagne, CHU de la Cavale-Blanche, boulevard Tanguy-Prigent, 29609 Brest cedex, France
Publications: 
J Mal Vasc. 2015 Jul 20. pii: S0398-0499(15)00121-3
Document Types: , Article
Countries: , France
Condition Year Language Analysis type
, Cardiovascular disease, Drug Utlization Study, Orthopedics, Regulatory, Vascular disease 2015 English , Prospective study
 
 
Understanding patterns of monitoring of appropriate prescribing in Europe
Authors: Schroeder C1, Keja J2, Toussi M3, Hughes B2
Affiliations: 1 IMS Health, Munich, Germany 2 IMS Health, London, UK 3 IMS Health, Paris, France
Publications: 
ISPOR 16th annual european congress, 2013, November 2-6, Dublin, Ireland
Document Types: , Poster
Countries: , Europe
Condition Year Language Analysis type
, Health policy, Regulatory 2013 English , Review
 
 
Integrating HTA requirements into drug development
Authors: Lloyd A
Affiliations: IMS Health, London, UK
Publications: 
Drug Information Agency 23rd Annual EuroMeeting, Gevena Switzerland, 29 March 2011
Document Types: , Workshop
Countries: , UK
Condition Year Language Analysis type
, Regulatory 2011 English , Compliance
 
 
An assessment of the impact of the coverage gap upon medicare part D beneficiaries utilizing insulin
Authors: Skrepnek GH, Denarie MF, Conner C, Forma FM
Affiliations: 
Publications: 
ISPOR 2008 13th Annual International Congress
Document Types: , Poster
Countries: 
Condition Year Language Analysis type
, Regulatory 2008 English , Burden of illness
 
 
Health behavior change: leading models and their practical application.
Authors: Schabert VF1, Drane A
Affiliations: 1 IMS Health, Falls Church, VA, US
Publications: 
ISPOR 13th Annual International Meeting, Toronto, ON, Canada, May 3-7, 2008
ISPOR 2008 13th Annual International Congress
Document Types: , Tutorial, Workshop
Countries: , USA
Condition Year Language Analysis type
, Mental health, Regulatory 2008 English , Methodology, Workshop
 
 
Steuerungsinstrumente in der Arzneimittelversorgung [Steering instruments of drug supply]
Authors: Fricke F-U
Affiliations: IMS Health, Nuremberg, Germany
Publications: 
Schöffski O, Fricke F-U, Guminski W (ed.). Pharmabetriebslehre, Berlin-Heidelberg, Springer, 2008, 47-72
Document Types: , Book chapter
Countries: 
Condition Year Language Analysis type
, Regulatory 2008 German , Methodology
 
 
Mental health reform in the Russian Federation: an integrated approach to achieve social inclusion and recovery
Authors: Jenkins R1, Lancashire S1, McDaid D2, Samyshkin Y3, Green S1, Watkins J1, Potasheva A4, Nikiforov A5, Bobylova Z4, Gafurov V6, Goldberg D1, Huxley P7, Lucas J8, Purchase N1, Atuni R9
Affiliations: 1 Institute of Psychiatry, Kings College London, England 2 London School of Economics and Political Science, London, England 3 IMS Health, London, England 4 Sverdlovsk Oblast Ministry of Health. Ekaterinburg, Russia 5 Sverdlovsk Oblast Ministry of Social Protection, Ekaterinburg, Russia 6 AMH Project, Ekaterinburg, Russia 7 Department of Applied Social Studies, University of Swansea, Swansea, England 8 Kastanja Consulting, London, England 9 Imperial College, London, England IXImperial College, London, England
Publications: 
World Health Organization 2007;85:858–866.
Document Types: , Article
Countries: , Russian Federation
Abstract: http://www.who.int/entity/bulletin/volumes/85/11/06-039156/en/index.html
Condition Year Language Analysis type
, Regulatory 2007 English , Observational study
 
 
Working with IQWiG (Institute for Quality and Economic Efficiency in Health Care)
Authors: Fricke FU
Affiliations: IMS Health, Nuremberg, Germany
Publications: 
Pharmaceutical Executive Magazine Europe, 2007, Nov/Dec: pp. 24-26
Document Types: , Article
Countries: , Germany
Condition Year Language Analysis type
, Regulatory 2007 English , Pricing & Reimbursement
 
 
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