423 related articles for article (PubMed ID: 34148219)
21. Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions.
Li P; Wang S; Chen Y
Ther Innov Regul Sci; 2023 Nov; 57(6):1167-1179. PubMed ID: 37624556
[TBL] [Abstract][Full Text] [Related]
22. Using Real-World Data in the Health Technology Assessment of Pharmaceuticals: Strengths, Difficulties, and a Pragmatic Way Forward.
Akehurst R; Murphy LA; Solà-Morales O; Cunningham D; Mestre-Ferrandiz J; de Pouvourville G
Value Health; 2023 Apr; 26(4S):11-19. PubMed ID: 36706952
[TBL] [Abstract][Full Text] [Related]
23. Can we use existing guidance to support the development of robust real-world evidence for health technology assessment/payer decision-making?
Capkun G; Corry S; Dowling O; Asad Zadeh Vosta Kolaei F; Takyar S; Furtado C; Jónsson P; Kleinermans D; Lambert L; Schiel A; Facey K
Int J Technol Assess Health Care; 2022 Nov; 38(1):e79. PubMed ID: 36321447
[TBL] [Abstract][Full Text] [Related]
24. Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan.
Maeda H; Ng DB
Front Med (Lausanne); 2022; 9():864960. PubMed ID: 35492312
[TBL] [Abstract][Full Text] [Related]
25. Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey.
Facile R; Muhlbradt EE; Gong M; Li Q; Popat V; Pétavy F; Cornet R; Ruan Y; Koide D; Saito TI; Hume S; Rockhold F; Bao W; Dubman S; Jauregui Wurst B
JMIR Med Inform; 2022 Jan; 10(1):e30363. PubMed ID: 35084343
[TBL] [Abstract][Full Text] [Related]
26. Comparison of two assessments of real-world data and real-world evidence for regulatory decision-making.
Yuan L; Rahman M; Concato J
Clin Transl Sci; 2024 Jan; 17(1):e13702. PubMed ID: 38093484
[TBL] [Abstract][Full Text] [Related]
27. Current status of real-world big data research in the cardiovascular field in Japan.
Tonegawa-Kuji R; Kanaoka K; Iwanaga Y
J Cardiol; 2023 Mar; 81(3):307-315. PubMed ID: 36126909
[TBL] [Abstract][Full Text] [Related]
28. A systematic review of real-world evidence (RWE) supportive of new drug and biologic license application approvals in rare diseases.
Vaghela S; Tanni KA; Banerjee G; Sikirica V
Orphanet J Rare Dis; 2024 Mar; 19(1):117. PubMed ID: 38475874
[TBL] [Abstract][Full Text] [Related]
29. Use of real-world evidence in regulatory decisions for rare diseases in the United States-Current status and future directions.
Wu J; Wang C; Toh S; Pisa FE; Bauer L
Pharmacoepidemiol Drug Saf; 2020 Oct; 29(10):1213-1218. PubMed ID: 32003065
[TBL] [Abstract][Full Text] [Related]
30. Real-World Evidence: A Primer.
Dang A
Pharmaceut Med; 2023 Jan; 37(1):25-36. PubMed ID: 36604368
[TBL] [Abstract][Full Text] [Related]
31. Use of real-world data and evidence for medical devices: a qualitative study of key informant interviews.
Polisena J; Jayaraman G
Int J Technol Assess Health Care; 2020 Dec; 36(6):579-584. PubMed ID: 33161916
[TBL] [Abstract][Full Text] [Related]
32. The role of Real-World Data and evidence in oncology medicines approved in EU in 2018-2019.
Eskola SM; Leufkens HGM; Bate A; De Bruin ML; Gardarsdottir H
J Cancer Policy; 2023 Jun; 36():100424. PubMed ID: 37116794
[TBL] [Abstract][Full Text] [Related]
33. Do existing real-world data sources generate suitable evidence for the HTA of medical devices in Europe? Mapping and critical appraisal.
Pongiglione B; Torbica A; Blommestein H; de Groot S; Ciani O; Walker S; Dams F; Blankart R; Mollenkamp M; Kovács S; Tarricone R; Drummond M
Int J Technol Assess Health Care; 2021 Apr; 37(1):e62. PubMed ID: 33896433
[TBL] [Abstract][Full Text] [Related]
34. Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation.
Breckenridge AM; Breckenridge RA; Peck CC
Br J Clin Pharmacol; 2019 Sep; 85(9):1874-1877. PubMed ID: 31290181
[TBL] [Abstract][Full Text] [Related]
35. Harnessing Real-World Data for Regulatory Use and Applying Innovative Applications.
Zou KH; Li JZ; Imperato J; Potkar CN; Sethi N; Edwards J; Ray A
J Multidiscip Healthc; 2020; 13():671-679. PubMed ID: 32801731
[TBL] [Abstract][Full Text] [Related]
36. Real world data and data science in medical research: present and future.
Togo K; Yonemoto N
Jpn J Stat Data Sci; 2022; 5(2):769-781. PubMed ID: 35437515
[TBL] [Abstract][Full Text] [Related]
37. Appropriate Relevancy and Reliability of Real-World Data for the Utilization of Regulatory Submission.
Bando H; Misumi T; Sakamoto Y; Takeda Y; Nakamura Y; Mizuguchi K; Aoyagi Y; Miki I; Kuroda T; Kasai R; Suzuki T; Yoshino T; Ohtsu A
Clin Colorectal Cancer; 2024 Jun; 23(2):111-117. PubMed ID: 38679555
[TBL] [Abstract][Full Text] [Related]
38. A national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making.
Mikl V; Baltic D; Czypionka T; Degelsegger-Márquez A; Forgó N; Gouya-Lechner G; Herzog A; Klimek P; Lumenta DB; Mraz B; Ostermann H; Scharinger R; Stamm T; Strassnig M; Zeitlinger M; Pleiner-Duxneuner J
Sci Rep; 2024 Apr; 14(1):9751. PubMed ID: 38679653
[TBL] [Abstract][Full Text] [Related]
39. [The application of real-world evidence in drug regulatory decision-making].
Wicherski J; Haenisch B
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2024 Feb; 67(2):149-154. PubMed ID: 38214723
[TBL] [Abstract][Full Text] [Related]
40. Mapping Canadian Data Assets to Generate Real-World Evidence: Lessons Learned from Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration's RWE Data Working Group.
Dai WF; de Oliveira C; Blommaert S; Pataky RE; Tran D; Aurangzeb Z; Kendell C; Folkins C; Somayaji C; Dowden J; Cheung W; Strumpf E; Beca JM; McClure C; Urquhart R; McDonald JT; Alvi R; Turner D; Peacock S; Denburg A; Mercer RE; Muñoz C; Parmar A; Tadrous M; Takhar P; Chan KKW; On Behalf Of The CanREValue Collaboration
Curr Oncol; 2022 Mar; 29(3):2046-2063. PubMed ID: 35323365
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
