178 related articles for article (PubMed ID: 33587541)
1. Leveraging Real-World Evidence: A Paradigm Shift in Regulation.
De S; Larson L; Kelly K; Hanson B; Mack CD
J Orthop Trauma; 2021 Mar; 35(Suppl 1):S13-S16. PubMed ID: 33587541
[TBL] [Abstract][Full Text] [Related]
2. Trial designs using real-world data: The changing landscape of the regulatory approval process.
Baumfeld Andre E; Reynolds R; Caubel P; Azoulay L; Dreyer NA
Pharmacoepidemiol Drug Saf; 2020 Oct; 29(10):1201-1212. PubMed ID: 31823482
[TBL] [Abstract][Full Text] [Related]
3. Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World.
Burns L; Roux NL; Kalesnik-Orszulak R; Christian J; Hukkelhoven M; Rockhold F; O'Donnell J
Clin Ther; 2022 Mar; 44(3):420-437. PubMed ID: 35181179
[TBL] [Abstract][Full Text] [Related]
4. 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]
5. Real World-Evidence for Regulatory Use Decision Aid: An Interactive Tool To Inform Clinical Development and Regulatory Strategies.
Burns L; Kalesnik-Orszulak R; Spring R; Zeegers F; Rutstein M; Hukkelhoven M; Wruck L; O'Donnell J
Adv Ther; 2022 Oct; 39(10):4772-4778. PubMed ID: 35972721
[TBL] [Abstract][Full Text] [Related]
6. 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]
7. 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]
8. Use of Real-World Evidence for Regulatory Approval and Coverage of Medical Devices: A Landscape Assessment.
Timbie JW; Kim AY; Concannon TW
Value Health; 2021 Dec; 24(12):1792-1798. PubMed ID: 34838277
[TBL] [Abstract][Full Text] [Related]
9. The Case for Real-world Evidence in the Future of Clinical Research on Chronic Myeloid Leukemia.
Webster J; Smith BD
Clin Ther; 2019 Feb; 41(2):336-349. PubMed ID: 30709609
[TBL] [Abstract][Full Text] [Related]
10. Understanding Use of Real-World Data and Real-World Evidence to Support Regulatory Decisions on Medical Product Effectiveness.
Mahendraratnam N; Mercon K; Gill M; Benzing L; McClellan MB
Clin Pharmacol Ther; 2022 Jan; 111(1):150-154. PubMed ID: 33891318
[TBL] [Abstract][Full Text] [Related]
11. Online tools to synthesize real-world evidence of comparative effectiveness research to enhance formulary decision making.
Chen S; Graff J; Yun S; Beal B; Ta JT; Bansal A; Carlson JJ; Veenstra DL; Basu A; Devine B
J Manag Care Spec Pharm; 2021 Jan; 27(1):95-104. PubMed ID: 33377442
[TBL] [Abstract][Full Text] [Related]
12. Real-world evidence for regulatory decision-making: updated guidance from around the world.
Burns L; Le Roux N; Kalesnik-Orszulak R; Christian J; Dudinak J; Rockhold F; Khozin S; O'Donnell J
Front Med (Lausanne); 2023; 10():1236462. PubMed ID: 38020096
[TBL] [Abstract][Full Text] [Related]
13. [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]
14. Is Real-World Evidence Used in P&T Monographs and Therapeutic Class Reviews?
Hurwitz JT; Brown M; Graff JS; Peters L; Malone DC
J Manag Care Spec Pharm; 2020 Dec; 26(12):1604-1611. PubMed ID: 33251991
[TBL] [Abstract][Full Text] [Related]
15. Hybrid clinical trials to generate real-world evidence: design considerations from a sponsor's perspective.
Zhu M; Sridhar S; Hollingsworth R; Chit A; Kimball T; Murmello K; Greenberg M; Gurunathan S; Chen J
Contemp Clin Trials; 2020 Jul; 94():105856. PubMed ID: 31669449
[TBL] [Abstract][Full Text] [Related]
16. Use of Real-World Evidence in Neuroscience-Related New Drug and Biologics License Applications for Novel Therapeutics.
Bloomfield-Clagett B; Rahman M; Smith K; Concato J
Clin Pharmacol Ther; 2023 Nov; 114(5):1002-1005. PubMed ID: 37548904
[TBL] [Abstract][Full Text] [Related]
17. Improving Transparency to Build Trust in Real-World Secondary Data Studies for Hypothesis Testing-Why, What, and How: Recommendations and a Road Map from the Real-World Evidence Transparency Initiative.
Orsini LS; Berger M; Crown W; Daniel G; Eichler HG; Goettsch W; Graff J; Guerino J; Jonsson P; Lederer NM; Monz B; Mullins CD; Schneeweiss S; Brunt DV; Wang SV; Willke RJ
Value Health; 2020 Sep; 23(9):1128-1136. PubMed ID: 32940229
[TBL] [Abstract][Full Text] [Related]
18. Real-World Evidence: A Primer.
Dang A
Pharmaceut Med; 2023 Jan; 37(1):25-36. PubMed ID: 36604368
[TBL] [Abstract][Full Text] [Related]
19. Use of real-world evidence for oncology clinical decision making in emerging economies.
Petracci F; Ghai C; Pangilinan A; Suarez LA; Uehara R; Ghosn M
Future Oncol; 2021 Aug; 17(22):2951-2960. PubMed ID: 34044583
[TBL] [Abstract][Full Text] [Related]
20. Contribution of Real-World Evidence in European Medicines Agency's Regulatory Decision Making.
Bakker E; Plueschke K; Jonker CJ; Kurz X; Starokozhko V; Mol PGM
Clin Pharmacol Ther; 2023 Jan; 113(1):135-151. PubMed ID: 36254408
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]