350 related articles for article (PubMed ID: 31562770)
1. Examining the Use of Real-World Evidence in the Regulatory Process.
Beaulieu-Jones BK; Finlayson SG; Yuan W; Altman RB; Kohane IS; Prasad V; Yu KH
Clin Pharmacol Ther; 2020 Apr; 107(4):843-852. PubMed ID: 31562770
[TBL] [Abstract][Full Text] [Related]
2. Nonrandomized Real-World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project.
Franklin JM; Pawar A; Martin D; Glynn RJ; Levenson M; Temple R; Schneeweiss S
Clin Pharmacol Ther; 2020 Apr; 107(4):817-826. PubMed ID: 31541454
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics.
Klonoff DC
J Diabetes Sci Technol; 2020 Mar; 14(2):345-349. PubMed ID: 30862182
[TBL] [Abstract][Full Text] [Related]
5. The use of real-world data/evidence in regulatory submissions.
Song F; Zang C; Ma X; Hu S; Sun Q; Chow SC; Sun H
Contemp Clin Trials; 2021 Oct; 109():106521. PubMed ID: 34339865
[TBL] [Abstract][Full Text] [Related]
6. ISPOR, the FDA, and the Evolving Regulatory Science of Medical Device Products.
O'Neill T; Miksad R; Miller D; Maloney L; John A; Hiller C; Hornberger J
Value Health; 2019 Jul; 22(7):754-761. PubMed ID: 31277820
[TBL] [Abstract][Full Text] [Related]
7. The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications.
Purpura CA; Garry EM; Honig N; Case A; Rassen JA
Clin Pharmacol Ther; 2022 Jan; 111(1):135-144. PubMed ID: 34726771
[TBL] [Abstract][Full Text] [Related]
8. Real-World Evidence in the Real World: Beyond the FDA.
Krause JH; Saver RS
Am J Law Med; 2018 May; 44(2-3):161-179. PubMed ID: 30106647
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. 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]
11. EA3: A softmax algorithm for evidence appraisal aggregation.
De Pretis F; Landes J
PLoS One; 2021; 16(6):e0253057. PubMed ID: 34138908
[TBL] [Abstract][Full Text] [Related]
12. 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]
13. 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]
14. Evaluating the Use of Nonrandomized Real-World Data Analyses for Regulatory Decision Making.
Franklin JM; Glynn RJ; Martin D; Schneeweiss S
Clin Pharmacol Ther; 2019 Apr; 105(4):867-877. PubMed ID: 30636285
[TBL] [Abstract][Full Text] [Related]
15. Use of Real-World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018-2019.
Eskola SM; Leufkens HGM; Bate A; De Bruin ML; Gardarsdottir H
Clin Pharmacol Ther; 2022 Jan; 111(1):310-320. PubMed ID: 34689334
[TBL] [Abstract][Full Text] [Related]
16. Use of Real-World Evidence to Support FDA Approval of Oncology Drugs.
Feinberg BA; Gajra A; Zettler ME; Phillips TD; Phillips EG; Kish JK
Value Health; 2020 Oct; 23(10):1358-1365. PubMed ID: 33032780
[TBL] [Abstract][Full Text] [Related]
17. Translational hurdles with cannabis medicines.
Graham M; Lucas CJ; Schneider J; Martin JH; Hall W
Pharmacoepidemiol Drug Saf; 2020 Oct; 29(10):1325-1330. PubMed ID: 32281186
[TBL] [Abstract][Full Text] [Related]
18. Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design.
Dagenais S; Russo L; Madsen A; Webster J; Becnel L
Clin Pharmacol Ther; 2022 Jan; 111(1):77-89. PubMed ID: 34839524
[TBL] [Abstract][Full Text] [Related]
19. Use of Real-World Evidence in US Payer Coverage Decision-Making for Next-Generation Sequencing-Based Tests: Challenges, Opportunities, and Potential Solutions.
Deverka PA; Douglas MP; Phillips KA
Value Health; 2020 May; 23(5):540-550. PubMed ID: 32389218
[TBL] [Abstract][Full Text] [Related]
20. Randomized Clinical Trial or Real-World Evidence: How Historical Events, Public Demand, and the Resulting Laws and Regulations Shaped the Body of Medical Evidence.
Mackowiak JI; Mack CD; Irwin DE; Zura R
J Orthop Trauma; 2021 Mar; 35(Suppl 1):S17-S21. PubMed ID: 33587542
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
