These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

167 related articles for article (PubMed ID: 32514737)

  • 1. Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review.
    Seifu Y; Gamalo-Siebers M; Barthel FM; Lin J; Qiu J; Cooner F; Ruan S; Walley R
    Ther Innov Regul Sci; 2020 Nov; 54(6):1436-1443. PubMed ID: 32514737
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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]  

  • 3. 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]  

  • 4. 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]  

  • 5. 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]  

  • 6. 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]  

  • 7. 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]  

  • 8. The use of real-world evidence to support FDA post-approval study requirements for oncology drugs.
    Zettler ME
    Expert Rev Anticancer Ther; 2022 Jun; 22(6):657-666. PubMed ID: 35512688
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe.
    Davenport C; Gravel P; Wang Y; Williams SA; Wieland A; Mitlak B
    Ther Innov Regul Sci; 2024 May; 58(3):505-518. PubMed ID: 38341388
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

  • 11. Statistical Considerations on the Use of RWD/RWE for Oncology Drug Approvals: Overview and Lessons Learned.
    Ro SK; Zhang W; Jiang Q; Li XN; Liu R; Lu CC; Marchenko O; Sun L; Zhao J
    Ther Innov Regul Sci; 2023 Jul; 57(4):899-910. PubMed ID: 37179264
    [TBL] [Abstract][Full Text] [Related]  

  • 12. 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]  

  • 13. 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]  

  • 14. Clinical Pharmacology Applications of Real-World Data and Real-World Evidence in Drug Development and Approval-An Industry Perspective.
    Zhu R; Vora B; Menon S; Younis I; Dwivedi G; Meng Z; Datta-Mannan A; Manchandani P; Nayak S; Tammara BK; Garhyan P; Iqbal S; Dagenais S; Chanu P; Mukherjee A; Ghobadi C;
    Clin Pharmacol Ther; 2023 Oct; 114(4):751-767. PubMed ID: 37393555
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Real-World Evidence, Public Participation, and the FDA.
    Schwartz JL
    Hastings Cent Rep; 2017 Nov; 47(6):7-8. PubMed ID: 29171057
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Demonstrating that Real World Evidence Is Fit-For-Purpose to Support Labeling: Parallels to Patient Reported Outcomes in the Pursuit of Labeling Claims.
    Girman CJ; Ritchey ME; McNeill AM; Sundell KA; Meyer RJ
    Ther Innov Regul Sci; 2021 May; 55(3):561-567. PubMed ID: 33507517
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Practical considerations of utilizing propensity score methods in clinical development using real-world and historical data.
    Li Q; Lin J; Chi A; Davies S
    Contemp Clin Trials; 2020 Oct; 97():106123. PubMed ID: 32853779
    [TBL] [Abstract][Full Text] [Related]  

  • 18. 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]  

  • 19. 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]  

  • 20. A Statistical Roadmap for Journey from Real-World Data to Real-World Evidence.
    Fang Y; Wang H; He W
    Ther Innov Regul Sci; 2020 Jul; 54(4):749-757. PubMed ID: 32557297
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.