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 *

347 related articles for article (PubMed ID: 30862182)

  • 21. 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]  

  • 22. The history and contemporary challenges of the US Food and Drug Administration.
    Borchers AT; Hagie F; Keen CL; Gershwin ME
    Clin Ther; 2007 Jan; 29(1):1-16. PubMed ID: 17379043
    [TBL] [Abstract][Full Text] [Related]  

  • 23. 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]  

  • 24. 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]  

  • 25. 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]  

  • 26. Combination products regulation at the FDA.
    Lauritsen KJ; Nguyen T
    Clin Pharmacol Ther; 2009 May; 85(5):468-70. PubMed ID: 19381151
    [TBL] [Abstract][Full Text] [Related]  

  • 27. 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]  

  • 28. FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
    Darrow JJ; Avorn J; Kesselheim AS
    JAMA; 2020 Jan; 323(2):164-176. PubMed ID: 31935033
    [TBL] [Abstract][Full Text] [Related]  

  • 29. 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]  

  • 30. The Expanding Role of Real-World Evidence Trials in Health Care Decision Making.
    Klonoff DC
    J Diabetes Sci Technol; 2020 Jan; 14(1):174-179. PubMed ID: 30841738
    [TBL] [Abstract][Full Text] [Related]  

  • 31. 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]  

  • 32. Developing a framework to incorporate real-world evidence in cancer drug funding decisions: the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration.
    Chan K; Nam S; Evans B; de Oliveira C; Chambers A; Gavura S; Hoch J; Mercer RE; Dai WF; Beca J; Tadrous M; Isaranuwatchai W
    BMJ Open; 2020 Jan; 10(1):e032884. PubMed ID: 31915169
    [TBL] [Abstract][Full Text] [Related]  

  • 33. A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks.
    Gressler LE; Marinac-Dabic D; Resnic FS; Williams S; Yang K; Weichold F; Avila-Tang E; Mack C; Coplan P; Panagiotou OA; Pappas G
    Ther Innov Regul Sci; 2024 Nov; 58(6):1042-1052. PubMed ID: 39060838
    [TBL] [Abstract][Full Text] [Related]  

  • 34. 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]  

  • 35. Real-world Data and Evidence to support a switch in status from Prescription drug to Over the Counter drug as applied by the EMA, the US FDA, the MHRA, and the BfArM.
    Kühler TC; Ateka A; Lassoued Z; Routhier FX; Mékary-Sawaya S
    Clin Ther; 2024 Mar; 46(3):208-216. PubMed ID: 38278703
    [TBL] [Abstract][Full Text] [Related]  

  • 36. Developing a Canadian Real-World Evidence Action Plan across the Drug Life Cycle.
    Tadrous M; Ahuja T; Ghosh B; Kropp R
    Healthc Policy; 2020 May; 15(4):41-47. PubMed ID: 32538348
    [TBL] [Abstract][Full Text] [Related]  

  • 37. Real-world evidence to support regulatory submissions: A landscape review and assessment of use cases.
    Alipour-Haris G; Liu X; Acha V; Winterstein AG; Burcu M
    Clin Transl Sci; 2024 Aug; 17(8):e13903. PubMed ID: 39092896
    [TBL] [Abstract][Full Text] [Related]  

  • 38. Health Canada Usage of Real World Evidence (RWE) in Regulatory Decision Making compared with FDA/EMA usage based on publicly available information.
    Lau C; Jamali F; Loebenberg R
    J Pharm Pharm Sci; 2022; 25():227-236. PubMed ID: 35760071
    [TBL] [Abstract][Full Text] [Related]  

  • 39. 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]  

  • 40. FDA not NIH can speed new drugs.
    Miller HI
    Nature; 2011 Apr; 472(7342):169. PubMed ID: 21490657
    [No Abstract]   [Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 18.