BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

198 related articles for article (PubMed ID: 38629484)

  • 1. Expert survey on real-world data utilization and real-world evidence generation for regulatory decision-making in drug lifecycle in Korea.
    Lee H; Ahn HS; Kwon S; Kang HY; Han E
    Clin Transl Sci; 2024 Apr; 17(4):e13801. PubMed ID: 38629484
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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]  

  • 3. Real-world evidence: perspectives on challenges, value, and alignment of regulatory and national health technology assessment data collection requirements.
    Sievers H; Joos A; Hiligsmann M
    Int J Technol Assess Health Care; 2021 Feb; 37():e40. PubMed ID: 33622423
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan.
    Nishioka K; Makimura T; Ishiguro A; Nonaka T; Yamaguchi M; Uyama Y
    Clin Pharmacol Ther; 2022 Jan; 111(1):35-43. PubMed ID: 34528701
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Real-world data: a comprehensive literature review on the barriers, challenges, and opportunities associated with their inclusion in the health technology assessment process.
    Zisis K; Pavi E; Geitona M; Athanasakis K
    J Pharm Pharm Sci; 2024; 27():12302. PubMed ID: 38481726
    [No Abstract]   [Full Text] [Related]  

  • 6. 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]  

  • 7. 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]  

  • 8. Data Governance for Real-World Data Management: A Proposal for a Checklist to Support Decision Making.
    Solà-Morales O; Sigurðardóttir K; Akehurst R; Murphy LA; Mestre-Ferrandiz J; Cunningham D; de Pouvourville G
    Value Health; 2023 Apr; 26(4S):32-42. PubMed ID: 36870678
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Maximizing the Value of Real-World Data and Real-World Evidence to Accelerate Healthcare Transformation in China: Summary of External Advisory Committee Meetings.
    Sun F; Bedenkov A; Liu BC; Yang J; Xu JF; Ji L; Zhou M; Zhang S; Li X; Song Y; Chen P; Moreno C
    Pharmaceut Med; 2024 May; 38(3):157-166. PubMed ID: 38573457
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

  • 11. 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]  

  • 12. 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]  

  • 13. 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]  

  • 14. 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]  

  • 15. 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]  

  • 16. [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]  

  • 17. What, Where, and How to Collect Real-World Data and Generate Real-World Evidence to Support Drug Reimbursement Decision-Making in Asia: A reflection Into the Past and A Way Forward.
    Kc S; Lin LW; Bayani DBS; Zemlyanska Y; Adler A; Ahn J; Chan K; Choiphel D; Genuino-Marfori AJ; Kearney B; Liu Y; Nakamura R; Pearce F; Prinja S; Pwu RF; Akmal Shafie A; Sui B; Suwantika A; Tunis S; Wu HM; Zalcberg J; Zhao K; Isaranuwatchai W; Teerawattananon Y; Wee HL
    Int J Health Policy Manag; 2023; 12():6858. PubMed ID: 37579427
    [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. 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]  

  • 20. 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]  

    [Next]    [New Search]
    of 10.