BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

258 related articles for article (PubMed ID: 32071183)

  • 1. Patient burden and clinical advances associated with postapproval monotherapy cancer drug trials: a retrospective cohort study.
    Carlisle BG; Doussau A; Kimmelman J
    BMJ Open; 2020 Feb; 10(2):e034306. PubMed ID: 32071183
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Benefit, burden, and impact for a cohort of post-approval cancer combination trials.
    Carlisle BG; Doussau A; Kimmelman J
    Clin Trials; 2020 Feb; 17(1):18-29. PubMed ID: 31580145
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Diminishing clinical impact for post-approval cancer clinical trials: A retrospective cohort study.
    Ouimet C; Bouche G; Kimmelman J
    PLoS One; 2022; 17(9):e0274115. PubMed ID: 36094914
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study.
    Gyawali B; Rome BN; Kesselheim AS
    BMJ; 2021 Sep; 374():n1959. PubMed ID: 34497044
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments.
    Skydel JJ; Luxkaranayagam AT; Dhruva SS; Ross JS; Wallach JD
    JAMA Netw Open; 2019 May; 2(5):e193410. PubMed ID: 31074812
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration.
    Hutchinson N; Carlisle B; Doussau A; Bosan R; Gumnit E; MacPherson A; Fergusson DA; Kimmelman J
    JAMA Netw Open; 2021 May; 4(5):e2110456. PubMed ID: 34003270
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review.
    Pease AM; Krumholz HM; Downing NS; Aminawung JA; Shah ND; Ross JS
    BMJ; 2017 May; 357():j1680. PubMed ID: 28468750
    [No Abstract]   [Full Text] [Related]  

  • 8. Large numbers of patients are needed to obtain additional approvals for new cancer drugs: A retrospective cohort study.
    Ouimet C; Hutchinson N; Wang C; Matyka C; Del Paggio JC; Kimmelman J
    Sci Rep; 2023 Sep; 13(1):16138. PubMed ID: 37752147
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis.
    Naci H; Zhang Y; Woloshin S; Guan X; Xu Z; Wagner AK
    Lancet Oncol; 2024 Jun; 25(6):760-769. PubMed ID: 38754451
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.
    Ladanie A; Schmitt AM; Speich B; Naudet F; Agarwal A; Pereira TV; Sclafani F; Herbrand AK; Briel M; Martin-Liberal J; Schmid T; Ewald H; Ioannidis JPA; Bucher HC; Kasenda B; Hemkens LG
    JAMA Netw Open; 2020 Nov; 3(11):e2024406. PubMed ID: 33170262
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study.
    Wagner J; Marquart J; Ruby J; Lammers A; Mailankody S; Kaestner V; Prasad V
    BMJ; 2018 Mar; 360():k668. PubMed ID: 29514787
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Postmarketing Modifications of Drug Labels for Cancer Drugs Approved by the US Food and Drug Administration Between 2006 and 2016 With and Without Supporting Randomized Controlled Trials.
    Shepshelovich D; Tibau A; Goldvaser H; Molto C; Ocana A; Seruga B; Amir E
    J Clin Oncol; 2018 Jun; 36(18):1798-1804. PubMed ID: 29641296
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.
    Naci H; Smalley KR; Kesselheim AS
    JAMA; 2017 Aug; 318(7):626-636. PubMed ID: 28810023
    [TBL] [Abstract][Full Text] [Related]  

  • 14. US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018.
    Omae K; Onishi A; Sahker E; Furukawa TA
    JAMA Netw Open; 2022 Sep; 5(9):e2230973. PubMed ID: 36083581
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved.
    Zhang SX; Fergusson D; Kimmelman J
    J Natl Cancer Inst; 2020 Sep; 112(9):886-892. PubMed ID: 32239146
    [TBL] [Abstract][Full Text] [Related]  

  • 16. National Comprehensive Cancer Network Guideline Recommendations of Cancer Drugs With Accelerated Approval.
    Cliff ERS; Rome RS; Kesselheim AS; Rome BN
    JAMA Netw Open; 2023 Nov; 6(11):e2343285. PubMed ID: 37962889
    [TBL] [Abstract][Full Text] [Related]  

  • 17. An estimate of rate of deviation from NCCN guideline recommendations for central nervous system imaging in trials forming basis for drug approval in first line advanced non-small cell lung cancer (NSCLC).
    Sharp J; Prasad V
    BMC Cancer; 2022 Jan; 22(1):70. PubMed ID: 35034621
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study.
    Mooghali M; Mitchell AP; Skydel JJ; Ross JS; Wallach JD; Ramachandran R
    BMJ Med; 2024; 3(1):e000802. PubMed ID: 38596814
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Overall Survival, Progression-Free Survival, and Tumor Response Benefit Supporting Initial US Food and Drug Administration Approval and Indication Extension of New Cancer Drugs, 2003-2021.
    Michaeli DT; Michaeli T
    J Clin Oncol; 2022 Dec; 40(35):4095-4106. PubMed ID: 35921606
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Cancer Drug Approvals That Displaced Existing Standard-of-Care Therapies, 2016-2021.
    Benjamin DJ; Xu A; Lythgoe MP; Prasad V
    JAMA Netw Open; 2022 Mar; 5(3):e222265. PubMed ID: 35289858
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 13.