Testing dilemmas in the clinic: Lessons learned from biomarker-based drug development

被引：0
|
作者：
van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh [1 ,2 ]
Van Criekingen, Olga Kholmanskikh [3 ]
Koole, Simone [4 ]
Thomas, David M. [5 ]
Gelderblom, Hans [1 ]
机构：
[1] Leiden Univ, Med Ctr, Dept Med Oncol, Leiden, Netherlands
[2] CZ Hlth Insurance, Med Dept, Tilburg, Netherlands
[3] Belgian Fed Agcy Med & Hlth Prod FAMHP, Brussels, Belgium
[4] Zilveren Kruis, Med Advisory Dept, Zeist, Netherlands
[5] Univ New South Wales, Ctr Mol Oncol, Sydney, NSW, Australia
来源：
CANCER CELL | 2024年 / 42卷 / 06期
关键词：
HOMOLOGOUS RECOMBINATION DEFICIENCY;
D O I：
10.1016/j.ccell.2024.05.014
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
Various tests based on different biomarkers have been developed to identify the best candidates for poly(ADP-ribose) polymerase (PARP)-inhibitor therapy. However, due to the absence of harmonization regarding these complex biomarkers, along with various cutoff points and unknown spatial and temporal variations, it is difficult to define the clinical utility of each test and ensure uniformity in treatment decision-making. Here, we propose measures to align biomarker definitions and minimum analytical performance characteristics for diagnostics to ensure equitable and sustainable access to precision medicine.
引用
收藏
页码：923 / 929
页数：7
相关论文
共 50 条
  • [41] Lessons learned from development of docetaxel
    Strother, Robert Matthew
    Sweeney, Christopher
    EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY, 2008, 4 (07) : 1007 - 1019
  • [42] Lessons learned from candidate drug attrition
    Empfield, James R.
    Leeson, Paul D.
    IDRUGS, 2010, 13 (12) : 869 - 873
  • [43] From wearable sensor data to digital biomarker development: ten lessons learned and a framework proposal
    Daniore, Paola
    Nittas, Vasileios
    Haag, Christina
    Bernard, Juergen
    Gonzenbach, Roman
    von Wyl, Viktor
    NPJ DIGITAL MEDICINE, 2024, 7 (01):
  • [44] Moral Expertise in the Clinic: Lessons Learned from Medicine and Science
    McClimans, Leah
    Slowther, Anne
    JOURNAL OF MEDICINE AND PHILOSOPHY, 2016, 41 (04): : 401 - 415
  • [45] Lessons learned from an adult multidisciplinary vascular anomalies clinic
    Scardamaglia, L.
    AUSTRALASIAN JOURNAL OF DERMATOLOGY, 2019, 60 : 7 - 7
  • [46] Lessons learned from setting up a multidisciplinary clinic for adrenoleukodystrophy
    Yau, Mabel
    Estrella, Lissette
    Cork, Ernalyn
    Diaz, George
    Raynes, Hillary
    Rapaport, Robert
    HORMONE RESEARCH IN PAEDIATRICS, 2020, 93 : 103 - 103
  • [47] Model-based Testing of Cryptographic Components Lessons Learned from Experience
    Botella, Julien
    Bouquet, Fabrice
    Capuron, Jean-Francois
    Lebeau, Franck
    Legeard, Bruno
    Schadle, Florence
    2013 IEEE SIXTH INTERNATIONAL CONFERENCE ON SOFTWARE TESTING, VERIFICATION AND VALIDATION (ICST 2013), 2013, : 192 - 201
  • [48] Lessons Learned from Making the Transition to Model-Based GUI Testing
    Ramler, Rudolf
    Klammer, Claus
    Wetzlmaier, Thomas
    PROCEEDINGS OF THE 10TH ACM SIGSOFT INTERNATIONAL WORKSHOP ON AUTOMATING TEST CASE DESIGN, SELECTION, AND EVALUATION (A-TEST '19), 2019, : 22 - 27
  • [49] Success, Failure, and Transparency in Biomarker-Based Drug Development A Case Study of Cholesteryl Ester Transfer Protein Inhibitors
    Hey, Spencer Phillips
    Franklin, Jessica M.
    Avorn, Jerry
    Kesselheim, Aaron S.
    CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES, 2017, 10 (06):
  • [50] Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing
    Elliott, Kevin C.
    Volz, David C.
    JOURNAL OF NANOPARTICLE RESEARCH, 2012, 14 (01)
12345