Role of Phase 0 trials in drug development

被引：3
|
作者：
Doroshow, James H. [1 ]
Kummar, Shivaani [2 ]
机构：
[1] NCI, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA
[2] NCI, Med Oncol Branch, Ctr Canc Res, NIH, Bethesda, MD 20892 USA
来源：
FUTURE MEDICINAL CHEMISTRY | 2009年 / 1卷 / 08期
关键词：
ADP-RIBOSE POLYMERASE; CLINICAL-TRIALS; POLY(ADP-RIBOSE) POLYMERASE; CHEMOPREVENTION; INHIBITOR; ABT-888; FDA;
D O I：
10.4155/FMC.09.117
中图分类号：
R914 [药物化学];
学科分类号：
100701 ;
摘要：
Phase 0 trials can provide proof of concept that an agent modulates its intended target without exposing patients to the drug-tolerability testing that precedes efficacy evaluation. Drugs that do not modulate their targets can be discarded, focusing development resources on the most clinically promising agents. However, wider uptake of Phase 0 trials may be hindered by ethical concerns over their lack of therapeutic intent, the substantial resources required to develop and validate target assays or skepticism that such trials save development time.
引用
下载
收藏
页码：1375 / 1380
页数：6
相关论文
共 50 条
  • [1] Phase 0 trials for anticancer drug development
    Nature Reviews Drug Discovery, 2009, 8 (6) : 442 - 442
  • [2] Phase 0 trials: a platform for drug development?
    不详
    LANCET, 2009, 374 (9685): : 176 - 176
  • [3] Phase 0 Clinical Trials: An Answer to Drug Development Stagnation?
    LoRusso, Patricia M.
    JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (16) : 2586 - 2588
  • [4] Compressing drug development timelines in oncology using phase '0' trials
    Kummar, Shivaani
    Kinders, Robert
    Rubinstein, Larry
    Parchment, Ralph E.
    Murgo, Anthony J.
    Collins, Jerry
    Pickeral, Oxana
    Low, Jennifer
    Steinberg, Seth M.
    Gutierrez, Martin
    Yang, Sherry
    Helman, Lee
    Wiltrout, Robert
    Tomaszewski, Joseph E.
    Doroshow, James H.
    NATURE REVIEWS CANCER, 2007, 7 (02) : 131 - 139
  • [5] Compressing drug development timelines in oncology using phase '0' trials
    Shivaani Kummar
    Robert Kinders
    Larry Rubinstein
    Ralph E. Parchment
    Anthony J. Murgo
    Jerry Collins
    Oxana Pickeral
    Jennifer Low
    Seth M. Steinberg
    Martin Gutierrez
    Sherry Yang
    Lee Helman
    Robert Wiltrout
    Joseph E. Tomaszewski
    James H. Doroshow
    Nature Reviews Cancer, 2007, 7 : 131 - 139
  • [6] Dose optimization in drug development: role of phase IV trials
    Joubert, PH
    OPTIMAL DOSE IDENTIFICATION: EXCERTA MEDICA, 2001, 1220 : 51 - 65
  • [7] The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials
    S Marchetti
    J H M Schellens
    British Journal of Cancer, 2007, 97 : 577 - 581
  • [8] Phase 0 clinical trials in oncology: a paradigm shift for early drug development?
    Chris H. Takimoto
    Cancer Chemotherapy and Pharmacology, 2009, 63 : 703 - 709
  • [9] The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials
    Marchetti, S.
    Schellens, J. H. M.
    BRITISH JOURNAL OF CANCER, 2007, 97 (05) : 577 - 581
  • [10] Phase 0 clinical trials in oncology: a paradigm shift for early drug development?
    Takimoto, Chris H.
    CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2009, 63 (04) : 703 - 709
12345