Key Performance Indicators of Clinical Trials in JapanImplications for Reducing the Drug Lag

被引:0
|
作者
Michinori Terada
Mamoru Narukawa
Masahiro Takeuchi
机构
[1] Kitasato University,Department of Pharmaceutical Medicines, Graduate School of Pharmaceutical Sciences
[2] Clinical Research,Tokyo Laboratories
[3] Pfizer Global R&D,undefined
关键词
Azithromycin; Recruitment Rate; Project Assistant; Source Data Verification; Investigational Review Board;
D O I
10.1007/BF03256786
中图分类号
学科分类号
摘要
Background: In Japan, the launch of new drugs is often delayed compared with other major regions, including the US and European countries. This so-called ‘drug lag’ is a significant problem because patients are being denied access to new and potentially life-saving therapies.
引用
收藏
页码:305 / 308
页数:3
相关论文
共 50 条
  • [41] KEY PERFORMANCE INDICATORS: MONITORING AND EVALUATION
    Dumitrescu, Andreea
    Dumitriu, Dan
    MANAGEMENT - FACING NEW TECHNOLOGY CHALLENGES, ICMIE 2013, 2013, : 423 - 429
  • [42] Key Performance Indicators: Ideation to Creation
    Bishop D.A.
    IEEE Engineering Management Review, 2018, 46 (01): : 13 - 15
  • [43] KEY PERFORMANCE INDICATORS FOR THE CREATIVE INDUSTRY
    Vartiak, Lukas
    Garbarova, Miriam
    BALTIC JOURNAL OF ECONOMIC STUDIES, 2024, 10 (02) : 14 - 23
  • [44] Indicators of clinical performance
    McKee, M
    BRITISH MEDICAL JOURNAL, 1997, 315 (7101): : 142 - 142
  • [45] Reducing rater bias in clinical trials
    Kane, J. M.
    INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY, 2008, 11 : 64 - 64
  • [46] CLINICAL TRIALS FOR REDUCING CARDIOVASCULAR MORTALITY
    Galoiu, S.
    ACTA ENDOCRINOLOGICA-BUCHAREST, 2014, 10 (04) : 713 - 715
  • [47] Pediatric Clinical Drug Trials in Low-Income Countries: Key Ethical Issues
    MacLeod, S. M.
    Knoppert, D. C.
    Stanton-Jean, M.
    Avard, D.
    PEDIATRIC DRUGS, 2015, 17 (01) : 83 - 90
  • [48] Pediatric Clinical Drug Trials in Low-Income Countries: Key Ethical Issues
    S. M. MacLeod
    D. C. Knoppert
    M. Stanton-Jean
    D. Avard
    Pediatric Drugs, 2015, 17 : 83 - 90
  • [49] Central statistical monitoring in multicentre clinical trials: developing statistical approaches for analysing key risk indicators
    Elsa Valdes-Marquez
    Jemma C Hopewell
    Jane Armitage
    Martin Landray
    Trials, 14 (Suppl 1)
  • [50] Quality manufacturing key to reducing drug shortages
    Wechsler, Jill
    Pharmaceutical Technology, 2018, 42 (12) : 14 - 15