Good Clinical Trials by removing defensive interpretation of Good Clinical Practice guidelines

被引:4
|
作者
den Heijer, Jonas M. [1 ,2 ]
Heuberger, Jules A. A. C. [1 ,2 ]
Hijma, Hemme [1 ,2 ]
Kruithof, Annelieke C. [1 ,2 ]
van Smeden, Jeroen [1 ,2 ]
Groeneveld, Geert Jan [1 ,2 ]
Burggraaf, Jacobus [1 ,2 ]
Cohen, Adam [1 ,2 ]
机构
[1] Ctr Human Drug Res, Clin Pharmacol, Leiden, Netherlands
[2] Leiden Univ, Med Ctr, Clin Pharmacol, Leiden, Netherlands
关键词
bureaucracy; clinical trials; drug development; regulation; INNOVATION; IMPACT; COST;
D O I
10.1111/bcp.14843
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
引用
收藏
页码:4552 / 4559
页数:8
相关论文
共 50 条
  • [1] MRC guidelines for good clinical practice in clinical trials
    Vere, D
    [J]. JOURNAL OF MEDICAL ETHICS, 1999, 25 (03) : 280 - 281
  • [2] Good Publication Practice guidelines for clinical trials?
    Alfaro, V
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2003, 74 (01) : 97 - 98
  • [3] Is good clinical research practice for clinical trials good clinical practice?
    Yastrubetskaya, O
    Chiu, E
    OConnell, S
    [J]. INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, 1997, 12 (02) : 227 - 231
  • [4] Clinical Trials and Good Clinical Practice
    Suzuki-Nishimura, Tamiko
    [J]. JOURNAL OF HEALTH SCIENCE, 2010, 56 (03) : 231 - 238
  • [5] Good Clinical Practice Guidelines and ISO 9001:2015: Their association with clinical trials
    Alvarez Guerra, S.
    Rodriguez Alvarez, J.
    Rodriguez Bernabe, A.
    [J]. JOURNAL OF HEALTHCARE QUALITY RESEARCH, 2020, 35 (01) : 52 - 53
  • [6] Implementation of good clinical practice guidelines in vaccine trials in developing countries
    Acosta, Camilo J.
    Galindo, Claudia M.
    Ochiai, R. Leon
    Danovaro-Holliday, M. Carolina
    Laure-Page, Anne
    Thiem, Vu Dinh
    Jin, Yang
    Khan, Mohammad Imran
    Sahito, Shah Muhammad
    Bin Hamza, Hasan
    Park, Jin Kyoung
    Lee, Hyejon
    Bock, Hans
    Abu Elyazeed, Remon
    Albert, M. John
    Ascaso, Carlos
    Robles, Tonette Q.
    Ali, Mohammad
    Ngai, Philip
    Puri, Mahesh K.
    Koo, Young Mo
    Agtini, Magdarina D.
    Soeharno, Rooswanti
    Dong Bai-qing
    Kohl, Daniele
    Xu, Zhi-Yi
    Ivanoff, Bernard
    Jodara, Luis
    Pang, Tikki
    Bhutta, Zultiqar
    Clemens, John D.
    [J]. VACCINE, 2007, 25 (15) : 2852 - 2857
  • [7] Clinical trials: Towards good practice
    Ablett, S
    [J]. ARCHIVES OF DISEASE IN CHILDHOOD, 1997, 76 (03) : 283 - 285
  • [8] Clinical guidelines as a tool for ensuring good clinical practice
    Zimlichman, E
    Meilik-Weiss, A
    [J]. ISRAEL MEDICAL ASSOCIATION JOURNAL, 2004, 6 (10): : 626 - 627
  • [9] Good clinical practice in clinical trials: training of clinicians, incitation to apply good clinical practice and assessment of compliance
    Belorgey, C
    Demarez, JP
    Jaillon, P
    [J]. THERAPIE, 2002, 57 (04): : 339 - 346
  • [10] Clinical practice guidelines: The good, the bad, and the Ugly
    Guerra-Farfan, Ernesto
    Garcia-Sanchez, Yaiza
    Jornet-Gibert, Montsant
    Nunez, Jorge H.
    Balaguer-Castro, Mariano
    Madden, Kim
    [J]. INJURY-INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, 2023, 54 : S26 - S29