Quality assurance in clinical trials

被引:24
|
作者
Ottevanger, PB
Therasse, P
van de Velde, C
Bernier, J
van Krieken, H
Grol, R
De Mulder, P
机构
[1] Univ Nijmegen Hosp, Dept Internal Med, Div Med Oncol, NL-6500 HB Nijmegen, Netherlands
[2] Eortc Data Ctr, Brussels, Belgium
[3] Leiden Univ, Med Ctr, Dept Surg, Leiden, Netherlands
[4] San Giovanni Hosp, Cantonal Dept Radiat Oncol, Bellinzona, Switzerland
[5] Univ Nijmegen, Med Ctr, Dept Pathol, Nijmegen, Netherlands
[6] Univ Nijmegen, Med Ctr, Ctr Qual Care Res, Nijmegen, Netherlands
关键词
quality assurance; clinical trials; surgery; radiotherapy; chemotherapy; outcome research; COOPERATIVE-ONCOLOGY-GROUP; DOUBLE DATA-ENTRY; SURGICAL ADJUVANT BREAST; RADIATION-THERAPY; EORTC RADIOTHERAPY; RANDOMIZED-TRIAL; RECTAL-CANCER; PREOPERATIVE RADIOTHERAPY; EUROPEAN ORGANIZATION; OVARIAN-CANCER;
D O I
10.1016/S1040-8428(03)00028-3
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
From the literature that was initially searched by electronic databases using the keywords quality, quality control and quality assurance in combination with clinical trials, surgery, pathology, radiotherapy, chemotherapy and data management, a comprehensive review is given on what quality assurance means, the various methods used for quality assurance in different aspects of clinical trials and the impact of this quality assurance on outcome and every day practice. (C) 2003 Elsevier Science Ireland Ltd. All rights reserved.
引用
收藏
页码:213 / 235
页数:23
相关论文
共 50 条
  • [31] DOSIMETRY FINDINGS FROM CLINICAL RADIOTHERAPY TRIALS WITH RECOMMENDATIONS FOR QUALITY ASSURANCE
    SHALEK, RJ
    KENNEDY, P
    STOVALL, M
    CUNDIFF, JH
    GAGNON, WF
    GRANT, W
    HANSON, WF
    INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 1976, : 94 - 94
  • [32] Quality assurance of drugs used in clinical trials: proposal for adapting guidelines
    Newton, Paul N.
    Schellenberg, David
    Ashley, Elizabeth A.
    Ravinetto, Raffaella
    Green, Michael D.
    ter Kuile, Feiko O.
    Tabernero, Patricia
    White, Nicholas J.
    Guerin, Philippe J.
    BMJ-BRITISH MEDICAL JOURNAL, 2015, 350
  • [33] Medical Physics in Clinical Trials: Design, Quality Assurance, and NIH Programs
    Xiao, Ying
    Vikram, B.
    Shankar, L.
    Capala, J.
    Kandarpa, K.
    Benedict, S.
    Glide-Hurst, C.
    Xiao, Y.
    MEDICAL PHYSICS, 2022, 49 (06) : E471 - E472
  • [34] QUALITY ASSURANCE OF STEROID-RECEPTOR ANALYSES IN CLINICAL-TRIALS
    ECKMAN, JB
    WIEHLE, SA
    STEFFEN, MC
    WITTLIFF, JL
    CLINICAL CHEMISTRY, 1981, 27 (06) : 1078 - 1078
  • [35] The role of medical physicists in clinical trials: More than quality assurance
    Kron, Tomas
    JOURNAL OF MEDICAL PHYSICS, 2013, 38 (03) : 111 - 114
  • [36] Radiation therapy quality assurance in clinical trials - Global harmonisation group
    Melidis, Christos
    Bosch, Walter R.
    Izewska, Joanna
    Fidarova, Elena
    Zubizarreta, Eduardo
    Ishikura, Satoshi
    Followill, David
    Galvin, James
    Xiao, Ying
    Ebert, Martin A.
    Kron, Tomas
    Clark, Catharine H.
    Miles, Elizabeth A.
    Aird, Edwin G. A.
    Weber, Damien C.
    Ulin, Kenneth
    Verellen, Dirk
    Hurkmans, Coen W.
    RADIOTHERAPY AND ONCOLOGY, 2014, 111 (03) : 327 - 329
  • [37] An Automated Drug Concentration Screening and Quality Assurance Program for Clinical Trials
    Thaddeus H. Grasela
    Edward J. Antal
    Jill Fiedler-Kelly
    Darcy J. Foit
    Brenda Barth
    Dean W. Knuth
    Barbara J. Carel
    Steven R. Cox
    Drug information journal : DIJ / Drug Information Association, 1999, 33 (1): : 273 - 279
  • [38] SYMPOSIUM ON METHODOLOGY AND QUALITY ASSURANCE IN CANCER CLINICAL-TRIALS - INTRODUCTION
    ELLENBERG, SS
    SIMON, R
    WITTES, RE
    CANCER TREATMENT REPORTS, 1985, 69 (10): : 1039 - 1039
  • [39] Patient reported measures as quality assurance tools in CNS clinical trials
    Daniel, D. G.
    Friedmann, B.
    Butler, A.
    VALUE IN HEALTH, 2008, 11 (03) : A128 - A129
  • [40] An automated drug concentration screening and quality assurance program for clinical trials
    Grasela, TH
    Antal, EJ
    Fiedler-Kelly, J
    Foit, DJ
    Barth, B
    Knuth, DW
    Carels, BJ
    Cox, SR
    DRUG INFORMATION JOURNAL, 1999, 33 (01): : 273 - 279