메뉴 건너뛰기




Volumn 47, Issue 4, 2013, Pages 495-502

Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials

Author keywords

adaptive trials; communication; data monitoring committees; membership; roles and responsibilities

Indexed keywords

ALGORITHM; ARTICLE; CLINICAL TRIAL (TOPIC); COMPENSATION; CONFIDENTIALITY; CONFLICT; DECISION MAKING; EXPECTATION; HUMAN; INFORMATION PROCESSING; INTERPERSONAL COMMUNICATION; KNOWLEDGE; MONITORING; NON PROFIT ORGANIZATION; PATIENT SAFETY; PLANNING; PRIORITY JOURNAL; PROFESSIONAL STANDARD; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPONSIBILITY; STUDY DESIGN; TRAINING; WORK EXPERIENCE; WORKSHOP;

EID: 84879519364     PISSN: 21684790     EISSN: 21649200     Source Type: Journal    
DOI: 10.1177/2168479013486996     Document Type: Article
Times cited : (12)

References (13)
  • 5
    • 84879510989 scopus 로고    scopus 로고
    • European Medicines AgencyJuly 27, 2005
    • European Medicines Agency. Guideline on data monitoring committees. 2006.July 27, 2005. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003635.pdf.
    • (2006) Guideline on data monitoring committees
  • 6
    • 78751608557 scopus 로고    scopus 로고
    • Adaptive design clinical trials and trial logistics models in CNS drug development
    • Wang SJ,Hung JHM,O'Neill R.Adaptive design clinical trials and trial logistics models in CNS drug development.Eur Neuropsychopharmacol. 2011;21:159-166.
    • (2011) Eur Neuropsychopharmacol , vol.21 , pp. 159-166
    • Wang, S.J.1    Hung, J.H.M.2    O'Neill, R.3
  • 7
    • 80052048316 scopus 로고    scopus 로고
    • How adaptive trial designs can increase efficiency in psychiatric drug development: a case study
    • Shen J,Preskorn S,Dragalin V, et al.How adaptive trial designs can increase efficiency in psychiatric drug development: a case study.Innov Clin Neurosci. 2011;8 (26): 26-34.
    • (2011) Innov Clin Neurosci , vol.8 , Issue.26 , pp. 26-34
    • Shen, J.1    Preskorn, S.2    Dragalin, V.3
  • 9
    • 84863475669 scopus 로고    scopus 로고
    • On the independence of data monitoring committee in adaptive design clinical trials
    • Chow SC,Corey R,Lin M.On the independence of data monitoring committee in adaptive design clinical trials.J Biopharm Stat. 2012;22 (4): 853-867.
    • (2012) J Biopharm Stat , vol.22 , Issue.4 , pp. 853-867
    • Chow, S.C.1    Corey, R.2    Lin, M.3
  • 10
    • 33750884934 scopus 로고    scopus 로고
    • Confidentiality and trial integrity issues for adaptive designs
    • Gallo P.Confidentiality and trial integrity issues for adaptive designs.Drug Inf J. 2006;40:445-450.
    • (2006) Drug Inf J , vol.40 , pp. 445-450
    • Gallo, P.1
  • 11
    • 68849108178 scopus 로고    scopus 로고
    • Premature release of data from clinical trials of ezetimibe
    • Califf RM,Harrington RA,Blazing MA.Premature release of data from clinical trials of ezetimibe.N Engl J Med. 2009;361 (7): 712-717.
    • (2009) N Engl J Med , vol.361 , Issue.7 , pp. 712-717
    • Califf, R.M.1    Harrington, R.A.2    Blazing, M.A.3
  • 13
    • 70350139975 scopus 로고    scopus 로고
    • Good practices for adaptive clinical trials in pharmaceutical product development
    • Gaydos B,Anderson K,Berry DA, et al.Good practices for adaptive clinical trials in pharmaceutical product development.Drug Inf J. 2009;43 (5): 539-565.
    • (2009) Drug Inf J , vol.43 , Issue.5 , pp. 539-565
    • Gaydos, B.1    Anderson, K.2    Berry, D.A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.