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Volumn 68, Issue 5, 2012, Pages 543-551

The practical application of adaptive study design in early phase clinical trials: A retrospective analysis of time savings

Author keywords

Adaptive study design; Clinical trials; Early phase; Protocol; Protocol amendments; Time savings

Indexed keywords

ADAPTIVE STUDY DESIGN; ARTICLE; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RETROSPECTIVE STUDY; STUDY DESIGN; TIME; UNITED KINGDOM;

EID: 84864278404     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-011-1176-3     Document Type: Article
Times cited : (14)

References (9)
  • 1
    • 33646245937 scopus 로고    scopus 로고
    • Adaptive designs in clinical drug development - An executive summary of the PhRMA working group
    • Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J (2006) Adaptive designs in clinical drug development - an executive summary of the PhRMA working group. J Biopharm Stat 16:275-283. http://www.gemini-grp.com/ Bayes/PhRMA.pdf
    • (2006) J Biopharm Stat , vol.16 , pp. 275-283
    • Gallo, P.1    Chuang-Stein, C.2    Dragalin, V.3    Gaydos, B.4    Krams, M.5    Pinheiro, J.6
  • 3
    • 50549174560 scopus 로고
    • The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent
    • Gehan EA (1961) The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. J Chronic Dis 13:346-353
    • (1961) J Chronic Dis , vol.13 , pp. 346-353
    • Gehan, E.A.1
  • 8
    • 84864279439 scopus 로고    scopus 로고
    • Communication from the commission - Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial
    • European Commission
    • European Commission (2010) Communication from the commission - detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial. OJC 82:1-19
    • (2010) OJC , vol.82 , pp. 1-19


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.