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Volumn 17, Issue 1, 2017, Pages

A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines

Author keywords

Adaptive; Adaptive design; Cancer; Clinical trials; Interim analysis; Review

Indexed keywords

HUMAN; METHODOLOGY; ONCOLOGY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS;

EID: 85024493564     PISSN: None     EISSN: 14712288     Source Type: Journal    
DOI: 10.1186/s12874-017-0393-6     Document Type: Article
Times cited : (33)

References (18)
  • 1
    • 44949171503 scopus 로고    scopus 로고
    • Adaptive design methods in clinical trials-a review
    • Chow S-C, Chang M. Adaptive design methods in clinical trials-a review. Orphanet J Rare Dis. 2008;3(11):169-90.
    • (2008) Orphanet J Rare Dis , vol.3 , Issue.11 , pp. 169-190
    • Chow, S.-C.1    Chang, M.2
  • 2
    • 84865271518 scopus 로고    scopus 로고
    • Adaptive trial designs: A review of barriers and opportunities
    • 22917111 3519822
    • Kairalla JA, et al. Adaptive trial designs: a review of barriers and opportunities. Trials. 2012;13(1):145.
    • (2012) Trials , vol.13 , Issue.1 , pp. 145
    • Kairalla, J.A.1
  • 3
    • 84977964939 scopus 로고    scopus 로고
    • Adaptive design clinical trials for drugs and biologics
    • Food US, Administration D. Adaptive design clinical trials for drugs and biologics. Biotechnol Law Rep. 2010;29(2):173.
    • (2010) Biotechnol Law Rep , vol.29 , Issue.2 , pp. 173
    • Food, U.S.1    Administration, D.2
  • 6
    • 33646257465 scopus 로고    scopus 로고
    • Application of adaptive designs-a review
    • 1:STN:280:DC%2BD28rkslGjug%3D%3D 16972701
    • Bauer P, Einfalt J. Application of adaptive designs-a review. Biom J. 2006;48(4):493-506.
    • (2006) Biom J , vol.48 , Issue.4 , pp. 493-506
    • Bauer, P.1    Einfalt, J.2
  • 7
    • 84951133315 scopus 로고    scopus 로고
    • An Investigation of the Shortcomings of the CONSORT 2010 Statement for the reporting of group sequential randomised controlled trials: A methodological systematic review
    • 26528812 4631356
    • Stevely A, et al. An Investigation of the Shortcomings of the CONSORT 2010 Statement for the reporting of group sequential randomised controlled trials: a methodological systematic review. PLoS One. 2015;10(11):e0141104.
    • (2015) PLoS One , vol.10 , Issue.11 , pp. e0141104
    • Stevely, A.1
  • 8
    • 84961201800 scopus 로고    scopus 로고
    • Adaptive designs undertaken in clinical research: A review of registered clinical trials
    • Hatfield I, et al. Adaptive designs undertaken in clinical research: a review of registered clinical trials. Trials. 2016;17(1):1.
    • (2016) Trials , vol.17 , Issue.1 , pp. 1
    • Hatfield, I.1
  • 9
    • 65649093620 scopus 로고    scopus 로고
    • Adaptive designs for confirmatory clinical trials
    • 19206095
    • Bretz F, et al. Adaptive designs for confirmatory clinical trials. Stat Med. 2009;28(8):1181-217.
    • (2009) Stat Med , vol.28 , Issue.8 , pp. 1181-1217
    • Bretz, F.1
  • 10
    • 33846243782 scopus 로고    scopus 로고
    • A 25-year review of sequential methodology in clinical studies
    • 17139691
    • Todd S. A 25-year review of sequential methodology in clinical studies. Stat Med. 2007;26(2):237-52.
    • (2007) Stat Med , vol.26 , Issue.2 , pp. 237-252
    • Todd, S.1
  • 11
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • 497341
    • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35(3):549-56.
    • (1979) Biometrics , vol.35 , Issue.3 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 12
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • 1:STN:280:DyaL1M7ps1SjsQ%3D%3D 2702835
    • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10(1):1-10.
    • (1989) Control Clin Trials , vol.10 , Issue.1 , pp. 1-10
    • Simon, R.1
  • 13
    • 0043172579 scopus 로고    scopus 로고
    • Novel designs for multi-arm clinical trials with survival outcomes with an application in ovarian cancer
    • 12854091
    • Royston P, Parmar MK, Qian W. Novel designs for multi-arm clinical trials with survival outcomes with an application in ovarian cancer. Stat Med. 2003;22(14):2239-56.
    • (2003) Stat Med , vol.22 , Issue.14 , pp. 2239-2256
    • Royston, P.1    Parmar, M.K.2    Qian, W.3
  • 14
    • 85024483020 scopus 로고    scopus 로고
    • Medical Research Council Clinical Trials Unit Accessed 23 Feb 2017
    • Medical Research Council Clinical Trials Unit. MAMS Design. Available from: http://www.ctu.mrc.ac.uk/our-research/research-types/methodology1/design/mams-design/. Accessed 23 Feb 2017.
    • MAMS Design
  • 15
    • 79960536655 scopus 로고    scopus 로고
    • CONSORT Accessed 10 Apr 2017
    • CONSORT. Consolidated Standards of Reporting Trials. 2010. Available from: http://www.consort-statement.org/. Accessed 10 Apr 2017.
    • (2010) Consolidated Standards of Reporting Trials
  • 16
    • 42549099895 scopus 로고    scopus 로고
    • CONSORT for reporting randomised trials in journal and conference abstracts
    • 18221781
    • Hopewell S, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008;371(9609):281-3.
    • (2008) Lancet , vol.371 , Issue.9609 , pp. 281-283
    • Hopewell, S.1
  • 17
    • 38849186559 scopus 로고    scopus 로고
    • CONSORT for reporting randomized controlled trials in journal and conference abstracts: Explanation and elaboration
    • 18215107 2211558
    • Hopewell S, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008;5(1):e20.
    • (2008) PLoS Med , vol.5 , Issue.1 , pp. e20
    • Hopewell, S.1
  • 18
    • 8744229000 scopus 로고    scopus 로고
    • Better reporting of harms in randomized trials: An extension of the CONSORT statement
    • 15545678
    • Ioannidis JP, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141(10):781-8.
    • (2004) Ann Intern Med , vol.141 , Issue.10 , pp. 781-788
    • Ioannidis, J.P.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.