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Volumn 99, Issue 1, 2016, Pages 82-91

Emerging innovations in clinical trial design

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BREAST CANCER; CANCER RESEARCH; CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DOSE CALCULATION; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; ONCOLOGY; PRIORITY JOURNAL; METHODOLOGY; PROCEDURES;

EID: 84955270265     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.285     Document Type: Article
Times cited : (39)

References (44)
  • 1
    • 84955298426 scopus 로고    scopus 로고
    • Part A. Boundaries Between Practice and Research (18 April 1979) Federal Register Lt;>. Accessed 16 August
    • Office of the Secretary, United States Department of Health, Education and Welfare, (18 April 1979) Federal Register 44 (76): 23191-7. Part A. Boundaries Between Practice and Research. < http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html >. Accessed 16 August 2015.
    • (2015) Office of the Secretary, United States Department of Health, Education and Welfare , vol.44 , Issue.76 , pp. 23191-23197
  • 2
    • 84955257977 scopus 로고    scopus 로고
    • Oncology Times. 35, 11-12 (2013). DOI: 10.1097/01.COT.0000432325.77902.74.
    • (2013) Oncology Times , vol.35 , pp. 11-12
  • 3
    • 84859438491 scopus 로고    scopus 로고
    • Adaptive clinical trials in oncology
    • Berry, D.A., Adaptive clinical trials in oncology. Nat. Rev. Clin. Oncol. 9, 199-207 (2012).
    • (2012) Nat. Rev. Clin. Oncol. , vol.9 , pp. 199-207
    • Berry, D.A.1
  • 4
    • 84928587092 scopus 로고    scopus 로고
    • The Brave New World of clinical cancer research: Adaptive biomarker-driven trials integrating clinical practice with clinical research
    • Berry, D.A., The Brave New World of clinical cancer research: adaptive biomarker-driven trials integrating clinical practice with clinical research. Mol. Oncol. 9, 951-959 (2015).
    • (2015) Mol. Oncol. , vol.9 , pp. 951-959
    • Berry, D.A.1
  • 5
    • 0027220453 scopus 로고
    • A case for Bayesianism in clinical trials (with discussion)
    • Berry, D.A., A case for Bayesianism in clinical trials (with discussion). Statistics in Medicine 12, 1377-1404 (1993).
    • (1993) Statistics in Medicine , vol.12 , pp. 1377-1404
    • Berry, D.A.1
  • 6
    • 4043132499 scopus 로고    scopus 로고
    • Bayesian statistics and the efficiency and ethics of clinical trials
    • Berry, D.A., Bayesian statistics and the efficiency and ethics of clinical trials. Statistical Science 19, 175-187 (2004).
    • (2004) Statistical Science , vol.19 , pp. 175-187
    • Berry, D.A.1
  • 7
    • 33644861229 scopus 로고    scopus 로고
    • A guide to drug discovery: Bayesian clinical trials
    • Berry, D.A., A guide to drug discovery: Bayesian clinical trials. Nat. Rev. Drug Discov. 5, 27-36 (2006).
    • (2006) Nat. Rev. Drug Discov. , vol.5 , pp. 27-36
    • Berry, D.A.1
  • 9
    • 67649306739 scopus 로고    scopus 로고
    • Bayesian clinical trials at the University of Texas M. D. Anderson Cancer Center
    • Biswas, S., Liu, D.D., Lee, J.J., &, Berry, D.A., Bayesian clinical trials at the University of Texas M. D. Anderson Cancer Center. Clin. Trials 6, 205-216 (2009).
    • (2009) Clin. Trials , vol.6 , pp. 205-216
    • Biswas, S.1    Liu, D.D.2    Lee, J.J.3    Berry, D.A.4
  • 10
    • 0028887994 scopus 로고
    • Adaptive assignment versus balanced randomization in clinical trials: A decision analysis
    • Berry, D.A., &, Eick, S.G., Adaptive assignment versus balanced randomization in clinical trials: a decision analysis. Stat. Med. 14, 231-246 (1995).
    • (1995) Stat. Med. , vol.14 , pp. 231-246
    • Berry, D.A.1    Eick, S.G.2
  • 11
    • 84955300689 scopus 로고    scopus 로고
    • Accessed 16 August
    • < https://clinicaltrials.gov/ct2/show/NCT02465060 >. Accessed 16 August 2015.
    • (2015)
  • 12
    • 84955242151 scopus 로고    scopus 로고
    • Accessed 16 August
    • < http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match >. Accessed 16 August 2015.
    • (2015)
  • 13
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • Simon, R., Optimal two-stage designs for phase II clinical trials. Control. Clin. Trials 10, 1-10 (1989).
    • (1989) Control. Clin. Trials , vol.10 , pp. 1-10
    • Simon, R.1
  • 14
    • 84863230465 scopus 로고    scopus 로고
    • Unresponsiveness of colon cancer to BRAF(V600E) inhibition through feedback activation of EGFR
    • Prahallad, A., et al,. Unresponsiveness of colon cancer to BRAF(V600E) inhibition through feedback activation of EGFR. Nature 483, 100-103 (2012).
    • (2012) Nature , vol.483 , pp. 100-103
    • Prahallad, A.1
  • 15
    • 84955277544 scopus 로고    scopus 로고
    • ASCO Post 4. <>. Accessed 16 August 2015.
    • Helwick, C., BRAF mutations in colorectal cancer: the next frontier. ASCO Post 4. < http://www.ascopost.com/issues/april-15,-2013/braf-mutations-in-colorectal-cancer-the-next-frontier.aspx >. (2013). Accessed 16 August 2015.
    • (2013) BRAF Mutations in Colorectal Cancer: The Next Frontier
    • Helwick, C.1
  • 16
    • 84943364767 scopus 로고    scopus 로고
    • The Signature program: Bringing the protocol to the patient
    • Kang, B.P., et al,. The Signature program: bringing the protocol to the patient. Clin. Pharmacol. Ther. 98, 124-126 (2015).
    • (2015) Clin. Pharmacol. Ther. , vol.98 , pp. 124-126
    • Kang, B.P.1
  • 18
    • 0000129805 scopus 로고
    • Stein's paradox in statistics
    • Efron, B., &, Morris, C., Stein's paradox in statistics. Sci. Am. 5, 119-127 (1977).
    • (1977) Sci. Am. , vol.5 , pp. 119-127
    • Efron, B.1    Morris, C.2
  • 19
    • 0001486499 scopus 로고    scopus 로고
    • Estimation with quadratic loss
    • (University of California Press, Berkeley, CA)
    • James, W., &, Stein, C., Estimation with quadratic loss. Proc. Fourth Berkeley Symp. Math. Stat. Prob. Vol 1 361-379, (University of California Press, Berkeley, CA).
    • Proc. Fourth Berkeley Symp. Math. Stat. Prob. , vol.1 , pp. 361-379
    • James, W.1    Stein, C.2
  • 23
    • 84955268546 scopus 로고    scopus 로고
    • Accessed 16 August
    • < www.ispy2.org >. Accessed 16 August 2015.
    • (2015)
  • 24
    • 84955292455 scopus 로고    scopus 로고
    • Accessed 16 August
    • < https://clinicaltrials.gov/ct2/show/NCT01042379 >. Accessed 16 August 2015.
    • (2015)
  • 25
    • 67650652432 scopus 로고    scopus 로고
    • I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy
    • Barker, A.D., et al,. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin. Pharmacol. Ther. 86, 97-100 (2009).
    • (2009) Clin. Pharmacol. Ther. , vol.86 , pp. 97-100
    • Barker, A.D.1
  • 28
    • 84955251536 scopus 로고    scopus 로고
    • Accessed 16 August
    • AACR2014; < http://www.abstractsonline.com/Plan/ViewAbstract.aspx?mID=3404&sKey=ed5341ec-ef13-493e-8844-e14be322679c&cKey=d9b44ad7-1673-4ec9-b360-11254fbb92be&mKey=6ffe1446-a164-476a-92e7-c26446874d93 >. Accessed 16 August 2015.
    • (2015) AACR2014
  • 29
    • 84955244789 scopus 로고    scopus 로고
    • Accessed 16 August.
    • ASCO 2015. < http://meetinglibrary.asco.org/content/150770-156 >. Accessed 16 August 2015.
    • (2015) ASCO 2015
  • 30
    • 84955327843 scopus 로고    scopus 로고
    • Accessed 16 August
    • < http://www.imi.europa.eu >. Accessed 16 August 2015.
    • (2015)
  • 31
    • 84925285681 scopus 로고    scopus 로고
    • The Innovative Medicines Initiative: An engine for regulatory science
    • Goldman, M., Seigneuret, N., &, Eichler, H.-G., The Innovative Medicines Initiative: an engine for regulatory science. Nat. Rev. Drug Discov. 14, 1-2 (2015).
    • (2015) Nat. Rev. Drug Discov. , vol.14 , pp. 1-2
    • Goldman, M.1    Seigneuret, N.2    Eichler, H.-G.3
  • 32
    • 84864687000 scopus 로고    scopus 로고
    • Bayesian adaptive trial design in acute heart failure syndromes: Moving beyond the mega trial
    • Collins, S.P., et al,. Bayesian adaptive trial design in acute heart failure syndromes: moving beyond the mega trial. Am. Heart J. 164, 138-145.
    • Am. Heart J. , vol.164 , pp. 138-145
    • Collins, S.P.1
  • 33
    • 84955245805 scopus 로고    scopus 로고
    • (2012) Accessed 16 August
    • < http://www.PREPARE-Europe.eu/About-us/Partners >. (2012) Accessed 16 August 2015.
    • (2015)
  • 34
    • 0012838924 scopus 로고    scopus 로고
    • Adaptive Bayesian designs for dose-ranging drug trials
    • In (ed. Gatsonis, C. et al.) (Springer, New York)
    • Berry, D.A., et al,. Adaptive Bayesian designs for dose-ranging drug trials. In Case Studies in Bayesian Statistics V (ed., Gatsonis, C., et al.) 99-181 (Springer, New York, 2001).
    • (2001) Case Studies in Bayesian Statistics v , pp. 99-181
    • Berry, D.A.1
  • 35
    • 84882961810 scopus 로고    scopus 로고
    • Application of adaptive design methodology in development of a long-acting glucagon-like peptide-1 analog (dulaglutide): Statistical design and simulations
    • Skrivanek, Z., et al,. Application of adaptive design methodology in development of a long-acting glucagon-like peptide-1 analog (dulaglutide): statistical design and simulations. J. Diabetes Sci. Technol. 6, 1305-1318 (2012).
    • (2012) J. Diabetes Sci. Technol. , vol.6 , pp. 1305-1318
    • Skrivanek, Z.1
  • 36
    • 84882997236 scopus 로고    scopus 로고
    • An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): Trial design and baseline characteristics
    • Geiger, M.J., Skrivanek, Z., Gaydos, B., Chien, J., Berry, S., Berry, D., Anderson, J.H,. An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): trial design and baseline characteristics. J. Diabetes Sci. Technol. 6, 1319-1327 (2012).
    • (2012) J. Diabetes Sci. Technol. , vol.6 , pp. 1319-1327
    • Geiger, M.J.1    Skrivanek, Z.2    Gaydos, B.3    Chien, J.4    Berry, S.5    Berry, D.6    Anderson, J.H.7
  • 38
    • 84955301268 scopus 로고    scopus 로고
    • Accessed 16 August
    • < http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm415180.htm >. Accessed 16 August 2015.
    • (2015)
  • 39
    • 84955259001 scopus 로고    scopus 로고
    • Accessed 16 August
    • < http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment-report/human/002825/WC500179473.pdf >. Accessed 16 August 2015.
    • (2015)
  • 40
    • 84947400374 scopus 로고
    • Sequential medical trials
    • Anscombe, F.J., Sequential medical trials. J. Am. Stat. Assoc. 58, 365-383 (1963).
    • (1963) J. Am. Stat. Assoc. , vol.58 , pp. 365-383
    • Anscombe, F.J.1
  • 41
    • 0000909101 scopus 로고
    • A model for selecting one of two medical treatments
    • Colton, T., A model for selecting one of two medical treatments. J. Am. Stat. Assoc. 58, 388-400 (1963).
    • (1963) J. Am. Stat. Assoc. , vol.58 , pp. 388-400
    • Colton, T.1
  • 42
    • 3843053372 scopus 로고    scopus 로고
    • Choosing sample size for a clinical trial using decision analysis
    • Cheng, Y., Su, F., &, Berry, D.A., Choosing sample size for a clinical trial using decision analysis. Biometrika 90, 923-936 (2003).
    • (2003) Biometrika , vol.90 , pp. 923-936
    • Cheng, Y.1    Su, F.2    Berry, D.A.3
  • 43
    • 84902343266 scopus 로고
    • Modified two-armed bandit strategies for certain clinical trials
    • Berry, D.A., Modified two-armed bandit strategies for certain clinical trials. J. Am. Stat. Assoc. 73, 339-345 (1978).
    • (1978) J. Am. Stat. Assoc. , vol.73 , pp. 339-345
    • Berry, D.A.1
  • 44
    • 0000164521 scopus 로고
    • Bayesian multistage decision problems
    • Witmer, J.A., Bayesian multistage decision problems. Ann. Stat. 14, 283-297 (1986).
    • (1986) Ann. Stat. , vol.14 , pp. 283-297
    • Witmer, J.A.1


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