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Volumn 37, Issue 6, 2007, Pages 1033-1057

Cancer Clinical Trials: Development and Implementation

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; CARBOPLATIN; CISPLATIN; CYTOSTATIC AGENT; DOXORUBICIN; HISTONE DEACETYLASE INHIBITOR; LIPOSOME; MITOPODOZIDE; PLACEBO; PYRIDOXINE;

EID: 35348844567     PISSN: 01955616     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cvsm.2007.06.007     Document Type: Review
Times cited : (30)

References (65)
  • 1
    • 32144458734 scopus 로고    scopus 로고
    • Clinical trials going to the dogs; canine program to study tumor treatment, biology
    • Mack G.S. Clinical trials going to the dogs; canine program to study tumor treatment, biology. J Natl Cancer Inst 98 3 (2006) 161-162
    • (2006) J Natl Cancer Inst , vol.98 , Issue.3 , pp. 161-162
    • Mack, G.S.1
  • 2
    • 27144503126 scopus 로고    scopus 로고
    • Cancer researchers usher in dog days of medicine
    • Mack G.S. Cancer researchers usher in dog days of medicine. Nat Med 11 10 (2005) 1018
    • (2005) Nat Med , vol.11 , Issue.10 , pp. 1018
    • Mack, G.S.1
  • 4
    • 33845257837 scopus 로고    scopus 로고
    • Cancer clues from pet dogs
    • Waters D.J., and Wildasin K. Cancer clues from pet dogs. Sci Am 295 6 (2006) 94-101
    • (2006) Sci Am , vol.295 , Issue.6 , pp. 94-101
    • Waters, D.J.1    Wildasin, K.2
  • 5
    • 33746879918 scopus 로고    scopus 로고
    • Drug development in oncology; classical cytotoxics and molecularly targeted agents
    • Kummar S., Gutierrez M., Doroshow J.H., et al. Drug development in oncology; classical cytotoxics and molecularly targeted agents. Br J Clin Pharmacol 62 1 (2006) 15-26
    • (2006) Br J Clin Pharmacol , vol.62 , Issue.1 , pp. 15-26
    • Kummar, S.1    Gutierrez, M.2    Doroshow, J.H.3
  • 6
    • 33947596504 scopus 로고    scopus 로고
    • Why is cancer drug discovery so difficult
    • Kamb A., Wee S., and Lengauer C. Why is cancer drug discovery so difficult. Nat Rev Drug Discov 6 2 (2007) 115-120
    • (2007) Nat Rev Drug Discov , vol.6 , Issue.2 , pp. 115-120
    • Kamb, A.1    Wee, S.2    Lengauer, C.3
  • 7
    • 14044261316 scopus 로고    scopus 로고
    • What's wrong with our cancer models?
    • Kamb A. What's wrong with our cancer models?. Nat Rev Drug Discov 4 2 (2005) 161-165
    • (2005) Nat Rev Drug Discov , vol.4 , Issue.2 , pp. 161-165
    • Kamb, A.1
  • 8
    • 8844239164 scopus 로고    scopus 로고
    • Stopping clinical trials by design
    • Whitehead J. Stopping clinical trials by design. Nat Rev Drug Discov 3 11 (2004) 973-977
    • (2004) Nat Rev Drug Discov , vol.3 , Issue.11 , pp. 973-977
    • Whitehead, J.1
  • 10
    • 0031896592 scopus 로고    scopus 로고
    • There are no bad anticancer agents, only bad clinical trial designs: Twenty-First Richard and Hinda Rosenthal Foundation Award Lecture
    • Von Hoff D.D. There are no bad anticancer agents, only bad clinical trial designs: Twenty-First Richard and Hinda Rosenthal Foundation Award Lecture. Clin Cancer Res 4 (1998) 1079-1086
    • (1998) Clin Cancer Res , vol.4 , pp. 1079-1086
    • Von Hoff, D.D.1
  • 11
    • 33846504444 scopus 로고    scopus 로고
    • Compressing drug development timelines in oncology using phase '0' trials
    • Kummar S., Kinders R., Rubinstien L., et al. Compressing drug development timelines in oncology using phase '0' trials. Nat Rev Cancer 7 2 (2007) 131-139
    • (2007) Nat Rev Cancer , vol.7 , Issue.2 , pp. 131-139
    • Kummar, S.1    Kinders, R.2    Rubinstien, L.3
  • 12
    • 33751559373 scopus 로고    scopus 로고
    • Phase I studies of chemotherapeutic agents in cancer patients: a review of the designs
    • Potter D.M. Phase I studies of chemotherapeutic agents in cancer patients: a review of the designs. J Biopharm Stat 16 5 (2006) 579-604
    • (2006) J Biopharm Stat , vol.16 , Issue.5 , pp. 579-604
    • Potter, D.M.1
  • 13
    • 33751560099 scopus 로고    scopus 로고
    • Phase I trial design and methodology for anticancer drugs
    • Teicher B.A., and Andrews P.A. (Eds), Humana Press, Totowa (NJ)
    • Acevedo P.V., Toppmeyer D.L., and Rubin E.H. Phase I trial design and methodology for anticancer drugs. In: Teicher B.A., and Andrews P.A. (Eds). Anticancer drug development guide. 2nd edition (2004), Humana Press, Totowa (NJ) 351-362
    • (2004) Anticancer drug development guide. 2nd edition , pp. 351-362
    • Acevedo, P.V.1    Toppmeyer, D.L.2    Rubin, E.H.3
  • 14
    • 26844522727 scopus 로고    scopus 로고
    • Veterinary Co-Operative Oncology Group-common terminology criteria for adverse events following chemotherapy or biological antineoplastic therapy in dogs and cats
    • Vail D.M. Veterinary Co-Operative Oncology Group-common terminology criteria for adverse events following chemotherapy or biological antineoplastic therapy in dogs and cats. Veterinary and Comparative Oncology 2 4 (2004) 194-213
    • (2004) Veterinary and Comparative Oncology , vol.2 , Issue.4 , pp. 194-213
    • Vail, D.M.1
  • 15
    • 27644526910 scopus 로고    scopus 로고
    • Systemic administration of an attenuated, tumor-targeting Salmonella typhimurium to dogs with spontaneous neoplasia: phase I evaluation
    • Thamm D.H., Kurzman I.D., King I., et al. Systemic administration of an attenuated, tumor-targeting Salmonella typhimurium to dogs with spontaneous neoplasia: phase I evaluation. Clin Cancer Res 11 (2005) 4827-4834
    • (2005) Clin Cancer Res , vol.11 , pp. 4827-4834
    • Thamm, D.H.1    Kurzman, I.D.2    King, I.3
  • 18
    • 0041629016 scopus 로고    scopus 로고
    • Targeting the lung: preclinical and comparative evaluation of anticancer aerosols in dogs with naturally occurring cancers
    • Khanna C., and Vail D.M. Targeting the lung: preclinical and comparative evaluation of anticancer aerosols in dogs with naturally occurring cancers. Curr Cancer Drug Targets 3 (2003) 265-273
    • (2003) Curr Cancer Drug Targets , vol.3 , pp. 265-273
    • Khanna, C.1    Vail, D.M.2
  • 19
    • 0036192228 scopus 로고    scopus 로고
    • Preclinical study of dolastatin-10 in dogs with spontaneous neoplasia
    • Thamm D.H., MacEwen E.G., Phillips B.S., et al. Preclinical study of dolastatin-10 in dogs with spontaneous neoplasia. Cancer Chemother Pharmacol 49 (2002) 251-255
    • (2002) Cancer Chemother Pharmacol , vol.49 , pp. 251-255
    • Thamm, D.H.1    MacEwen, E.G.2    Phillips, B.S.3
  • 20
    • 0031047788 scopus 로고    scopus 로고
    • Preclinical trial of doxorubicin entrapped in sterically stabilized liposomes in dogs with spontaneously arising malignant tumors
    • Vail D.M., Kravis L.D., Cooley A.J., et al. Preclinical trial of doxorubicin entrapped in sterically stabilized liposomes in dogs with spontaneously arising malignant tumors. Cancer Chemother Pharmacol 39 (1997) 410-416
    • (1997) Cancer Chemother Pharmacol , vol.39 , pp. 410-416
    • Vail, D.M.1    Kravis, L.D.2    Cooley, A.J.3
  • 21
    • 0032853556 scopus 로고    scopus 로고
    • Inhalation chemotherapy for macroscopic primary or metastatic lung tumors: proof of principle in a companion animal model
    • Hershey A.E., Kurzman I.D., Bohling C., et al. Inhalation chemotherapy for macroscopic primary or metastatic lung tumors: proof of principle in a companion animal model. Clin Cancer Res 5 (1999) 2653-2659
    • (1999) Clin Cancer Res , vol.5 , pp. 2653-2659
    • Hershey, A.E.1    Kurzman, I.D.2    Bohling, C.3
  • 22
    • 33947212925 scopus 로고    scopus 로고
    • Phase I study of inhaled doxorubicin for patients with metastatic tumors to the lungs
    • Otterson G.A., Villalona-Calero M.A., Sharma S., et al. Phase I study of inhaled doxorubicin for patients with metastatic tumors to the lungs. Clin Cancer Res 13 4 (2007) 1246-1252
    • (2007) Clin Cancer Res , vol.13 , Issue.4 , pp. 1246-1252
    • Otterson, G.A.1    Villalona-Calero, M.A.2    Sharma, S.3
  • 23
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trial
    • Simon R. Optimal two-stage designs for phase II clinical trial. Control Clin Trials 10 1 (1989) 1-10
    • (1989) Control Clin Trials , vol.10 , Issue.1 , pp. 1-10
    • Simon, R.1
  • 24
    • 34247860864 scopus 로고    scopus 로고
    • Phase II trials published in 2002: a cross-specialty comparison showing significant design differences between oncology trials and other medical specialties
    • Michaelis L.C., and Ratain M.J. Phase II trials published in 2002: a cross-specialty comparison showing significant design differences between oncology trials and other medical specialties. Clin Cancer Res 13 8 (2007) 2400-2405
    • (2007) Clin Cancer Res , vol.13 , Issue.8 , pp. 2400-2405
    • Michaelis, L.C.1    Ratain, M.J.2
  • 25
    • 33646239403 scopus 로고    scopus 로고
    • Phase II clinical trial design: methods in translational research from the Genitourinary Committee at the Eastern Cooperative Oncology Group
    • Gray R., Manola J., Saxman S., et al. Phase II clinical trial design: methods in translational research from the Genitourinary Committee at the Eastern Cooperative Oncology Group. Clin Cancer Res 12 7 (2006) 1966-1969
    • (2006) Clin Cancer Res , vol.12 , Issue.7 , pp. 1966-1969
    • Gray, R.1    Manola, J.2    Saxman, S.3
  • 26
    • 22344447501 scopus 로고    scopus 로고
    • Randomized phase II designs in cancer clinical trials: current status and future directions
    • Lee J.J., and Feng L. Randomized phase II designs in cancer clinical trials: current status and future directions. J Clin Oncol 23 19 (2005) 4450-4457
    • (2005) J Clin Oncol , vol.23 , Issue.19 , pp. 4450-4457
    • Lee, J.J.1    Feng, L.2
  • 27
    • 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 E.A. 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 (1961) 346-353
    • (1961) J Chronic Dis , vol.13 , pp. 346-353
    • Gehan, E.A.1
  • 28
    • 0020108590 scopus 로고
    • One sample multiple testing procedure for phase AII clinical trials
    • Fleming T.R. One sample multiple testing procedure for phase AII clinical trials. Biometrics 38 (1982) 143-151
    • (1982) Biometrics , vol.38 , pp. 143-151
    • Fleming, T.R.1
  • 29
    • 0034594628 scopus 로고    scopus 로고
    • New guidelines to evaluate the response to treatment in solid tumors
    • Therasse P., Arbuck S.G., Eisenhauer E.A., et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92 3 (2000) 205-216
    • (2000) J Natl Cancer Inst , vol.92 , Issue.3 , pp. 205-216
    • Therasse, P.1    Arbuck, S.G.2    Eisenhauer, E.A.3
  • 30
    • 35348824554 scopus 로고    scopus 로고
    • WHO handbook for reporting results of cancer treatment. Geneva (Switzerland): World Health Organizations Offset Publication No. 48; 1979.
  • 31
    • 0036834056 scopus 로고    scopus 로고
    • Liposome-encapsulated doxorubicin (Doxil R) and doxorubicin in the treatment of vaccine-associated sarcoma in cats
    • Poirier V.J., Kurzman I.D., Thamm D.K., et al. Liposome-encapsulated doxorubicin (Doxil R) and doxorubicin in the treatment of vaccine-associated sarcoma in cats. J Vet Intern Med 16 (2002) 726-731
    • (2002) J Vet Intern Med , vol.16 , pp. 726-731
    • Poirier, V.J.1    Kurzman, I.D.2    Thamm, D.K.3
  • 32
    • 0037389779 scopus 로고    scopus 로고
    • Long-term survival of dogs with advanced malignant melanoma after DNA vaccination with xenogeneic human tyrosinase
    • Bergman P.J., McKnight J., Novosad A., et al. Long-term survival of dogs with advanced malignant melanoma after DNA vaccination with xenogeneic human tyrosinase. Clin Cancer Res 9 (2003) 1284-1290
    • (2003) Clin Cancer Res , vol.9 , pp. 1284-1290
    • Bergman, P.J.1    McKnight, J.2    Novosad, A.3
  • 33
    • 30444448739 scopus 로고    scopus 로고
    • Development of an allogeneic whole-cell tumor vaccine expressing xenogeneic gp100 and its implementation in a phase II clinical trial in canine patients with malignant melanoma
    • Alexander A.N., Huelsmeyer M.K., Mitzey M., et al. Development of an allogeneic whole-cell tumor vaccine expressing xenogeneic gp100 and its implementation in a phase II clinical trial in canine patients with malignant melanoma. Cancer Immunol Immunother 55 (2006) 433-442
    • (2006) Cancer Immunol Immunother , vol.55 , pp. 433-442
    • Alexander, A.N.1    Huelsmeyer, M.K.2    Mitzey, M.3
  • 34
    • 0031749555 scopus 로고    scopus 로고
    • Efficacy of pyridoxine to ameliorate the cutaneous toxicity associated with doxorubicin containing pegylated (stealth) liposomes: a randomized, double-blind clinical trial using a canine model
    • Vail D.M., Chun R., Thamm D.H., et al. Efficacy of pyridoxine to ameliorate the cutaneous toxicity associated with doxorubicin containing pegylated (stealth) liposomes: a randomized, double-blind clinical trial using a canine model. Clin Cancer Res 4 (1998) 1567-1571
    • (1998) Clin Cancer Res , vol.4 , pp. 1567-1571
    • Vail, D.M.1    Chun, R.2    Thamm, D.H.3
  • 35
    • 26044474374 scopus 로고    scopus 로고
    • The phase III clinical cancer trial
    • Teicher B.A., and Andrews P.A. (Eds), Humana Press, Totowa (NJ)
    • Dagher R.N., and Pazdur R. The phase III clinical cancer trial. In: Teicher B.A., and Andrews P.A. (Eds). Anticancer drug development guide. 2nd edition (2004), Humana Press, Totowa (NJ) 401-410
    • (2004) Anticancer drug development guide. 2nd edition , pp. 401-410
    • Dagher, R.N.1    Pazdur, R.2
  • 36
    • 0036351312 scopus 로고    scopus 로고
    • Stealth liposomal cisplatin versus carboplatin as adjuvant therapy for spontaneously arising osteosarcoma in the dog: a randomized multicenter clinical trial
    • Vail D.M., Kurzman I.D., Glawe P.A., et al. Stealth liposomal cisplatin versus carboplatin as adjuvant therapy for spontaneously arising osteosarcoma in the dog: a randomized multicenter clinical trial. Cancer Chemother Pharmacol 50 (2002) 131-136
    • (2002) Cancer Chemother Pharmacol , vol.50 , pp. 131-136
    • Vail, D.M.1    Kurzman, I.D.2    Glawe, P.A.3
  • 38
    • 0034033796 scopus 로고    scopus 로고
    • Can unequal be more fair? A response to Andrew Avins
    • 10.1136/jme.26.3.179
    • Edwards S., and Braunholtz D. Can unequal be more fair? A response to Andrew Avins. J Med Ethics 26 (2000) 179-182 10.1136/jme.26.3.179
    • (2000) J Med Ethics , vol.26 , pp. 179-182
    • Edwards, S.1    Braunholtz, D.2
  • 39
    • 0031764879 scopus 로고    scopus 로고
    • Can unequal be more fair? Ethics, subject allocation, and randomised clinical trials
    • Avins A.L. Can unequal be more fair? Ethics, subject allocation, and randomised clinical trials. J Med Ethics 24 (1998) 401-408
    • (1998) J Med Ethics , vol.24 , pp. 401-408
    • Avins, A.L.1
  • 40
    • 0034762257 scopus 로고    scopus 로고
    • Intention-to-treat principle
    • Montori V.M., and Guyatt G.H. Intention-to-treat principle. Can Med Assoc J 165 10 (2001) 1339-1341
    • (2001) Can Med Assoc J , vol.165 , Issue.10 , pp. 1339-1341
    • Montori, V.M.1    Guyatt, G.H.2
  • 41
    • 0037151796 scopus 로고    scopus 로고
    • Post-randomization exclusion: the intention to treat principle and excluding patients from analysis
    • Fergusson D., Aaron S.D., Guyatt G., et al. Post-randomization exclusion: the intention to treat principle and excluding patients from analysis. Br Med J 325 7365 (2002) 652-655
    • (2002) Br Med J , vol.325 , Issue.7365 , pp. 652-655
    • Fergusson, D.1    Aaron, S.D.2    Guyatt, G.3
  • 42
    • 33745406564 scopus 로고    scopus 로고
    • Slow start to phase 0 as researchers debate value
    • Twombly R. Slow start to phase 0 as researchers debate value. J Natl Cancer Inst 98 12 (2006) 804-806
    • (2006) J Natl Cancer Inst , vol.98 , Issue.12 , pp. 804-806
    • Twombly, R.1
  • 43
    • 0035316571 scopus 로고    scopus 로고
    • Design considerations for efficient prostate cancer chemoprevention trials
    • Lee J.J., Lieberman R., Sloan J.A., et al. Design considerations for efficient prostate cancer chemoprevention trials. Urology 57 4 Suppl 1 (2001) 206-212
    • (2001) Urology , vol.57 , Issue.4 SUPPL. 1 , pp. 206-212
    • Lee, J.J.1    Lieberman, R.2    Sloan, J.A.3
  • 44
    • 0031032503 scopus 로고    scopus 로고
    • o embedded in sequential tests
    • o embedded in sequential tests. Stat Med 16 (1997) 465-477
    • (1997) Stat Med , vol.16 , pp. 465-477
    • Betensky, R.A.1
  • 45
    • 25444474448 scopus 로고    scopus 로고
    • A review of methods for futility stopping based on conditional power
    • Lachin J.M. A review of methods for futility stopping based on conditional power. Stat Med 24 (2004) 2747-2764
    • (2004) Stat Med , vol.24 , pp. 2747-2764
    • Lachin, J.M.1
  • 46
    • 33644861229 scopus 로고    scopus 로고
    • Bayesian clinical trials
    • Berry D.A. Bayesian clinical trials. Nat Rev Drug Discov 5 (2006) 27-36
    • (2006) Nat Rev Drug Discov , vol.5 , pp. 27-36
    • Berry, D.A.1
  • 47
    • 0032977508 scopus 로고    scopus 로고
    • Use of predictive probabilities in phase II and phase III clinical trials
    • Johns D., and Andersen J.S. Use of predictive probabilities in phase II and phase III clinical trials. J Biopharm Stat 9 (1999) 67-69
    • (1999) J Biopharm Stat , vol.9 , pp. 67-69
    • Johns, D.1    Andersen, J.S.2
  • 48
    • 0028887994 scopus 로고
    • Adaptive assignment versus balanced randomization in clinical trials: a decision analysis
    • Berry D.A., and Eick S.G. Adaptive assignment versus balanced randomization in clinical trials: a decision analysis. Stat Med 14 (1995) 231-246
    • (1995) Stat Med , vol.14 , pp. 231-246
    • Berry, D.A.1    Eick, S.G.2
  • 49
    • 0037445360 scopus 로고    scopus 로고
    • Hierarchical Bayesian approaches to phase II trials in diseases with multiple subtypes
    • Thall P.F., Wathen J.K., Bekele B.N., et al. Hierarchical Bayesian approaches to phase II trials in diseases with multiple subtypes. Stat Med 22 (2003) 763-780
    • (2003) Stat Med , vol.22 , pp. 763-780
    • Thall, P.F.1    Wathen, J.K.2    Bekele, B.N.3
  • 50
    • 0036968867 scopus 로고    scopus 로고
    • Seamlessly expanding a randomized phase II trial to phase III
    • Inoue L.Y., Thall P.F., and Berry D.A. Seamlessly expanding a randomized phase II trial to phase III. Biometrics 58 (2002) 823-831
    • (2002) Biometrics , vol.58 , pp. 823-831
    • Inoue, L.Y.1    Thall, P.F.2    Berry, D.A.3
  • 51
    • 0032885857 scopus 로고    scopus 로고
    • Decision theoretic designs for phase II clinical trials with multiple outcomes
    • Stallard N., Thall P.F., and Whitehead J. Decision theoretic designs for phase II clinical trials with multiple outcomes. Biometrics 55 (1999) 971-977
    • (1999) Biometrics , vol.55 , pp. 971-977
    • Stallard, N.1    Thall, P.F.2    Whitehead, J.3
  • 52
    • 20544460650 scopus 로고    scopus 로고
    • Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy; results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer
    • Buzdar A.U., Ibrahim N.K., Francis D., et al. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy; results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol 23 16 (2005) 3676-3685
    • (2005) J Clin Oncol , vol.23 , Issue.16 , pp. 3676-3685
    • Buzdar, A.U.1    Ibrahim, N.K.2    Francis, D.3
  • 53
    • 34248193851 scopus 로고    scopus 로고
    • The randomized discontinuation trial: a phase II design to assess growth-inhibitory agents
    • Stadler W.M. The randomized discontinuation trial: a phase II design to assess growth-inhibitory agents. Mol Cancer Ther 6 4 (2007) 1180-1185
    • (2007) Mol Cancer Ther , vol.6 , Issue.4 , pp. 1180-1185
    • Stadler, W.M.1
  • 54
    • 20544432488 scopus 로고    scopus 로고
    • Successful implementation of the randomized discontinuation trial design: an application to the study of the putative antiangiogenic agent carboxyaminoimidazole in renal cell carcinoma-CALGB 69901
    • Stadler W.M., Rosner G., Small E., et al. Successful implementation of the randomized discontinuation trial design: an application to the study of the putative antiangiogenic agent carboxyaminoimidazole in renal cell carcinoma-CALGB 69901. J Clin Oncol 23 16 (2005) 3726-3732
    • (2005) J Clin Oncol , vol.23 , Issue.16 , pp. 3726-3732
    • Stadler, W.M.1    Rosner, G.2    Small, E.3
  • 55
    • 0037112181 scopus 로고    scopus 로고
    • Randomized discontinuation design: application to cytostatic antineoplastic agents
    • Rosner G.L., Stadler W., and Ratain M.J. Randomized discontinuation design: application to cytostatic antineoplastic agents. J Clin Oncol 20 22 (2002) 4478-4484
    • (2002) J Clin Oncol , vol.20 , Issue.22 , pp. 4478-4484
    • Rosner, G.L.1    Stadler, W.2    Ratain, M.J.3
  • 56
    • 35348908204 scopus 로고    scopus 로고
    • A parallel phase I/II clinical trial design for combination therapies
    • Huang X., Biswas S., Oki Y., et al. A parallel phase I/II clinical trial design for combination therapies. Biometrics (2006) 1-8
    • (2006) Biometrics , pp. 1-8
    • Huang, X.1    Biswas, S.2    Oki, Y.3
  • 57
    • 33750854113 scopus 로고    scopus 로고
    • Adaptive seamless phase II/III designs-background, operational aspects and examples
    • Maca J. Adaptive seamless phase II/III designs-background, operational aspects and examples. Drug Inf J 40 04 (2006) 463-474
    • (2006) Drug Inf J , vol.40 , Issue.4 , pp. 463-474
    • Maca, J.1
  • 58
    • 33748521268 scopus 로고    scopus 로고
    • Confirmatory seamless phase II/III clinical trials with hypothesis selection at interim: general concepts
    • Bretz F., Schmidli H., Konig F., et al. Confirmatory seamless phase II/III clinical trials with hypothesis selection at interim: general concepts. Biom J 48 4 (2006) 623-634
    • (2006) Biom J , vol.48 , Issue.4 , pp. 623-634
    • Bretz, F.1    Schmidli, H.2    Konig, F.3
  • 59
    • 0035869407 scopus 로고    scopus 로고
    • Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2
    • Slamon D.J., Leyland-Jones B., Shak S., et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344 11 (2001) 783-792
    • (2001) N Engl J Med , vol.344 , Issue.11 , pp. 783-792
    • Slamon, D.J.1    Leyland-Jones, B.2    Shak, S.3
  • 60
    • 20944444824 scopus 로고    scopus 로고
    • The development and application of imatinib
    • Jones R.L., and Judson I.R. The development and application of imatinib. Expert Opin Drug Saf 4 2 (2005) 183-191
    • (2005) Expert Opin Drug Saf , vol.4 , Issue.2 , pp. 183-191
    • Jones, R.L.1    Judson, I.R.2
  • 61
    • 33947206730 scopus 로고    scopus 로고
    • Noninferiority testing beyond simple two-sample comparison
    • Tsong Y., and Chen W.J. Noninferiority testing beyond simple two-sample comparison. J Biopharm Stat 17 2 (2007) 289-308
    • (2007) J Biopharm Stat , vol.17 , Issue.2 , pp. 289-308
    • Tsong, Y.1    Chen, W.J.2
  • 62
    • 33646418976 scopus 로고    scopus 로고
    • Communication and informed consent in phase 1 trials: a review of the literature
    • Cox A.C., Fallowfield L.J., and Jenkins V.A. Communication and informed consent in phase 1 trials: a review of the literature. Support Care Cancer 14 4 (2006) 303-309
    • (2006) Support Care Cancer , vol.14 , Issue.4 , pp. 303-309
    • Cox, A.C.1    Fallowfield, L.J.2    Jenkins, V.A.3
  • 63
    • 33645307757 scopus 로고    scopus 로고
    • How participants in cancer trials are chosen: ethics and conflicting interests
    • Jayson G., and Harris J. How participants in cancer trials are chosen: ethics and conflicting interests. Nat Rev Cancer 6 4 (2006) 330-336
    • (2006) Nat Rev Cancer , vol.6 , Issue.4 , pp. 330-336
    • Jayson, G.1    Harris, J.2
  • 65
    • 35348889288 scopus 로고    scopus 로고
    • Morris Animal Foundations. Available at: www.morrisanimalfoundation.org/reports/grants/full_proposal/Established_Investigator_guidelines.pdf.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.