Phases I;
II and III oncology clinical trials;
Trial designs;
Safety and efficacy endpoints;
PK/PD modeling;
Statistical analyses;
CONTINUAL REASSESSMENT METHOD;
RESPONSE EVALUATION CRITERIA;
ANTIBODY-DRUG CONJUGATE;
TOXICITY TRADE-OFFS;
PRACTICAL CONSIDERATIONS;
TRASTUZUMAB EMTANSINE;
HYPOTHESES SELECTION;
INTERIM ANALYSES;
DOSE-ESCALATION;
2-STAGE DESIGNS;
D O I:
10.1016/j.critrevonc.2013.03.007
中图分类号:
R73 [肿瘤学];
学科分类号:
100214 ;
摘要:
Cancer is a disease that occurs due to the uncontrolled multiplication of cells that invade nearby tissues and can spread to other parts of the body. An increased incidence of cancer in the world has led to an increase in oncology research and in the number of oncology trials. Well designed oncology clinical trials are a key part of developing effective anti-cancer drugs. This-review focuses on statistical considerations in the design and analysis of oncology clinical trials. (C) 2013 Elsevier Ireland Ltd. All rights reserved.
机构:
Inst Claudius Regaud IUCT O, Biostat Unit, Toulouse, FranceInst Claudius Regaud IUCT O, Biostat Unit, Toulouse, France
Cabarrou, Bastien
Sfumato, Patrick
论文数: 0引用数: 0
h-index: 0
机构:
Inst Paoli Calmettes, Biostat Unit, Marseille, FranceInst Claudius Regaud IUCT O, Biostat Unit, Toulouse, France
Sfumato, Patrick
Mourey, Loic
论文数: 0引用数: 0
h-index: 0
机构:
Inst Claudius Regaud IUCT O, Med Oncol Dept, Toulouse, FranceInst Claudius Regaud IUCT O, Biostat Unit, Toulouse, France
Mourey, Loic
Leconte, Eve
论文数: 0引用数: 0
h-index: 0
机构:
Univ Toulouse 1 Capitole, TSE R, Toulouse, FranceInst Claudius Regaud IUCT O, Biostat Unit, Toulouse, France
Leconte, Eve
Balardy, Laurent
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h-index: 0
机构:
CHU Toulouse, Dept Geriatr, Toulouse, FranceInst Claudius Regaud IUCT O, Biostat Unit, Toulouse, France
Balardy, Laurent
Martinez, Alejandra
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h-index: 0
机构:
Inst Claudius Regaud IUCT O, Dept Surg, Toulouse, FranceInst Claudius Regaud IUCT O, Biostat Unit, Toulouse, France
Martinez, Alejandra
Delord, Jean-Pierre
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h-index: 0
机构:
Inst Claudius Regaud IUCT O, Med Oncol Dept, Toulouse, FranceInst Claudius Regaud IUCT O, Biostat Unit, Toulouse, France
Delord, Jean-Pierre
Boher, Jean-Marie
论文数: 0引用数: 0
h-index: 0
机构:
Inst Paoli Calmettes, Biostat Unit, Marseille, France
Aix Marseille Univ, INSERM, IRD, SESSTIM, Marseille, FranceInst Claudius Regaud IUCT O, Biostat Unit, Toulouse, France
Boher, Jean-Marie
Brain, Etienne
论文数: 0引用数: 0
h-index: 0
机构:
Inst Curie St Cloud, Dept Med Oncol, St Cloud, FranceInst Claudius Regaud IUCT O, Biostat Unit, Toulouse, France
Brain, Etienne
Filleron, Thomas
论文数: 0引用数: 0
h-index: 0
机构:
Inst Claudius Regaud IUCT O, Biostat Unit, Toulouse, FranceInst Claudius Regaud IUCT O, Biostat Unit, Toulouse, France
机构:
Hacettepe Univ, Fac Med, Dept Med Oncol, TR-06100 Ankara, TurkeyHacettepe Univ, Fac Med, Dept Med Oncol, TR-06100 Ankara, Turkey
Kilickap, Saadettin
Demirci, Umut
论文数: 0引用数: 0
h-index: 0
机构:
Saglik Bilimleri Univ, Dept Med Oncol, Dr Abdurrahman Yurtaslan Ankara Oncol Training &, Ankara, TurkeyHacettepe Univ, Fac Med, Dept Med Oncol, TR-06100 Ankara, Turkey
Demirci, Umut
Karadurmus, Nuri
论文数: 0引用数: 0
h-index: 0
机构:
Saglik Bilimleri Univ, Dept Med Oncol, Fac Med, Ankara, TurkeyHacettepe Univ, Fac Med, Dept Med Oncol, TR-06100 Ankara, Turkey
Karadurmus, Nuri
Dogan, Mutlu
论文数: 0引用数: 0
h-index: 0
机构:
Ankara Numune Training & Res Hosp, Dept Med Oncol, Ankara, TurkeyHacettepe Univ, Fac Med, Dept Med Oncol, TR-06100 Ankara, Turkey
Dogan, Mutlu
Akinci, Bulent
论文数: 0引用数: 0
h-index: 0
机构:
Yildirim Beyazit Univ, Fac Med, Dept Med Oncol, Ankara, TurkeyHacettepe Univ, Fac Med, Dept Med Oncol, TR-06100 Ankara, Turkey
Akinci, Bulent
Sendur, Mehmet Ali Nahit
论文数: 0引用数: 0
h-index: 0
机构:
Yildirim Beyazit Univ, Fac Med, Dept Med Oncol, Ankara, TurkeyHacettepe Univ, Fac Med, Dept Med Oncol, TR-06100 Ankara, Turkey
机构:
Jackson Lab Genom Med, Farmington, CT USAJackson Lab Genom Med, Farmington, CT USA
Mockus, Susan M.
Patterson, Sara E.
论文数: 0引用数: 0
h-index: 0
机构:
Jackson Lab Genom Med, Farmington, CT USAJackson Lab Genom Med, Farmington, CT USA
Patterson, Sara E.
Statz, Cara
论文数: 0引用数: 0
h-index: 0
机构:
Jackson Lab Genom Med, Farmington, CT USAJackson Lab Genom Med, Farmington, CT USA
Statz, Cara
Bult, Carol J.
论文数: 0引用数: 0
h-index: 0
机构:
Jackson Lab, 600 Main St, Bar Harbor, ME 04609 USAJackson Lab Genom Med, Farmington, CT USA
Bult, Carol J.
Tsongalis, Gregory J.
论文数: 0引用数: 0
h-index: 0
机构:
Dartmouth Hitchcock Med Ctr, Lebanon, NH 03766 USA
Audrey & Theodor Geisel Sch Med Dartmouth, Lebanon, NH USAJackson Lab Genom Med, Farmington, CT USA