The Brave New World of clinical cancer research: Adaptive biomarker-driven trials integrating clinical practice with clinical research

被引:98
作者
Berry, Donald A. [1 ]
机构
[1] Univ Texas MD Anderson Canc Ctr, Div Quantitat Sci, Houston, TX USA
关键词
Biomarker-driven clinical trials; Platform trials; Basket trials; Bayesian adaptive clinical trials; PERSONALIZED MEDICINE; LUNG-CANCER; FREE SURVIVAL; BATTLE TRIAL; THERAPY; DESIGN;
D O I
10.1016/j.molonc.2015.02.011
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Clinical trials are the final links in the chains of knowledge and for determining the roles of therapeutic advances. Unfortunately, in an important sense they are the weakest links. This article describes two designs that are being explored today: platform trials and basket trials. Both are attempting to merge clinical research and clinical practice. (C) 2015 Federation of European Biochemical Societies. Published by Elsevier B.V. All rights reserved.
引用
收藏
页码:951 / 959
页数:9
相关论文
共 25 条
[1]  
Abrams J, 2014, AM SOC CLIN ONCOL ED, V34, P71
[2]  
[Anonymous], 2011, DRIVING BIOMEDICAL I
[3]  
[Anonymous], BELM REP ETH PRINC G
[4]   I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy [J].
Barker, A. D. ;
Sigman, C. C. ;
Kelloff, G. J. ;
Hylton, N. M. ;
Berry, D. A. ;
Esserman, L. J. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2009, 86 (01) :97-100
[5]   Bayesian clinical trials [J].
Berry, DA .
NATURE REVIEWS DRUG DISCOVERY, 2006, 5 (01) :27-36
[6]   Adaptive clinical trials in oncology [J].
Berry, Donald A. .
NATURE REVIEWS CLINICAL ONCOLOGY, 2012, 9 (04) :199-207
[7]   Reports from the 2010 Clinical and Translational Cancer Research Think Tank Meeting: Design Strategies for Personalized Therapy Trials [J].
Berry, Donald A. ;
Herbst, Roy S. ;
Rubin, Eric H. .
CLINICAL CANCER RESEARCH, 2012, 18 (03) :638-644
[8]   Bayesian hierarchical modeling of patient subpopulations: Efficient designs of Phase II oncology clinical trials [J].
Berry, Scott M. ;
Broglio, Kristine R. ;
Groshen, Susan ;
Berry, Donald A. .
CLINICAL TRIALS, 2013, 10 (05) :720-734
[9]   Detecting an Overall Survival Benefit that Is Derived From Progression-Free Survival [J].
Broglio, Kristine R. ;
Berry, Donald A. .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2009, 101 (23) :1642-1649
[10]   Pathologic Complete Response Predicts Recurrence-Free Survival More Effectively by Cancer Subset: Results From the I-SPY 1 TRIAL-CALGB 150007/150012, ACRIN 6657 [J].
Esserman, Laura J. ;
Berry, Donald A. ;
DeMichele, Angela ;
Carey, Lisa ;
Davis, Sarah E. ;
Buxton, Meredith ;
Hudis, Cliff ;
Gray, Joe W. ;
Perou, Charles ;
Yau, Christina ;
Livasy, Chad ;
Krontiras, Helen ;
Montgomery, Leslie ;
Tripathy, Debasish ;
Lehman, Constance ;
Liu, Minetta C. ;
Olopade, Olufunmilayo I. ;
Rugo, Hope S. ;
Carpenter, John T. ;
Dressler, Lynn ;
Chhieng, David ;
Singh, Baljit ;
Mies, Carolyn ;
Rabban, Joseph ;
Chen, Yunn-Yi ;
Giri, Dilip ;
van 't Veer, Laura ;
Hylton, Nola .
JOURNAL OF CLINICAL ONCOLOGY, 2012, 30 (26) :3242-3249