Precision medicine: drowning in a regulatory soup?

被引:18
作者
Nicol, Dianne [1 ]
Bubela, Tania [2 ]
Chalmers, Don [1 ]
Charbonneau, Jan [1 ]
Critchley, Christine [3 ]
Dickinson, Joanne [4 ,7 ]
Fleming, Jennifer [5 ]
Hewitt, Alex W. [4 ]
Kaye, Jane [6 ]
Liddicoat, Johnathon
McWhirter, Rebekah [4 ]
Otlowski, Margaret [1 ]
Ries, Nola M. [8 ]
Skene, Loane [9 ]
Stewart, Cameron [10 ]
Wagner, Jennifer [11 ]
Zeps, Nik [12 ]
机构
[1] Univ Tasmania, Fac Law, Hobart, Tas, Australia
[2] Univ Alberta, Sch Publ Hlth, Edmonton, AB, Canada
[3] Swinburne Univ Technol, Stat Data Sci & Epidemiol, Hawthorn, Vic, Australia
[4] Univ Tasmania, Menzies Inst forMed Res Tasmania, Hobart, Tas, Australia
[5] Univ Sydney, Sch Publ Hlth, Ctr Values Eth & Law Med VELIM, Sydney, NSW, Australia
[6] Univ Oxford, Ctr Hlth Law & Emerging Technol, Oxford, Oxon, England
[7] Univ Cambridge, Fac Law, Cambridge, Cambs, England
[8] Univ Newcastle, Fac Law, Callaghan, NSW, Australia
[9] Univ Melbourne, Fac Law, Melbourne, Vic, Australia
[10] Univ Sydney, Fac Law, Sydney, NSW, Australia
[11] Geisinger Hlth Syst, Bioeth Res, Danville, PA USA
[12] St John God Subiaco Hosp, Dept Pathol, Subiaco, WA, Australia
基金
澳大利亚研究理事会;
关键词
precision medicine; pharmacogenomics; direct-to-consumer genetic analysis; regulation; PERSONALIZED MEDICINE; INCIDENTAL FINDINGS; GENOME; PERSPECTIVE; HEALTH; INTEGRATION; GERMLINE; ISSUES; PATH; FDA;
D O I
10.1093/jlb/lsw018
中图分类号
B82 [伦理学(道德学)];
学科分类号
摘要
[No abstract available]
引用
收藏
页码:281 / 303
页数:23
相关论文
共 95 条
[21]   A New Initiative on Precision Medicine [J].
Collins, Francis S. ;
Varmus, Harold .
NEW ENGLAND JOURNAL OF MEDICINE, 2015, 372 (09) :793-795
[22]  
Conley John M, 2014, N C J Law Technol, V15, P597
[23]   The next controversy in genetic testing: clinical data as trade secrets? [J].
Cook-Deegan, Robert ;
Conley, John M. ;
Evans, James P. ;
Vorhaus, Daniel .
EUROPEAN JOURNAL OF HUMAN GENETICS, 2013, 21 (06) :585-588
[24]   Therapeutic genome editing: prospects and challenges [J].
Cox, David Benjamin Turitz ;
Platt, Randall Jeffrey ;
Zhang, Feng .
NATURE MEDICINE, 2015, 21 (02) :121-131
[25]  
Cyranoski D., 2015, NATURE NEWS, DOI [10.1038/nature.2015.17378, DOI 10.1038/NATURE.2015.17378]
[26]   Translating cancer research into targeted therapeutics [J].
de Bono, J. S. ;
Ashworth, Alan .
NATURE, 2010, 467 (7315) :543-549
[27]   Clinical Integration of Next Generation Sequencing: Coverage and Reimbursement Challenges [J].
Deverka, Patricia A. ;
Dreyfus, Jennifer C. .
JOURNAL OF LAW MEDICINE & ETHICS, 2014, 42 :22-41
[28]   A 2015 update on predictive molecular pathology and its role in targeted cancer therapy: a review focussing on clinical relevance [J].
Dietel, M. ;
Joehrens, K. ;
Laffert, M. V. ;
Hummel, M. ;
Blaeker, H. ;
Pfitzner, B. M. ;
Lehmann, A. ;
Denkert, C. ;
Darb-Esfahani, S. ;
Lenze, D. ;
Heppner, F. L. ;
Koch, A. ;
Sers, C. ;
Klauschen, F. ;
Anagnostopoulos, I. .
CANCER GENE THERAPY, 2015, 22 (09) :417-430
[29]   Genomics in the public domain: strategy and policy [J].
Eisenberg, RS .
NATURE REVIEWS GENETICS, 2000, 1 (01) :70-74
[30]   Evidence gaps and ethical review of multicenter studies [J].
Ervin, Ann-Margret ;
Taylor, Holly A. ;
Meinert, Curtis L. ;
Ehrhardt, Stephan .
SCIENCE, 2015, 350 (6261) :632-633