Deciphering the EU clinical trials regulation

被引：16
作者：
Abou-El-Enein, Mohamed [1 ]
Schneider, Christian K. [2 ,3 ]
机构：
[1] Charite, Berlin Brandenburg Ctr Regenerat Therapies BCRT, Campus Virchow, D-13353 Berlin, Germany
[2] Med & Healthcare Prod Regulatory Agcy, NIBSC, S Mimms, Herts, England
[3] Twincore Ctr Expt & Clin Infect Res, Hannover, Germany
来源：
NATURE BIOTECHNOLOGY | 2016年 / 34卷 / 03期
关键词：
D O I：
10.1038/nbt.3492
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
引用
收藏
页码：231 / 233
页数：3
相关论文
共 8 条
[1]   A roadmap toward clinical translation of genetically-modified stem cells for treatment of HIV [J].
Abou-El-Enein, Mohamed ;
Bauer, Gerhard ;
Reinke, Petra ;
Renner, Matthias ;
Schneider, Christian K. .
TRENDS IN MOLECULAR MEDICINE, 2014, 20 (11) :632-642
[2]   Genome Editing Technologies: Defining a Path to Clinic [J].
Corrigan-Curay, Jacqueline ;
O'Reilly, Marina ;
Kohn, Donald B. ;
Cannon, Paula M. ;
Bao, Gang ;
Bushman, Frederic D. ;
Carroll, Dana ;
Cathomen, Toni ;
Joung, J. Keith ;
Roth, David ;
Sadelain, Michel ;
Scharenberg, Andrew M. ;
von Kalle, Christof ;
Zhang, Feng ;
Jambou, Robert ;
Rosenthal, Eugene ;
Hassani, Morad ;
Singh, Aparna ;
Porteus, Matthew H. .
MOLECULAR THERAPY, 2015, 23 (05) :796-806
[3]   Has the European Clinical Trials Directive been a success? [J].
Frewer, L. J. ;
Coles, D. ;
Champion, K. ;
Demotes-Mainard, J. ;
Goetbuget, N. ;
Ihrig, K. ;
Klingmann, I. ;
Kubiak, C. ;
Lejeune, S. A. ;
McDonald, F. ;
Apperley, J. .
BRITISH MEDICAL JOURNAL, 2010, 340
[4]   Ethical and Scientific Implications of the Globalization of Clinical Research [J].
Glickman, Seth W. ;
McHutchison, John G. ;
Peterson, Eric D. ;
Cairns, Charles B. ;
Harrington, Robert A. ;
Califf, Robert M. ;
Schulman, Kevin A. .
NEW ENGLAND JOURNAL OF MEDICINE, 2009, 360 (08) :816-823
[5]   The health of European medical research - Attempts are under way to update EU regulations, with the aim of harmonizing clinical research across the continent [J].
Hunter, Philip .
EMBO REPORTS, 2011, 12 (02) :110-112
[6]   Evidence-informed recommendations to reduce dissemination bias in clinical research: conclusions from the OPEN (Overcome failure to Publish nEgative fiNdings) project based on an international consensus meeting [J].
Meerpohl, Joerg J. ;
Schell, Lisa K. ;
Bassler, Dirk ;
Gallus, Silvano ;
Kleijnen, Jos ;
Kulig, Michael ;
La Vecchia, Carlo ;
Marusic, Ana ;
Ravaud, Philippe ;
Reis, Andreas ;
Schmucker, Christine ;
Strech, Daniel ;
Urrutia, Gerard ;
Wager, Elizabeth ;
Antes, Gerd .
BMJ OPEN, 2015, 5 (05)
[7]   Preparing for Responsible Sharing of Clinical Trial Data [J].
Mello, Michelle M. ;
Francer, Jeffrey K. ;
Wilenzick, Marc ;
Teden, Patricia ;
Bierer, Barbara E. ;
Barnes, Mark .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (17) :1651-1658
[8]   Challenges with advanced therapy medicinal products and how to meet them [J].
Schneider, Christian K. ;
Salmikangas, Paula ;
Jilma, Bernd ;
Flamion, Bruno ;
Todorova, Lyubina Racheva ;
Paphitou, Anna ;
Haunerova, Ivana ;
Maimets, Toivo ;
Trouvin, Jean-Hugues ;
Flory, Egbert ;
Tsiftsoglou, Asterios ;
Gudmundsson, Kolbeinn ;
O'Donovan, Maura ;
Migliaccio, Giovanni ;
Ancans, Janis ;
Maciulaitis, Romaldas ;
Robert, Jean-Louis ;
Samuel, Anthony ;
Ovelgoenne, Johannes H. ;
Hystad, Marit ;
Fal, Andrzej Mariusz ;
Lima, Beatriz Silva ;
Moraru, Anca Stela ;
Turcani, Peter ;
Zorec, Robert ;
Ruiz, Sol ;
Akerblom, Lennart ;
Narayanan, Gopalan ;
Kent, Alastair ;
Bignami, Fabrizia ;
Dickson, J. George ;
Niederwieser, Dietger ;
Figuerola-Santos, Maria-Angeles ;
Reischl, Ilona G. ;
Beuneu, Claire ;
Georgiev, Rosen ;
Vassiliou, Maria ;
Pychova, Alena ;
Clausen, Mette ;
Methuen, Taina ;
Lucas, Sophie ;
Schussler-Lenz, Martina ;
Kokkas, Vasilios ;
Buzas, Zsuzsanna ;
MacAleenan, Niall ;
Galli, Maria Cristina ;
Line, Aija ;
Gulbinovic, Jolanta ;
Berchem, Guy ;
Fraczek, Mariusz .
NATURE REVIEWS DRUG DISCOVERY, 2010, 9 (03) :195-201
1