Literature DB >> 26963541

Deciphering the EU clinical trials regulation.

Mohamed Abou-El-Enein1, Christian K Schneider2,3.   

Abstract

Mesh:

Year:  2016        PMID: 26963541     DOI: 10.1038/nbt.3492

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN: 1087-0156            Impact factor:   54.908


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  8 in total

1.  Has the European Clinical Trials Directive been a success?

Authors:  L J Frewer; D Coles; K Champion; J Demotes-Mainard; N Goetbuget; K Ihrig; I Klingmann; C Kubiak; S A Lejeune; F McDonald; J Apperley
Journal:  BMJ       Date:  2010-04-09

2.  Ethical and scientific implications of the globalization of clinical research.

Authors:  Seth W Glickman; John G McHutchison; Eric D Peterson; Charles B Cairns; Robert A Harrington; Robert M Califf; Kevin A Schulman
Journal:  N Engl J Med       Date:  2009-02-19       Impact factor: 91.245

3.  Preparing for responsible sharing of clinical trial data.

Authors:  Michelle M Mello; Jeffrey K Francer; Marc Wilenzick; Patricia Teden; Barbara E Bierer; Mark Barnes
Journal:  N Engl J Med       Date:  2013-10-21       Impact factor: 91.245

4.  The health of European medical research. Attempts are under way to update EU regulations, with the aim of harmonizing clinical research across the continent.

Authors:  Philip Hunter
Journal:  EMBO Rep       Date:  2011-02       Impact factor: 8.807

Review 5.  Challenges with advanced therapy medicinal products and how to meet them.

Authors:  Christian K Schneider; Paula Salmikangas; Bernd Jilma; Bruno Flamion; Lyubina Racheva Todorova; Anna Paphitou; Ivana Haunerova; Toivo Maimets; Jean-Hugues Trouvin; Egbert Flory; Asterios Tsiftsoglou; Balázs Sarkadi; Kolbeinn Gudmundsson; Maura O'Donovan; Giovanni Migliaccio; Jānis Ancāns; Romaldas Maciulaitis; Jean-Louis Robert; Anthony Samuel; Johannes H Ovelgönne; Marit Hystad; Andrzej Mariusz Fal; Beatriz Silva Lima; Anca Stela Moraru; Peter Turcáni; Robert Zorec; Sol Ruiz; Lennart Akerblom; Gopalan Narayanan; Alastair Kent; Fabrizia Bignami; J George Dickson; Dietger Niederwieser; María-Angeles Figuerola-Santos; Ilona G Reischl; Claire Beuneu; Rosen Georgiev; Maria Vassiliou; Alena Pychova; Mette Clausen; Taina Methuen; Sophie Lucas; Martina Schüssler-Lenz; Vasilios Kokkas; Zsuzsanna Buzás; Niall MacAleenan; Maria Cristina Galli; Aija Linē; Jolanta Gulbinovic; Guy Berchem; Mariusz Fraczek; Margarida Menezes-Ferreira; Nela Vilceanu; Mikulás Hrubisko; Petra Marinko; Marcos Timón; Wing Cheng; George Andrew Crosbie; Nick Meade; Michelino Lipucci di Paola; Thierry VandenDriessche; Per Ljungman; Lucia D'Apote; Olga Oliver-Diaz; Isabel Büttel; Patrick Celis
Journal:  Nat Rev Drug Discov       Date:  2010-03       Impact factor: 84.694

6.  Genome editing technologies: defining a path to clinic.

Authors:  Jacqueline Corrigan-Curay; Marina O'Reilly; Donald B Kohn; Paula M Cannon; Gang Bao; Frederic D Bushman; Dana Carroll; Toni Cathomen; J Keith Joung; David Roth; Michel Sadelain; Andrew M Scharenberg; Christof von Kalle; Feng Zhang; Robert Jambou; Eugene Rosenthal; Morad Hassani; Aparna Singh; Matthew H Porteus
Journal:  Mol Ther       Date:  2015-05       Impact factor: 11.454

Review 7.  A roadmap toward clinical translation of genetically-modified stem cells for treatment of HIV.

Authors:  Mohamed Abou-El-Enein; Gerhard Bauer; Petra Reinke; Matthias Renner; Christian K Schneider
Journal:  Trends Mol Med       Date:  2014-09-25       Impact factor: 11.951

8.  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.

Authors:  Joerg J Meerpohl; Lisa K Schell; Dirk Bassler; Silvano Gallus; Jos Kleijnen; Michael Kulig; Carlo La Vecchia; Ana Marušić; Philippe Ravaud; Andreas Reis; Christine Schmucker; Daniel Strech; Gerard Urrútia; Elizabeth Wager; Gerd Antes
Journal:  BMJ Open       Date:  2015-05-05       Impact factor: 2.692

  8 in total
  3 in total

1.  Registry Contributions to Strengthen Cell and Gene Therapeutic Evidence.

Authors:  Mohamed Abou-El-Enein; David W Grainger; Sven Kili
Journal:  Mol Ther       Date:  2018-04-21       Impact factor: 11.454

Review 2.  Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials.

Authors:  Erika Kleiderman; Audrey Boily; Craig Hasilo; Bartha Maria Knoppers
Journal:  Stem Cell Res Ther       Date:  2018-11-08       Impact factor: 6.832

Review 3.  Clinical development of CAR T cells-challenges and opportunities in translating innovative treatment concepts.

Authors:  Jessica Hartmann; Martina Schüßler-Lenz; Attilio Bondanza; Christian J Buchholz
Journal:  EMBO Mol Med       Date:  2017-09       Impact factor: 12.137

  3 in total

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