BioCentury on BioBusiness,
Regulation
EMA weighs divergent opinions on access to patient-level trial data
EMA pressured on gateways
By Stephen Hansen
Senior Writer
Published on
Monday, December 10, 2012
While industry would like to
restrict access to patient-level clinical trial data in Europe through a
gatekeeping mechanism, opponents are telling EMA that anything less than
open access will simply perpetuate the existing disclosure system and prevent
third-party analyses from being reproduced.
Industry wants the agency to
adopt a gatekeeping model following some - but not necessarily all - of the
system used by GlaxoSmithKline
plc, which requires third-party
researchers to submit their analysis plans for review by an independent panel
of experts.
83
words displayed of
1654
words total.
To read this article, you must be an Archives subscriber. Please choose one of the options below.
All contents Copyright © 1993-2013 BioCentury Publications, Inc. ALL RIGHTS RESERVED. All use of this Web Site and its contents is governed by the BioCentury User Agreement and the BioCentury Terms of Use. The contents of this Web Site are protected under U.S. and foreign copyright and intellectual property laws, and no part of this Web Site or its contents may be photocopied, reproduced or retransmitted in any form without the written consent of BioCentury, which may be requested from Reprints/Permissions at www.biocentury.com. BioCentury®; The Bernstein Report on BioBusiness™; The BioCentury 100™; The Clear Route to ROI™; Because Real Intelligence is Hard to Find™; BCIQ™; and BioPharma's Knowledge Center™; are trademarks of BioCentury Publications, Inc., P.O. Box 1246, San Carlos, CA 94070. SciBX® and SciBX: Science-Business eXchange® are trademarks of Nature America, Inc. that are jointly used by BioCentury Publications, Inc. and Nature America, Inc.
|
Current Subscribers
If you are a current subscriber, log in below or in the upper right corner of this
page.
Log In
Subscription Option
Whether you want an individual subscription or need a global group license, we have the products,
the experience and the customer support that biopharma executives, researchers, investors, service providers,
and industry stakeholders have trusted for nearly two decades.
Let our Subscriber Services team customize the best intelligence package available in the industry to meet your needs.
Free Trial 4 Weeks of Access
Get a 4-week free trial subscription to see the important articles you are missing.
Get 4 Weeks Free
Thank You
Thanks for purchasing this article.
Please bookmark this url for future reference.
We have also sent you a confirming e-mail with a receipt and this same url for your
records.
close [ X ]