EMA's Release of Regulatory Data: Possible Fall out for Journals and Research Synthesis - Speaking of Medicine

abernard102@gmail.com 2014-11-03

Summary:

On 2 October the European Medicines Agency’s (EMA) published the final version of its policy on prospective release of clinical study reports (CSRs) of trials submitted by sponsors in support of Marketing Authorisation Applications (MAAs). I have summarized its content and made preliminary comments here ... In brief, from 1 January 2015 the proactive policy will join the current reactive policy and allow prospective access to incomplete CSRs at two levels: a 'viewer' level of access and a 'researcher' level. The former will allow on-screen viewing only with a simple registration procedure, while the latter will require proof of identity but allow download and OCR searches to be carried out on CSRs. Prospective seems to mean two things: after a regulatory decision has been taken, pharma will format and write CSRs for direct web posting, and once you have obtained access credentials, you will not have to ask every time you want a CSR and wait some months (and in some cases be turned down) ..."

Link:

http://blogs.plos.org/speakingofmedicine/2014/11/03/emas-release-regulatory-data-possible-fall-journals-research-synthesis/

From feeds:

Open Access Tracking Project (OATP) » abernard102@gmail.com

Tags:

oa.new oa.comment oa.data oa.clinical_trials oa.medicine oa.biomedicine oa.policies oa.pharma

Date tagged:

11/03/2014, 15:45

Date published:

11/03/2014, 10:45