Buried Clinical Trial Data: The Dam Is About To Burst

abernard102@gmail.com 2015-01-16

Summary:

" ... In the first development, a preliminary report from the prestigious Institute of Medicine lends strong support to the open data movement. The IOM report states that investigators should be required to establish a data-sharing plan at the same time the trial is registered. The report includes detailed recommendations for when and how the data should be made available. Among the major recommendations: data underlying a trial analysis should be made available within 6 months after journal publication, and all data should be made available no later than 18 months after the last patient visit in the trial. In the second development, the Yale University Open Data Access (YODA) Project announced that Johnson & Johnson is expanding its plans to share data. The company had previously announced that it planned to share data from its large drug portfolio. Now the company has announced that it will also share data from its device and diagnostic trials — a first in the field. YODA will act as 'a fully independent intermediary to manage requests and promote data use,' said YODA. The project will have 'full control' over the data ..."

Link:

http://www.forbes.com/sites/larryhusten/2015/01/14/hidden-clinical-trial-data-the-dam-is-about-to-burst/

From feeds:

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

Tags:

oa.new oa.comment oa.data oa.clinical_trials oa.reports oa.recommendations oa.iom oa.johnson&johnson oa.yoda oa.yale.u oa.pharma

Date tagged:

01/16/2015, 10:22

Date published:

01/16/2015, 05:22