US House Bill Aims to Expand Release of Clinical Trials Data

abernard102@gmail.com 2013-05-22

Summary:

"The latest bill, known as the Trial and Experimental Studies Transparency (TEST) Act of 2013, seeks to address a number of loopholes in the registration and publication of trial data in the US online database. Currently, a portion of clinical trials used for US drug approvals -- including some conducted in foreign countries, as well as Phase I and feasibility studies -- are not required to be registered with clinicaltrials.gov. Clinical trial protocols and informed consent documents are also not included in a list of documents submitted to clinicaltrials.gov, but would be added under the bill. The addition of such documents could pose privacy and proprietary investment issues, as well as add a significant burden for the companies running the trials, some experts claim . However, others such as the Patient Consumer and Public Health Coalition, have said that an increase in the flow of more specific trial data could save industry resources and redundancy. 'If we were issuing a grade on the clinical trials report card, it would be Incomplete,' said Rep. Ed Markey (D-Mass.), senior member of the Energy and Commerce Committee, who introduced the bill. 'Unreported results and missing registrations leave participants, doctors and researchers vulnerable.'"

Link:

http://www.in-pharmatechnologist.com/Regulatory-Safety/US-House-Bill-Aims-to-Expand-Release-of-Clinical-Trials-Data

From feeds:

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

Tags:

oa.new oa.comment oa.government oa.usa oa.legislation oa.pharma oa.clinicaltrials.gov oa.biomedicine oa.clinical_trials oa.test

Date tagged:

05/22/2013, 10:18

Date published:

05/22/2013, 06:18