EDICT Project Releases White Paper on the Shortcomings of How Clinical Trials are Designed, Carried Out and Funded in the U.S.
(Washington, DC – April 1, 2008) EDICT Project releases a new white paper on major shortcomings in the way clinical trials are designed, carried out and funded in the United States with a press conference at the National Press Club in the nation's capital.
View the press conference . . .
http://www.bcm.edu/edict/RA/EDICT_Press_Conference_4-1-20008.ram
See booklet describing the project . . .
http://www.bcm.edu/edict/PDF/EDICT_Project_Booklet.pdf
Read the white paper . . .
http://www.bcm.edu/edict/PDF/EDICT_Project_White_Paper.pdf
Review the latest draft of the policy recommendations . . .
http://www.bcm.edu/edict/PDF/EDICT_Project_Policy_Recommendations.pdf
And read a news story about release of the white paper . . .
U.S. News and World Report news story
EDICT Project Completes Public Comment Period for Clinical Trials Policy Recommendations
(Houston, Texas – March 21, 2008) Using the same process as government agencies when implementing new policies, a national alliance of scientists, public health leaders, and community representatives called for public comment on a series of proposals designed to eliminate continued disparities in U.S. clinical trials. In response to this call feedback was collected online to each of the 33 specific recommendations from March 3, 2008 through March 21, 2008.
Download the March 3, 2008 press release . . .
http://www.bcm.edu/edict/PDF/EDICT_Press_Release_20080303.pdf
Or go directly to the latest draft of the policy recommendations . . .
http://www.bcm.edu/edict/PDF/EDICT_Project_Policy_Recommendations.pdf
Project Response to the Centers for Medicare & Medicaid Services' Decision Memorandum on its Clinical Trials Policy
On October 17, 2007, the Centers for Medicare & Medicaid Services ("CMS") issued its Final Decision Memorandum on its Clinical Trials Policy ("CTP"). This Memorandum ended a phase of commentary that began in April 2007, when CMS indicated it would reconsider the CTP for the first time since 2000. The EDICT Team is pleased to have participated extensively in this latest round of conversations, and has collated the following documents to assist stakeholders in navigating the policy discourse:
EDICT Team's Response to the Oct. 17 Final Decision Memorandum
CMS's "Questions and Answers" regarding the Oct. 17 Final Decision Memorandum
EDICT Team's Comments in support of CMS's July 19th Proposed Decision Memorandum
EDICT Team's Initial Comments in Response to CMS's April 2007 Initiation of the Reconsideration Process
For more information, please contact the Chronic Disease Prevention and Control Research Center at 713-798-4614 or edict@bcm.edu.
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