News

Summaries Available - Workshop on Quality-by-Design in Clinical Trials — last modified February 28, 2012 01:13 PM - EST

CTTI Executive Director Authors Paper on Impediments to Clinical Research — last modified February 21, 2012 11:54 AM - EST

New FDA Guidance on Collection of Safety Data — last modified February 10, 2012 02:29 PM - EST

NIH creates website to help people learn about clinical trials — last modified February 07, 2012 04:38 PM - EST

FDA Center for Devices Releases 2012 Strategic Priorities — last modified January 26, 2012 01:00 PM - EST

Public Engagement and Clinical Trials: New Models and Disruptive Technologies-Workshop Summary — last modified January 25, 2012 02:40 PM - EST

The IOM Forum on Drug Discovery, Development, and Translation, in collaboration with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011 to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.

Sex-specific reporting of scientific research-workshop summary — last modified January 17, 2012 01:31 PM - EST

CTTI Announces Search for Executive Director — last modified December 02, 2011 04:24 PM - EST

CTTI Workshops to Develop Principles for Applying Quality Framework to Clinical Trials — last modified November 22, 2011 02:11 PM - EST

New Project to Promote Responsible Safety Oversight — last modified November 22, 2011 12:50 PM - EST

Project Update: Site Metrics — last modified November 16, 2011 10:38 AM - EST

FDA Draft Guidance for Monitoring — last modified October 07, 2011 09:05 AM - EST

EMA Releases Paper on Risk Based Quality Management — last modified October 07, 2011 09:05 AM - EST

Patient Representative selected for CTTI Steering Committee — last modified August 30, 2011 08:35 AM - EST

CTTI Seeks Nominations for At-large Position on Steering Committee — last modified August 25, 2011 03:26 PM - EST

CTTI study highlights variability of monitoring approaches — last modified July 05, 2011 05:16 PM - EST

FDA Perspective on Safety Rule — last modified June 13, 2011 11:46 AM - EST

Third Annual Food and Drug Administration's Clinical Investigator Training Course — last modified May 26, 2011 02:06 PM - EST

CTTI Releases Recommendations — last modified May 20, 2011 11:52 AM - EST

CTTI presents project results and updates this week at the Society for Clinical Trials (SCT) Annual Meeting — last modified May 16, 2011 04:12 PM - EST

Site Metrics for Study Start-Up Expert Meeting — last modified May 13, 2011 02:11 PM - EST

CTTI seeks nominations for patient representative — last modified April 21, 2011 04:04 PM - EST

New Report on Approaches to Quality Management in Clinical Trials — last modified March 09, 2011 02:19 PM - EST

CTTI 2010 Accomplishments Report — last modified March 08, 2011 03:01 PM - EST

CTTI announces new project — last modified January 26, 2011 09:26 AM - EST

CTTI welcomes new member organizations — last modified January 25, 2011 11:16 AM - EST

FDA Collaborative Initiative Announces Standard Cardiovascular Endpoint Definitions Posted for Public Review — last modified December 15, 2010 12:17 PM - EST

FDA Clinical Investigator Training Course slides, videos and transcripts are now available — last modified December 15, 2010 12:12 PM - EST

Monitoring Project Expert Meeting — last modified November 08, 2010 05:43 AM - EST

CTTI Announces New Project — last modified September 29, 2010 05:31 PM - EST

FDA Issues Final Rule Addressing Safety Reporting Requirements — last modified September 28, 2010 05:58 PM - EST

Final Report Now Available for Workstream 2 of the Monitoring Project — last modified September 24, 2010 04:32 PM - EST

Monitoring Project Expert Meeting Summary — last modified September 24, 2010 12:30 PM - EST

Preliminary Results Available for Monitoring Project — last modified August 16, 2010 03:05 PM - EST

Food and Drug Administration's Clinical Investigator Training Course — last modified August 10, 2010 02:54 PM - EST

Co-sponsored by FDA's Office of Critical Path Programs and Clinical Trials Transformation Initiative

CTTI Welcomes New Members — last modified July 13, 2010 03:24 PM - EST

CTTI participates in the Society for Clinical Trials (SCT) 31st Annual Meeting — last modified May 14, 2010 11:37 AM - EST

CTTI welcomes new members — last modified April 28, 2010 05:50 AM - EST

Standardized Data Collection for Cardiovascular Trials Meeting Update — last modified April 16, 2010 12:24 PM - EST

Concept Update — last modified April 09, 2010 01:05 PM - EST

Presentations available for Standardized Data Collection for Cardiovascular Trials Meeting — last modified March 17, 2010 01:10 PM - EST

Updated Information on CTTI Collaborations — last modified December 23, 2009 12:48 PM - EST

CTTI Announces New Approved Concepts — last modified November 06, 2009 02:13 PM - EST

Norman Fost, At-large member of CTTI Steering Committee — last modified September 29, 2009 07:45 AM - EST

Food and Drug Administration's Clinical Investigator Training Course — last modified August 21, 2009 10:53 AM - EST

Co-sponsored by FDA's Office of Critical Path Programs and Clinical Trials Transformation Initiative

Steering Committee Selects Patient Representatives — last modified July 21, 2009 01:32 PM - EST

SAE Reporting Project Plan Now Available — last modified April 17, 2009 02:14 PM - EST

April 6, 2009

Nominations sought for patient representatives — last modified February 24, 2009 04:42 PM - EST

Active involvement, enthusiasm mark CTTI’s first year — last modified February 10, 2009 10:50 AM - EST

Fifty-one organizations joined CTTI in 2008. Each is represented on the CTTI Steering Committee. An Executive Committee was also established to provide overall direction and leadership.

Monitoring Project Plan Now Available — last modified January 30, 2009 02:49 PM - EST

Steering Committee Selects Co-chairs — last modified January 23, 2009 09:47 AM - EST

The CTTI Steering Committee has selected James J. Ferguson III, M.D. and Briggs Morrison, M.D. to preside as co-chairs.

EMEA Joins Executive Committee — last modified January 05, 2009 03:22 PM - EST

The European Medicines Agency has named Senior Medical Officer Hans-Georg Eichler, M.D., M.Sc. the first non-US regulatory liaison to the Clinical Trials Transformation Initiative Executive Committee.

Coalition to Transform Clinical Trials Names Executive Board — last modified May 05, 2008 03:23 PM - EST

The Clinical Trials Transformation Initiative (CTTI) has named a 12-member Executive Board that will oversee its activities.

FDA and Duke Collaborate to Modernize Clinical Trials — last modified April 01, 2008 12:23 PM - EST

Under an agreement between the U.S. Food and Drug Administration and Duke University Medical Center , Duke will host a Public-Private Partnership that will include broad representation from government, industry, patient advocacy groups, professional societies, and academia.

FDA Critical Path Initiative Announcement — last modified April 01, 2008 12:22 PM - EST

The U.S. Food and Drug Administration and Duke University Medical Center have begun a collaboration aimed at modernizing the way clinical trials are conducted.