This is your one stop shop for updates on CTTI projects, developments in the clinical trials enterprise and other relevant news. To read the full-length entry, or to share a specific blog post, click on the title of the article of interest.
In a recently published paper, Drs. Judith Kramer, Robert Califf and Brian Smith discuss the impediments to clinical research conducted in the U.S., including well-intentioned efforts to minimize undesirable results within individual sectors of the system. The authors stress the importance of all stakeholders working together to streamline the system so we can efficiently generate reliable information about the benefits and risks of treatment options for patients. CTTI is doing just that with the help of our members and in collaboration with others who are also working on this issue....
The FDA has released a draft guidance for industry on determining the extent of safety data collection needed in late stage premarket and postapproval clinical investigations. The guidance emphasizes a selective and better targeted approach. Information about how to submit comments regarding the draft guidance can be found in the Federal Register notice .
The National Institutes of Health (NIH) has announced a new website " CLINICAL RESEARCH TRIALS AND YOU " where people can go to learn more about clinical trials, why they matter, and how to participate.
As we release our 2012 Strategic Priorities, we are proud to report on our accomplishments from 2011. We completed work on fifty action items in 2011. Highlights of the significant amount of work our staff accomplished in 2011 include:
CTTI is now seeking qualified candidates for Executive Director. Judith Kramer, MD, MS, the current Executive Director, recently announced her plans to transition to the role of senior scientific advisor once a new Executive Director is named. In her new role, Dr. Kramer will support project teams in the development and execution of CTTI projects.
CTTI is a public-private partnership formed in 2007 by the U.S. Food and Drug Administration and Duke University to modernize the way clinical trials are conducted. CTTI has over 60 member organizations with broad representation of...