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.
CTTI is pleased to announce a new project aimed at promoting responsible oversight of safety for pre-market products consistent with the intent of the FDA's new IND safety rule. For more information about the project, click here .
A key conclusion of the CTTI monitoring project was that clinical trial monitoring should be viewed as one component of an overall quality framework. Building on that effort, CTTI plans to hold a series of workshops to develop "quality-by-design" (QbD) and risk management principles that are broadly applicable to clinical trials, as well as to identify promising approaches to implement these principles. The first workshop was held in August 2011.
The summary of the Site Metrics for Study Start-up project has been updated to reflect recent progress by the team.
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...
CTTI is pleased to announce that the Executive Committee has approved a new project - Use of Central IRBs for Multicenter Clinical Trials. The goal of the project is to identify potential solutions to address barriers to the adoption of central IRBs for multicenter clinical trials. Click here for additional information about the project.