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.
The FDA has released a draft guidance for industry on determining the extent of safety data collection needed in late stage premarket and postapproval clinical investigations.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 Information about how to submit comments regarding the draft guidance can be found in the Federal Register notice .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:
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.