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The FDA has released a draft guidance for industry on determining the extent of safety data collection needed in late stage premarket and postapproval clinical investigations.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 Information about how to submit comments regarding the draft guidance can be found in the Federal Register notice .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:
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.
The FDA has published a draft guidance document regarding the use of a risk-based approach to monitoring. Click here to see the document. Of note, results from the CTTI monitoring project were acknowledged within the draft guidance.