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 has made publicly available a relational database as a resource for aggregate analysis and characterization of the U.S. clinical trials enterprise. This resource is referred to as the database for Aggregate Analysis of ClincalTrials.gov (AACT) . A new paper describes the methodology for creating AACT using data from ClinicalTrials.gov and for creating specialty datasets that may facilitate analysis within specialty groups. AACT is a key component of the State of Clinical Trials project .
To enhance communications with all stakeholders, CTTI launched a new website on Friday, March 16. The site, www.ctti-clinicaltrials.org , has a new design layout as well as updated content to better relay the mission and goals and to make project information more accessible. CTTI will continue to look for ways to expand its communications and welcomes any suggestions in this regard.
FDA will hold a two-day public hearing on modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated products. The purpose of this hearing is to solicit input from a broad group of stakeholders on the scope and direction of this effort, including encouraging the use of innovative models that may enhance the effectiveness and efficiency of the clinical trial enterprise. In addition to receiving feedback at the meeting, FDA will accept written comments until May 31.
In August 2011, CTTI convened multiple stakeholders to discuss examples of how risk management and QbD principles can be applied to clinical trials and therapeutic development programs. The Executive Summary and Full Meeting Summary are now available.
CLICK HERE to view all of the meeting materials.
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....