Document Actions
Collaborations
Up one levelIn addition to conducting projects, CTTI collaborates with other organizations in educational and research activities aimed at improving clinical trials. Collaborations to date include the following:
FDA Clinical Investigator Training Course
The third annual FDA Clinical Investigator Training Course, co-sponsored by the FDA and CTTI, was held on November 7 - 9, 2011, in Silver Spring, Maryland. The course provided clinical investigators with a greater understanding of the scientific, ethical, and regulatory aspects of clinical trials.
The video and slides are now available.
Standards for Collecting Information about Cardiovascular Events
CTTI is participating in a collaborative pilot project with the FDA and other organizations to develop standard definitions and data collection methods for cardiovascular events in clinical trials. While this effort focuses on cardiovascular events, it has relevance to other therapeutic areas because, increasingly, cardiovascular outcomes are being evaluated during the development of new biologics, devices, and drugs. The goal of this project is to provide uniformity for data collection so that results from clinical trials can be analyzed more easily and safety signals and trends may be identified.
The expected products are a repository of standardized definitions and a standard Case Report Form (CRF) for cardiovascular endpoint events.
Draft definitions for endpoint events in cardiovascular trials were posted on the CDISC website for public review. For more information click here.
Agenda and presentations for the March 26. 2010 meeting.
Agenda and presentations for the February 5, 2010 meeting.
Agenda and presentations for the September 11, 2009 meeting.
New Approaches to Clinical Trials: Implications for Comparative Effectiveness
An expert meeting was convened by the PACE Initiative (Pragmatic Approaches to Comparative Effectiveness) in May 2009 in collaboration with CTTI and the Center for Medical Technology Policy (CMTP) to discuss with policy-makers the premise that randomized controlled trials would be more commonly employed for comparing the effectiveness of medical products and procedures if: 1) operational efficiency were improved, 2) Bayesian adaptive principles were applied to trial design, and 3) the needs of decision-makers were addressed by more pragmatic trial designs that increased the generalizability of results. Click here for the full article.
View Entire Calendar