Food and Drug Administration and Duke Clinical Research Institute to Host a Cardiac Safety Think Tank
Posted on: Monday, 12 September 2005, 09:00 CDT
DURHAM, N.C., Sept. 12 /PRNewswire/ -- On October 11, 2005, the Duke Clinical Research Institute (DCRI) and the Food and Drug Administration (FDA) will host the Cardiac Safety and Critical Path Initiative Think Tank in Bethesda, Maryland. This meeting will foster communication and cooperative efforts between academic research institutions, industry members, professional societies, and government agencies to improve cardiac safety evaluation of drugs and drug-device combinations through the application of Critical Path Initiative principles.
The "critical path" from concept to a new medical product has become increasingly lengthy and costly. Complicating this process is the inconsistency between the types of studies that yield adequate efficacy data and the types of studies necessary for definitive safety assessments. Seeing the number of approvals decline, FDA launched its Critical Path Initiative to find new tools to predict safety and efficacy at the earliest possible time in the development process.
Improving cardiac safety is a priority of the Critical Path Initiative. One example of how regulatory authorities, subject matter experts in academia, and industry can cooperate in evaluating cardiac safety data is a nascent project to study electro-cardiograms (ECGs) collected in clinical trials and stored in an ECG warehouse. FDA is poised to partner with DCRI staff and other experts in the field to analyze these data with the goals of identifying early predictors of cardiac risk and informing drug development.
Dr. Christopher Cabell, Associate Director of the DCRI eECG Core Laboratory, states, "We are looking forward to co-hosting this cardiac safety think tank with the FDA. The Critical Path Initiative is a strategic step forward to ensure patient safety and to provide new, more efficacious therapies to those patients. The DCRI is proud to work with the FDA and other members of the pharmaceutical safety industry to provide a framework for advancing our collective knowledge in this important field."
The goals of the Cardiac Safety and Critical Path Initiative Think Tank are:
- To identify priorities for Critical Path projects related to cardiac safety - To describe common infrastructure necessary to support these projects - To identify technical, economic, and political barriers to implementing this infrastructure - To develop the preliminary framework and mechanisms for intra-industry collaborations
Please go to the upcoming meeting sections of the FDA (http://www.fda.gov/) or the DCRI (http://www.dcri.org/) homepages for additional information and to register for this event. If you have any questions, contact Mr. Scott Neff at (919) 668-7522.
Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Christopher Cabell, MD http://profnet.prnewswire.com/ud_public.jsp?userid=10000670
Duke Clinical Research Institute
CONTACT: Scott Neff, +1-919-668-7522, for Duke Clinical ResearchInstitute
Web site: http://www.dcri.org/http://www.fda.gov/
Source: PRNewswire
Related Articles
- Leading Italian ISP ITnet Selects Critical Path's Memova(R) Anti-Abuse With Cloudmark Authority to Protect Subscriber Emails
- ARYx Granted Clearance to Initiate Clinical Study of Antipsychotic Drug
- International Drug Safety Expert, Dr. Alastair J.J. Wood, Joins Critical Path Institute Board of Directors
- Dr. Peter B. Corr Joins Critical Path Institute Board of Directors
- New Federal Legislation Authorizes Innovative Partnerships for FDA's Critical Path Initiative
- Hollis-Eden Pharmaceuticals Cleared By FDA to Initiate Phase I Clinical Trial With HE3286 in Treating Metabolic Disorders
- FDA to Overhaul Clinical Trial Oversight
- Produce Safety &Amp; Security International, Inc. Responds to FDA and Fresh Produce Industry's Concern Over the Presence of E. Coli H157
- BIO and 21 Patient Groups Issue Letter Supporting FDA's Critical Path Initiative
- Tiscali Improves Consumer Experience With Memova Messaging From Critical Path
 |
 |
User Comments (0)
RSS Feeds