UPCOMING EDUCATIONAL OPPORTUNITIES
January 27-February 2, 2010, Albuquerque, New Mexico:
SNM Conjoint Mid-Winter Meetings
2010 MWM Website
Meeting Planner
Clinical Trials Workshop 2010: Molecular Imaging in Clinical Trials
View Agenda
RECENT EVENTS
October 19-21, 2009, Bethesda, Maryland:
CMOD Biomarkers and Surrogate Endpoints Symposium
"Streamlining to Promote Innovation and Efficiency"
View Agenda
September 9th, 2009, 7:00am Eastern U.S. / 1:00pm London / 2:00pm Western:
Introduction to the Clinical Trials Network: Highlights for European PET Manufacturers
View Webinar Agenda
Welcome to the Clinical Trials Network
A major barrier to the development of new and effective drugs has been the time, complexity and cost of the regulatory process. In recent years, the potential for imaging biomarkers to reduce this burden on the drug development process has become widely accepted as a means to speed the time to clinical use.
In October, 2008, SNM leadership announced the creation of the SNM Clinical Trials Network. The Network is a collaborative effort designed to address the widely recognized need for validated imaging biomarkers to be used in streamlining the development and registration of investigational therapeutics. The Network will create multicenter investigational new drug (IND) applications that will be available to cross-reference in clinical trials of investigational therapeutics that require INDs for imaging agents, to assess response to treatment or to stratify patients for enrollment in clinical trials. The plan specifically includes creation of a Biomarker Use Pathway.
The Biomarker Use Pathway will coordinate the planning and data collection of multicenter clinical trials that include the use of imaging biomarkers (e.g. radiopharmaceuticals, contrast agents, bioluminescence agents, etc). In cooperation with the FDA and its extensive membership of imagers and radiopharmaceutical manufacturers, the SNM Clinical Trials Network plans to generate centralized, multi center IND applications and facilitate the successful participation of imaging centers and local radiopharmaceutical manufacturing sites under the stringent regulatory conditions of clinical trials.
This program is anticipated to facilitate the use of imaging biomarkers in Phase 1, 2 and 3 clinical trials, stimulate the development of additional novel biomarkers, and develop standardized and reproducible protocols for the use of these probes.
LAST UPDATED: 12/15/2009