February 2, 2010
Workshop: Successful Integration Of Imaging Biomarkers Into Clinical Trials
Maximizing quality in clinical trials is emphasized at this year's gathering of experts from molecular imaging centers, biomarker manufacturers, regulatory agencies and the pharmaceutical industry
A community workshop sponsored by SNM's Clinical Trials Network (CTN) officially kicked off on Feb. 1, in Albuquerque, N.M., and presented participants with a series of educational sessions on the use of molecular imaging in clinical trials for investigational therapeutic drugs. Highly qualified leaders in medicine, industry and government shared their insights and expertise with a community that is given a unique opportunity to learn, in great detail, the inner workings of imaging in clinical trials.
Speakers Set the Stage
Building on last year's workshop, held in Clearwater, Fla., this year's Clinical Trials Network Workshop boasts a line-up of well-known leaders in clinical trials, molecular imaging and radiopharmaceuticals. The workshop features sessions that are designed to provide specific information on a wide variety of topics related to molecular imaging in multicenter clinical trials.
"It is impressive to see how the Clinical Trials Network has grown in such a short time, and its success is based largely upon the knowledge and expertise of the speakers presenting at this very workshop," said Dr. Conti.
By way of breakout sessions that featured presentations, panel discussions and case studies, the speakers helped participants navigate through the procedural, logistical and regulatory challenges that accompany multicenter clinical trials. In order for data from clinical trials to be validated and effective, the imaging sites must follow the exact same procedures, including patient preparation, image acquisition and data analysis methods.
The Building Blocks of Clinical Trials
One of the CTN's major initiatives is to ensure standardization of all imaging data in clinical trials in order for them to be effective and successful and to be able to harmonize the data at the end of the trial. A large part of achieving this goal is through the CTN's network of imaging sites. The earlier part of the first day of the workshop featured sessions that brought attendees up-to-date on the current challenges of clinical trials and set the stage for how to best overcome them.
Michael M. Graham, Ph.D., M.D., president of SNM and a co-organizer of the workshop, gave a report this morning that updated attendees on the Clinical Trials Network's most recent activities.
"Since molecular imaging biomarkers are so important to speeding the research and availability of therapeutic drugs, the Clinical Trials Network has made the methodology to standardize imaging data across multiple sites a high priority," said Dr. Graham. "This year's meeting reflects that sense of urgency and aims to bring greater understanding to all parties who can make this possible."
From the Big Picture to Nuts and Bolts
The second session of the day identified critical elements of imaging in high-quality multicenter research. Speakers gave presentations on protocol design, documentation and reporting, technologist education, and the nuts and bolts of site qualification and validation.
Paul E. Christian, C.N.M.T., B.S., P.E.T., leader of SNM's Clinical Trials Network's phantom program, gave a presentation on how a site's PET or PET/CT scanner can be validated for clinical trials through the phantom program. "I applaud SNM's continuing efforts to improve imaging quality through clinical assessments of phantoms for validation, function and quality," he said. "This workshop illustrates the importance of standardization for ensuring quality data among multiple sites, which is key to FDA approval of investigational therapeutics."
On Tuesday's Agenda
Tomorrow, the workshop continues with more sessions on how to participate in clinical trials, as well as a curriculum geared toward technologists who play a role in carrying out the imaging protocols. There will also be a number of sessions devoted to helping manufacturing sites grasp the new regulations for PET imaging agents, which were recently announced by the U.S. Food and Drug Administration (FDA) and will go into effect on Dec. 11, 2011.
Sally W. Schwarz, M.S., R.Ph., B.C.N.P., research associate professor of radiology at Washington University in St. Louis, said, "We are impressed with the ongoing efforts of the molecular imaging community and the producers of high-quality PET radiopharmaceuticals to work with the Clinical Trials Network and the FDA to increase the utilization of PET imaging. This CTN workshop will highlight the implications of the new FDA regulation and guidance for Current Good Manufacturing Practice (CGMP) for PET Drugs in the production of clinical and investigational PET drugs." Schwarz added that complying with the new regulations is an important issue for the entire community.
Louis Marzella, M.D., Ph.D., acting deputy director in the division of medical imaging and hematology products (DMIHP) at the FDA, said, "FDA is enthusiastic about SNM's efforts to work with the FDA and the drug development community to increasingly support the further development of safe and effective molecular imaging agents, drugs and biologics." Dr. Marzella added, "Imaging in clinical trials is an area of great potential, and we look forward to seeing it advance the field of medicine."
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