Experts From Molecular Imaging, Regulatory Agencies And Pharmaceutical Industry Come Together To Advance Multi-Center Drug Development Trials

Main Category: Clinical Trials / Drug Trials
Also Included In: MRI / PET / Ultrasound;  Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 18 Feb 2009 - 0:00 PDT

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More than 150 physicians, imagers and pharmaceutical developers convened in Clearwater, Fla., Feb. 8-9, for an intensive workshop examining the need for streamlined drug discovery through the integration of imaging biomarkers into multi-center clinical trials.

Stakeholders from every facet of the drug discovery process came together at this year's annual SNM Molecular Imaging Summit to learn how SNM's new Clinical Trials Network can facilitate faster and more cost-effective drug development through the integration of imaging biomarkers into Phase 1, 2, 3 and 4 therapeutic clinical trials. The workshop outlined details of participation in the network and examined the critical need for standardization and harmonization across imaging sites.

"The demand for medical imaging in clinical trials is rapidly increasing due to the unique ability that imaging provides physicians to see and assess early on whether a course of treatment is working as intended for a patient," said Michael Graham, M.D., Ph.D., director of nuclear medicine at the University of Iowa College of Medicine in Iowa City, Iowa, and president-elect of SNM. "Molecular imaging is an essential component of personalized medicine, and we need the right tools in place to deliver on this potential."

"After listening carefully to the needs of these various, but interconnected communities, SNM has focused on the issue of limited harmonization of imaging protocols between multiple imaging centers," said SNM President Robert W. Atcher, Ph.D., M.B.A., and Emerging Medical Technology Team Leader at Los Alamos National Laboratory in New Mexico. "SNM will ensure the use of a consistent methodology and protocol across the multiple clinical trial sites, which is key to quality data generation and ultimate FDA approval of investigational therapeutics."

The use of imaging in clinical trials can help pharmaceutical developers determine earlier in the development process whether a new product is clinically promising - accelerating the development of promising compounds and eliminating those without apparent patient benefit earlier in the development cycle.

"It is important that interested imaging centers, drug manufacturers and other facilities get involved at this time as there are steps to be taken to ensure imaging standardization and to maintain imaging quality control across multiple sites," Atcher added.

The comprehensive workshop was held immediately after SNM's Mid-Winter Educational Symposium and featured presentations and discussions about methods and shortcomings of current drug development practices, the potential for imaging biomarkers in multicenter clinical trials, the role of the SNM Clinical Trials Network in drug development, and fundamentals of participation in the network.

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For more information about the SNM Clinical Trials Network, please visit http://www.snm.org/clinicaltrials.

About SNM

SNM is an international scientific and medical organization dedicated to raising public awareness about what molecular imaging is and how it can help provide patients with the best health care possible. SNM members specialize in molecular imaging, a vital element of today's medical practice that adds an additional dimension to diagnosis, changing the way common and devastating diseases are understood and treated.

SNM's more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit http://www.snm.org.

Source: Amy Shaw
Society of Nuclear Medicine

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