Clinical Trials Workshop Maps Out Strategy For Effective Drug Development Studies

Main Category: Clinical Trials / Drug Trials
Also Included In: Medical Students / Training;  Conferences
Article Date: 10 Feb 2009 - 2:00 PDT

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Day two of the SNM Clinical Trials Network Community Workshop convened on Monday, Feb. 9, in Clearwater, Fla., with more in-depth discussion on designing multicenter clinical trials using imaging biomarkers.

"The workshop was designed to give members of the molecular imaging community an overview of the specific steps that participating imaging sites can take to ensure that they are registered and qualified for participation in clinical trials of therapeutic drugs," said Robert Atcher, PhD, MBA, and president of SNM.

Importance of the Phantom Program Highlighted to Ensure Standardization and Harmonization

Building on the foundation laid the previous day, speakers from the field of molecular imaging, regulatory agencies and pharmaceutical developers focused on the importance of standardization and harmonization in the design of clinical trials, which is using imaging as an endpoint, among other topics. In particular, experts in oncology, cardiology and dementia discussed the critical role that clinical simulators, or phantoms, play in drug development studies.

"Currently there is not a standardized clinical imaging protocol used in promising investigational new drug (IND) studies. A standardized imaging protocol is not being used for radioactive fluorothymidine (18F-FLT), for example," said John M. Hoffman, MD, director of nuclear medicine at the Huntsman Cancer Institute at the University of Utah. "For the data to be of value in multi-site clinical trials, patient preparation, uptake time, image acquisition and reconstruction parameters, and data analysis must be the same across the multiple sites performing the study." In addition, there should be trial site qualification to assure image quality and quantitative integrity.

To address these and other quantitative issues, speakers noted SNM's long history of providing phantoms for multi-site comparison of image performance. Paul Christian, a certified nuclear medicine technologist and SNM Quality Assurance Committee Chair, explained that currently more than 100 hospitals successfully participate in an annual evaluation program to measure image quality in nuclear medicine.

"Phantom imaging is designed to evaluate how an imaging center acquires, processes and displays images, as well as how successfully physicians interpret them. For the first multicenter trial, precisely filled 18F-FLT phantoms will provide a clinical simulator capable of measuring a PET scanner's quantitative performance across multiple imaging sites," he said.

Lisa Karam, NIST, Underscores Importance of Quantitative Medical Imaging

Lisa Karam, PhD, with the National Institute of Standards and Technology (NIST), underscored the importance of quantitative medical imaging during her presentation and described ongoing collaborations with the National Institutes of Health National Cancer Institute (NCI), M.D. Anderson, and the Rensselaer Polytechnic Institute on approaches to accurately calibrate PET systems.

"The ability to calibrate diagnostic imaging tools to national standards will lead to a more quantitative approach and increased accuracy in treatment planning, increased patient safety and greater confidence in results from clinical trials," she stated.

The SNM Clinical Trials Network Workshop concluded with breakout sessions during which participants were given additional information about clinical trials, including centralized IND production; chemistry, manufacturing and control requirements; and other regulatory considerations.

"The key thing for the network is to be able to ensure that all sites involved in a particular trial can meet the necessary quality requirements and that data are validated across platforms and between sites," said Alexander McEwan, MD, and past president of SNM. "Currently, the network is on track to be fully functional in the first quarter of 2009. Details about specific clinical trials will be available later in the year."

For more information about registering your site or becoming involved in SNM's Clinical Trials Network, please visit http://www.snm.org/clinicaltrials.

SNM Clinical Trials Network Workshop