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Diagnostic Imaging. Vol. 31 No. 6
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Clinical trials network deals with startup growing pains

Program needs drug company sponsors before it
can pursue research and probe development goals

By James Brice | June 1, 2009

Despite progress on several fronts, the SNM Clinical Trials Network has received a cool response from recession-shocked pharmaceutical companies whose participation and financial support are considered crucial to the program's success.

About 20 pharmaceutical firms were contacted about participation as of May 1. Cochair Dr. Peter Conti, director of nuclear medicine at the University of Southern California, flew to the East Coast in April for several one-on-one meetings.

Early talks coincided with the economy's slide into recession, said Dr. Robert Atcher, SNM president.

“The irony is that there is obviously recognition about the value of clinical trials, but we picked a really rotten time, in terms of the economic situation, to raise money and support,” Atcher said.

Most potential collaborators have accepted the concepts underlying the network, but as of May 1, they had not agreed to some details involved in participation. The network aims at establishing the value of imaging biomarkers of disease to streamline therapeutic drug development, according to Atcher.

Biotechnology pioneer Genentech is an early supporter. It joined the network in March, shortly before the company's $48.6 billion buyout by Roche Pharmaceuticals. The cost of network participation for Genentech is more than $100,000. Other collaborations may involve much more money.

The network needs four or five more bankable checks in similar amounts to get started. First on the to-do list is the installation of quality assurance programs at up to 40 sites for the first round of clinical trials designed and implemented by its drug company sponsors, according to Dr. David Graham, one of three network cochairs and director of nuclear medicine at the University of Iowa Carver College of Medicine. Planning for the Genentech project will move forward independently.

“This is a critical piece because we aren't going to have the finances needed to do this unless we get pharmaceutical company involvement,” he said.

The network seeks to do what imaging researchers have long said could be done with FDG-PET as a biomarker of cancer cell metabolism, said network cochair Dr. Alexander McEwan. The scientific community never gained enough experience with FDG-PET in a structured clinical trial to show with certainty that physiological measures acquired with the agent could serve as a surrogate marker of therapeutic response.

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