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Study Shows Advantages of Complete Phase Ib Trial Over Separate,Phase I Trials

focus is to evaluate a drug's safety, including safe dosage range. Phase Ib studies are typically combinations of the new agent plus a standard agent.

The Translational Oncology Program (TOP) was founded in 2004 following a request from physicians affiliated with US Oncology to establish an early phase study program. TOP is comprised of a select group of US Oncology physicians who address standard Phase I study design and select Phase II studies. Members of the US Oncology Research Network met with investigators in January 2005 and TOP began its first study two months later. The program's goals include establishing a Phase I research infrastructure, eventually incorporating targeted therapy into its research efforts.

"What's exciting is that as TOP has evolved, the US Oncology Research Network has taken on more Phase I and II trials that are typically the newest, and often, the most novel approaches to cancer treatment that will ultimately benefit our patients," said Jeffery Nieves, Pharm D., Director or the Translational Oncology Program for the US Oncology Research Network.

"Early-stage trials conducted in a smaller, community setting can result in a speedier determination of a new agent's viability, eventually bringing new therapies to patients quicker."

Each TOP site is required to have a dedicated physician, research nurse and investigational/research pharmacist who have the experience and credentials to conduct phase I trials. In addition, each site must meet facility and equipment requirements to participate in early-stage trials.

TOP rounds are conducted weekly at each site and include an assessment of patient status and safety for all participants, a review of pending and priority protocol status, and discussion of new scientific concepts. In 2007, the 200th patient was accrued to a TOP trial.

About US Oncology Research

The US Oncology Research Network is an established community-based research operation spec
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